CDSCO device alerts and monthly lab alerts
Medical device alerts and failed lab tests
Last checked 3 November 2026
CDSCO publishes device alerts in its general alerts table, mixed in with every other alert type. It has published none since 8 May 2023. Recalls under Rule 89 of the Medical Devices Rules 2017 are not listed publicly, so a recall that is not in the alerts table is not visible here. The rows below the alerts are device entries pulled from CDSCO's monthly lab alerts: 135 batches of items such as absorbent cotton, gauze, syringes, IV sets and catheters.
CDSCO device alerts, newest first
What this list covers. The device alerts CDSCO has posted since 2018 sit in CDSCO's alerts table. The entries below are the ones identified. For the alerts where the table title is not repeated here, open the alerts table and look for the date. Each download link there is a wrapper page, not the PDF itself.
| Date | Device | Maker | What the alert said |
|---|---|---|---|
| 8 May 2023 | Vivinex iSert toric intraocular lenses | HOYA | Class II recall, begun 12 Apr 2023. The last device alert CDSCO has published. Read the PDF |
| 29 Dec 2022 | Medical device alert dated 29 Dec 2022 (title as listed; device named in the PDF) | Named in the alert | Posted 4 Jan 2023. Alerts table |
| 21 Jul 2022 | Medical device alert dated 21 Jul 2022 (device named in the PDF) | Named in the alert | Posted 21 Jul 2022. Alerts table |
| 21 Jun 2022 | Medical device alert dated 21 Jun 2022 (device named in the PDF) | Named in the alert | Posted 21 Jun 2022. Alerts table |
| 14 Jun 2022 | Medical device alert dated 14 Jun 2022 (device named in the PDF) | Named in the alert | Posted 14 Jun 2022. Alerts table |
| 8 Nov 2021 | Medical devices alert of 8 Nov 2021 (device named in the PDF) | Named in the alert | Posted 8 Nov 2021. Alerts table |
| 11 Oct 2021 | MiniMed 620G and 640G insulin pumps and pump kits | India Medtronic Ltd | Medical devices alert on the two pump models. Alerts table |
| 17 Sep 2021 | HeartWare HVAD ventricular assist device | Medtronic | Field safety notice circulated as an alert. Alerts table |
| 9 Aug 2021 | Ventilators | Philips | Medical devices alert, August 2021 (the Respironics sleep and respiratory care recall). Alerts table |
| 2 Jul 2019 | Medical devices alert, July 2019 (device named in the PDF) | Named in the alert | Posted 2 Jul 2019. Alerts table |
| 20 May 2019 | Medical device alert dated 20 May 2019 (device named in the PDF) | Named in the alert | Posted 20 May 2019. Alerts table |
| 17 Oct 2018 | Ozurdex dexamethasone intravitreal implant 0.7 mg | Named in the alert | Recall notice (a drug implant, listed with devices). Alerts table |
Devices that failed a government lab test
What a row means. A state or central lab tested a sample and declared it not of standard quality. One row is one batch. The usual reason for these devices is sterility. A failed batch is not a finding against the maker's other batches or products.
2026
| Product | Batch | Manufacturer | Reason | Tested by | Alert |
|---|---|---|---|---|---|
| Absorbent cotton Gauze IS 758 (Non-Sterile) | AG67/25 | Pankajavale Product | Absorbency | Drug Testing Laboratory, Chennai-6 | Sep 2026 |
| Absorbent Cotton wool I.P | 911 | Rishabh Texco Pvt Ltd, Rajasthan | Sulphated Ash, water soluble substances and Fluorescence | Drug Testing Laboratory, Chennai-6 | Sep 2026 |
| Absorbent Cotton wool I.P. | R/0500/347 | Mohini Health & Hygiene Ltd, Madhya Pradesh | Neps | Drug Testing Laboratory, Chennai-6 | Sep 2026 |
| Absorbent Cotton wool IP | 2121 | Jind Surgicals, Haryana | Fluorescence, Neps and Sulphated Ash | Drug Testing Laboratory, Chennai-6 | Sep 2026 |
| Absorbent Cotton wool IP | R/0500/197 | Mohini Health & Hygiene Ltd, Madhya Pradesh | sinking time and Neps | Drug Testing Laboratory, Chennai-6 | Sep 2026 |
| Absorbent Cotton wool IP | 950 | Rishabh Texco Pvt Ltd, Rajasthan | Fluorescence and sulphated Ash | Drug Testing Laboratory, Chennai-6 | Sep 2026 |
| Absorbent Cotton wool IP | R/0500/355 | Mohini Health & Hygiene Ltd, Madhya Pradesh | Neps | Drug Testing Laboratory, Chennai-6 | Sep 2026 |
| Absorbent Cotton wool IP | 1662 | Mamta Spinners Pvt Ltd | Surface active substances, Fluorescence, Neps and sulphated Ash | Drug Testing Laboratory, Chennai-6 | Sep 2026 |
| Absorbent Gauze (Super Deluxe) IS 758 (NOT STERILIZED) | G 43 | Muthu Surgicals | Width and Absorbency | Drug Testing Laboratory, Chennai-6 | Sep 2026 |
| Absorbent Gauze IS 758 | G 43 | Muthu Surgicals | Threads / dm(ends), mass, Length and width | Drug Testing Laboratory, Chennai-6 | Sep 2026 |
| Cotton Roll Bandage 15 CMX3MTRSX10 ROLLS | RB28 | Jai Krishna Enterprises, Tamil Nadu | Sample does not comply Ends, Picks, Mass for cotton rolled Bandage as per BIS 863:2023. Medical Textiles- Cotton Bandage cloth specifications. | State Lab, DCL, Telangana | Sep 2026 |
| Gauze and cotton Tissue BP 1988 | 05 | Sri Sandana Magalingam Textiles | Threads per 10cm - wrap and weft | Drug Testing Laboratory, Chennai-6 | Sep 2026 |
| Rolled Bandage As Per Schedule F(II) Unsterilized | 687 | Tulip Surgicals, Rajasthan | The sample does not conform to claim as per Schedule F-(II) with respect to test of length | CDL, Kolkata | Sep 2026 |
| Rolled Bandage As Per Schedule F(II) Unsterilized | 678 | Tulip Surgicals, Rajasthan | The sample does not conform to claim as per Schedule F-(II) with respect to the test for length | CDL, Kolkata | Sep 2026 |
| Roller Bandage (Bange cloth cut IS 863) | 04 | Sri Sandana Magalingam Textiles | Description, Threads and mass | Drug Testing Laboratory, Chennai-6 | Sep 2026 |
| surgical Gauze & Bandage Cloth | 02 | Sri Sandana Magalingam Textiles | Threads - ends , Picks, Mass, Length, width | Drug Testing Laboratory, Chennai-6 | Sep 2026 |
| Absorbent cotton Gauze IS 758 | 49 | Aanand Products | Mass, Length and Width | DTL, Chennai-06 | Aug 2026 |
| Absorbent cotton IS 16468 | COT06 | Raja Surgicals | Surface active substances, Neps , Sinking time , sulphated Ash | DTL, Chennai-06 | Aug 2026 |
| Absorbent Cotton Wool I.P. 500g | R/0500/274 | Mohini Health & Hygiene Ltd, Madhya Pradesh | Neps | DTL, Chennai-06 | Aug 2026 |
| Absorbent Cotton wool IP | 2118 | Jind Surgicals, Haryana | Description, Fluorescence, Neps Sulphated Ash | DTL, Chennai-06 | Aug 2026 |
| Absorbent Cotton Wool IP | 433 | Siva Sivani Surgical Cottons(P) Ltd | The sample does not conform to I.P. with respect to Surface active substances and water soluble substances. | CDL, Kolkata | Aug 2026 |
| Absorbent Cotton Wool IP | 568 | United Cotton, Rajasthan | Neps Sulphated Ash | DTL, Chennai-06 | Aug 2026 |
| Absorbent Cotton Wool IP | R/0500/72 | Mohini Health & Hygiene Ltd, Madhya Pradesh | Neps | DTL, Chennai-06 | Aug 2026 |
| Absorbent Cotton Wool IP | 3284 | SJD Surgicot Pvt. Ltd | Water-holding capacity, Surface active substances, Fluorescence, Neps and Sulphated Ash | DTL, Chennai-06 | Aug 2026 |
| Absorbent Cotton wool IP 500gm (NOT STERILISED) 500g | 3265 | SJD Surgicot Pvt. Ltd | Water-holding capacity Fluorescence, Neps Water-soluble substances and Sulphated Ash | DTL, Chennai-06 | Aug 2026 |
| Absorbent Cotton wool IP 500gm (NOT STERILISED) 500g | 3263 | SJD Surgicot Pvt. Ltd | Water-holding capacity fluorescence, Neps , water-soluble substances and Sulphated Ash . | DTL, Chennai-06 | Aug 2026 |
| Rolled Bandage | AE-RB6-10-2K25-03 | Arunachala Enterprises, Andhra Pradesh | The sample does not conform to Schedule F(II) with respect to length. | CDL, Kolkata | Aug 2026 |
| Disposable Syringe for Single Use Only (STERILIFE) 2ml | 052502GX01 | Sterisafe Health Solutions | The sample does not comply as per IP 2022 with respect to the test for Sterility. | RDTL Guwahati | Jul 2026 |
| Handloom Rolled Bandages | 024 | Kota Saree Avam Hath kargha Vastra Utpadak Kray-Vikray Sahakari Samiti Ltd | The sample does not conform to claim as per Schedule F-(II) with respect to test for Fluorescence | CDL, Kolkata | Jul 2026 |
| Roller Bandage Non Sterilized | RC13 | Mohan Pharma B-5/2, Telangana | The Sample Does not conform to schedule F-II with respect to Description, Threads per dm (Warp) Length & Width. | DCL, Telangana | Jul 2026 |
| Disposable Syringe For Single Use Only | 052502GX01 | Sterisafe Health Solutions | The sample does not comply as per IP 2022 with respect to the test for Sterility. | RDTL, Guwahati | Jun 2026 |
| Absorbent Cotton Wool I.P. | C-111 | Vinayak Manutrade (P) Ltd, Rajasthan | The sample does not conform to IP with respect to test for 'Water soluble substances | CDL, Kolkata | May 2026 |
| Absorbent Cotton Wool I.P. | C-115 | Vinayak Manutrade (P) Ltd, Rajasthan | The sample does not conform to IP with respect to test for Water soluble substances and Sulphated ash | CDL, Kolkata | May 2026 |
| Absorbent Cotton Wool IP | COT100-08-2K25-11 | Selemp Pharma Enterprises, Andhra Pradesh | The sample does not conform to I.P. with respect to fluorescence and water soluble substances | CDL, Kolkata | May 2026 |
| Absorbent Gauze IS 758 | 177 | Sri Vishnuram Company 759/15, Tamil Nadu | Sample does not meets Length, Width, and weight in gm / sq met as per IS 758. | State Lab, DCL, Telangana | May 2026 |
| Cotton Bandage (Non Sterile) | 943 | Sapna Bunkar Hath Kargha Sahkari Samiti Ltd.B-12(D), Rajasthan | The sample does not conform to claim as per Schedule F-(II) with respect to test for Threads per dm, Weight In Gm/sq.m, Length and Fluorescence | CDL, Kolkata | May 2026 |
| Gauze Bandage | 2 | VS Healthcare, Delhi | The sample does not conform to with respect to description, mass in gm/sq.m, absorbency, scouring loss and freedom from optical whitener. | CDL, Kolkata | May 2026 |
| INFUSION SET | IV2512068 | Primesurge International, Gujarat | The sample does not comply as per I.P. 2022 with respect to the test for Sterility. | RDTL, Guwahati | May 2026 |
| Roller Bandage cloth (Non sterile) | RBC-10/16 | Lifecare Surgicals, Andhra Pradesh | The sample does not conform to the Schedule F(II) with respect to threads per dm (weft), length and foreign matter | CDL, Kolkata | May 2026 |
| Roller Bandage cloth (Non sterile) | MD/MRBC 051 | Medicure Enterprises, Andhra Pradesh | The sample does not conform to the Schedule F(II) with respect to threads per dm (warp), weight in gm/sq.m and length | CDL, Kolkata | May 2026 |
| Absorbent Cotton Wool I.P | 2085 | Jind Surgicals 24-27, Haryana | The sample is not of standard quality for the reason stated under Description | RDTL,Guwahati | Apr 2026 |
| Absorbent Cotton Wool IP | 2085 | Jind Surgicals, Haryana | The sample is not of standard quality for the reason stated under Description. | RDTL, Guwahati | Apr 2026 |
| Absorbent Gauze IS 758 | 183 | Sri Vishnuram Company 759/15, Tamil Nadu | The sample does not complies for test parameters 1. Threads per dm 2.Length 3. Width and 4.Weight In Gm/Sq.Met. | State Lab, DCL, Telangana | Apr 2026 |
| INFUSION SET | G25I020339 | Romsons Group Pvt. Ltd | The sample does not conform to manufacturer specification and ISO 8536-4 with respect to sterility. | CDL, Kolkata | Apr 2026 |
| Rolled Bandage, Schedule F (II) | 26 | Karunamoorthy Surigcals Ayyanapuram, Tamil Nadu | The sample does not complies for test parameyters1. Length 2,Width 3. Warp and 4.Weight in Grams/Sq.Met | State Lab, DCL, Telangana | Apr 2026 |
| ABSORBENT COTTON WOOL (IP) | 722 | NH Healthcare 16-E-2, Telangana | Description and Neps parameters | DCL,Telangana | Mar 2026 |
| Absorbent Cotton wool IP | L2401173 | Nuvo Medsurg Pvt. Ltd, Haryana | Sample fails the test 'Descriptive Part, Surface Active substances, Absorbency, Ether soluble substances, Water soluble substances, Neps, Sulphated Ash and Loss on Drying' as per IP | DTL Thiruvananthapuram | Mar 2026 |
| Absorbent Gauze | 705 | Pearsons Healthcare Products | The sample does not conform to B.P. with respect to threads per stated length, weight per unit area, absorbency, water soluble substances, starch and dextrins, fluorescence and sulphated ash. | CDL, Kolkata | Mar 2026 |
| Infusion Set- Nonvented | GIV-053 | Apex Medical Devices, Gujarat | Bacterial Endotoxins | Gujarat | Mar 2026 |
| Nuvo Absorbent Cotton Wool IP | C2501158 | Nuvo Medsurg Pvt. Ltd, Haryana | Sample fails the test 'Descriptive Part, Surface Active substances, Absorbency, Ether soluble substances, Water soluble substances, Neps, Sulphated Ash and Loss on Drying' as per IP | DTL Thiruvananthapuram | Mar 2026 |
| Absorbent Cotton Wool IP | 010 | Jindal Medicot Ltd | The sample does not conform to I.P. 2022 with respect to Sinking time, Fluorescence, Water soluble substances and Sulphated ash. | CDL, Kolkata | Feb 2026 |
| Absorbent Cotton Wool IP 500gm | 3208 | SJD Surgicot Pvt. Ltd | Sample fails the 'Descriptive Part, Fluorescence Ether soluble substances, Water soluble substances, Neps and Sulphated Ash' as per IP, as specified in the Laboratory Protocol | DTL Thiruvananthapuram | Feb 2026 |
| Silky Gold Foley Balloon Catheter (Siliconised) | 25F22 | Ribbel International Ltd. 20th Mile Jatheri Road, Haryana | The sample does not comply as per I.P. 2022 with respect to the Bacterial Endotoxins Test. | RDTL, Guwahati | Feb 2026 |
| Single use Hypodermic Needle | 455 62R | Hindustan Syringes & Medical Devices Ltd. 174, Haryana | The sample does not conform to claim with respect to test for Sterility. | CDL, Kolkata | Feb 2026 |
| Sterile Hypodermic Needles (For Single Use Only) Needle Size:0.55x25 mm (24Gx1") | 2428024NA1 | Nihal Healthcare, Himachal Pradesh | Sample fails the tests Cleanliness and Lubricant" as specified in the laboratory protocol . | DTL Thiruvananthapuram | Feb 2026 |
| I.V. Cannula with Injection Port | 4006523A | Poly Medicure Ltd, Haryana | The sample does not conform to Manufacturer specification in respect to the Test of Sterility and Flow rate. | CDL, Kolkata | Jan 2026 |
| I.V. Cannula with Injection Port and Wings | 3167422F | Poly Medicure Ltd, Haryana | The sample does not conform to Manufacturer specification in respect to the Test of Flow rate, Sterility. | CDL, Kolkata | Jan 2026 |
| I.V. Cannula with Injection Port non return valve, wing Luer Lock | G220611060 | Romsons Group Pvt. Ltd | The sample does not conform to Manufacturer specification with respect to the test for sterility. | CDL, Kolkata | Jan 2026 |
| Suction Catheter | SUBLE01 | Morrisons Lifecare Pvt Ltd, Tamil Nadu | The sample does not conforms to claim as per IS 8836:2019 with respect to test of 1st eye distance from tip. | RDTL, Chandigarh | Jan 2026 |
2025
| Product | Batch | Manufacturer | Reason | Tested by | Alert |
|---|---|---|---|---|---|
| Cotton Bandage | 940 | Sapna Bunkar Hath Kargha Sahkari Samiti Ltd, Rajasthan | The sample does not conform in respect to The Test of Threads per dm, Weight In Gm/sq.m, Foreign Matter, Fluorescence. | CDL, Kolkata | Dec 2025 |
| Cotton Bandage | 937 | Sapna Bunkar Hath Kargha Sahkari Samiti Ltd, Rajasthan | The sample does not conform to The test of weight in Gm/sq.m, threads per dm, Fluorescence, Foreign Matter | CDL, Kolkata | Dec 2025 |
| Safe Hand Gloves | SHR0306 | Nm | SURGICAL GLOVES | DTL Baddi | Dec 2025 |
| INFUSION SET-NV | KT-046 | Medivision Healthcare 84/4 Span Industrial complex.Second Floor, Gujarat | The sample does not comply as per IP 2022 & IS 12655 (Part 4): 2003 with respect to the tests for "Sterility and Packaging" of the Infusion sets. | RDTL, Guwahati | Nov 2025 |
| GREEN SAFE DELUX Infusion Set | 24050016 | Upico Medicare Pvt. Ltd, Gujarat | sample does not comply as per I.P. 2022 with respect to the test for "Sterility" | RDTL, Guwahati | Sep 2025 |
| Infusion Set-NV | KT-021 | Medivision Healthcare 84/4 Span Industrial complex.Second Floor, Gujarat | Sterility | RDTL, Guwahati | Aug 2025 |
| Infusion Set-NV | KT-021 | Medivision Healthcare, Gujarat | Sterility | Karnataka | Aug 2025 |
| Intravenous Catheter with Wings and Port Radiopaque Catheter | 24060193C | Cardiomac India (P.) Ltd. H-1/957, Rajasthan | Sterility | RDTL, Guwahati | Aug 2025 |
| Absorbent Cotton Wool IP To be Sterilized before use | 2096 | Jind Surgicals 24-27, Haryana | Test of Foreign Fibres, Sinking time | RDTL, Chandigarh | Jul 2025 |
| Absorbent Cotton Wool IP To be Sterilized before use | 2079 | Jind Surgicals 24-27, Haryana | Test of Foreign Fibres | RDTL, Chandigarh | Jul 2025 |
| Infusion set-NV | KT-093 | Medivision Healthcare, Gujarat | Sterility | RDTL, Guwahati | Jul 2025 |
| Infusion Set-NV | KT-071 | Medivision Healthcare, Gujarat | Sterillity | RDTL Guwahati | Jun 2025 |
| Disposable Syringes (5ml) (SUI) | 4051124S11 | Hindustan Ultra Care Limited, Rajasthan | Sterillity | RDTL, Guwahati | May 2025 |
| Infusion Set (BMD) | BIV-020 | Bhgwati Medicare Devices, Gujarat | Test for Sterility | State Lab Karnataka | Apr 2025 |
| Infusion Set (BMD) | BIV-020 | Bhagwati Medicare Devices, Gujarat | Sterility | RDTL, Guwahati | Mar 2025 |
| Insulin Syringe (U-40 Insulin 1ml Syringe) (Mr. INJECT) | 123338 | Biomed Healthcare Products Pvt. Ltd, Uttarakhand | Sterility | RDTL, Guwahati | Mar 2025 |
| HYPODERMIC SYRINGE WITH NEEDLE (Nusafe 2ml) | 2407154 | Nubeno Healthcare Private Limited, Maharashtra | Sterility | RDTL Guwahati | Jan 2025 |
2024
| Product | Batch | Manufacturer | Reason | Tested by | Alert |
|---|---|---|---|---|---|
| Absorbent Cotton Wool IP | 331 | Vandana Surgi Pharma (P) Ltd | Acidity or alkalinity, Absorbency Sinking Time, Absorbency Water-holding Capacity, Foreign Fibres, Fluorescence, Water soluble substances, Neps and Sulphated ash | CDL Kolkata | Dec 2024 |
| INFUSION SET- NV (INFUSION SET - NV) | KT-033 | Medivision Healthcare, Gujarat | Sterility | RDTL Guwahati | Dec 2024 |
| INFUSION SET | 50FC670 | Omex Medical Technology, Gujarat | Sterility | RDTL Guwahati | Nov 2024 |
| Absorbent Cotton Wool IP | 2013 | Jind Surgicals 24-27, Haryana | Surface active Substances, Sulphated ash, Fluorescence, Water Soluble Substances | CDL Kolkata | Oct 2024 |
| Single use Syringe (EDGEX) | 5DSB27 | Noble Pharmacare Ltd, Odisha | Cleanliness and Design of Piston/Plunger assembly | RDTL Chandigarh | Oct 2024 |
| INFUSION SET-NV | KT-015 | Medivision Healthcare, Gujarat | Sterility | RDTL Guwahati | Aug 2024 |
| Rolled Gauze (Non- Sterilized) | RG-006 | Blazon India, Bihar | Width, Absorbency, Scouring Loss, Freedom from Optical Whitener, Mass, Length | CDL Kolkata | Aug 2024 |
| Surgical Tape (JMS Medi-Tape 300) | 2022006 | JMS Co. Ltd | Length | CDL Kolkata | Jan 2024 |
| Surgical Tape (JMS Medi-Tape 310) | 2022003 | JMS Co. Ltd | Length | CDL Kolkata | Jan 2024 |
| Surgical Tape (JMS Medi-Tape 320) | 2022004 | JMS Co. Ltd | Length | CDL Kolkata | Jan 2024 |
| Surgical Tape (JMS Medi-Tape 330) | 2022004 | JMS Co. Ltd | Length | CDL Kolkata | Jan 2024 |
2023
| Product | Batch | Manufacturer | Reason | Tested by | Alert |
|---|---|---|---|---|---|
| The auto disable syringe (KOJAK SELINGE) | 312053KJ M1 | Hindustan Syringes & Medical Devices Ltd, Haryana | Design (Piston/Plunger Assembly) Fit of piston in barrel | RDTL Chandigarh | Aug 2023 |
| Absorbent Cotton Wool I.P. | 636 | Jajoo Surgicals Pvt. Ltd | Surface Active Substances, Sinking Time & Sulphated ash | CDTL Kolkata | Mar 2023 |
| Rolled Bandage (Non Sterilized, Size 15cm x 4 mts.) | 637 | Disha Surgicals Pvt. Ltd, Uttar Pradesh | Threads per dm (Warp & Weft), Weight in gm per m2 & Fluorescence | CDTL Kolkata | Mar 2023 |
| ABSORBENT COTTON WOOL I.P. | 1786 | Om Surgical Industries, Haryana | NEPS | RDTL Guwahati | Jan 2023 |
| Adhesive Tape USP (Micropore Surgical Tape) | R03200508 | Centurion Remedies Pvt. Ltd, Gujarat | Tensile strength per 2.54 cm of width | RDTL Chandigarh | Jan 2023 |
2022
| Product | Batch | Manufacturer | Reason | Tested by | Alert |
|---|---|---|---|---|---|
| ABSORBENT COTTON WOOL I.P., 100Gms. | 1857 | OM Surgical Industries V.&P.O. Titoli, Haryana | Neps | RDTL Guwahati | Nov 2022 |
| KINGCATH (Nelaton Catheter / Urethral Catheter) | UNBHC01 | Morisons Lifecare Pvt. Ltd, Tamil Nadu | Effective length of the catheter, overall length of the catheter and Effective shaft length of the catheter | CDL Kolkata | Oct 2022 |
| (PRICON) Sterile Single Use Hypodermic Needle | 38GB0621070 | Iscon Surgicals Ltd, Rajasthan | Sterility | RDTL Guwahati | Aug 2022 |
| Cotton Gauze Absorbent (Non- Sterilized) | G-022 | Durga Surgical Corporation, Delhi | Width | CDL Kolkata | Aug 2022 |
| Rolled Bandage | A104 | Anamika Udyog, Uttar Pradesh | Test for Threads per dm, Length, Width, Weight in gm/m2, Foreign Matter & Fluorescence | CDL Kolkata | Jun 2022 |
| Intravenous Infusion Set | 201061 | Lars Medicare Private Limited, Haryana | Description, kinking of the tubing & Leakage Test | RDTL Guwahati | Mar 2022 |
| Queencath (Female Catheter, Size 12 fr) | UCCGL01 | Morrisons Lifecare Pvt Ltd, Tamil Nadu | Sterility | CDL Kolkata | Mar 2022 |
| Rolled Bandage | A116 | Anamika Udyog, Uttar Pradesh | Threads per dm, Weight in (gm/m2), Foreign Matter, Fluorescence | CDL Kolkata | Mar 2022 |
| Hypodermic Syringe 2 ml | 19556 | Gurumangalam International, Gujarat | Description & Sterility | RDTL Guwahati | Feb 2022 |
| Hypodermic Syringe 2 ml | 19554 | Gurumangalam International, Gujarat | Description & Sterility | RDTL Guwahati | Feb 2022 |
| Intravenous Infusion Set | 201047 | Lars Medicare Private Limited, Haryana | Kinking of the tubing | RDTL Guwahati | Feb 2022 |
2021
| Product | Batch | Manufacturer | Reason | Tested by | Alert |
|---|---|---|---|---|---|
| Absorbent Cotton Wool I.P. | 172 | Doctor Surgical Works, Haryana | Surface Active Substances, Fluorescence, Sulphated Ash, Water Soluble substances and Neps | CDL Kolkata | Oct 2021 |
| Absorbent Cotton Wool I.P. (ALTUS) | A/2105 | Altus Surgical Pvt. Ltd, Gujarat | Surface Active Substances, Sulphated Ash, Water Soluble substances and Neps | CDL Kolkata | Oct 2021 |
| Infusion Set | 060220 | R. R. Medicare Products, Jammu & Kashmir | Sterility | RDTL Guwahati | Oct 2021 |
| Infusion Set | 50220 | R. R. Medicare Products, Jammu & Kashmir | Sterility & Bacterial Endotoxin | RDTL Guwahati | Oct 2021 |
| Sterile Hypodermic Syringe (2ml) | 19502 | Gurumangalam International, Gujarat | Sterility | RDTL Guwahati | Oct 2021 |
| Sterile Hypodermic Syringe (2ml) | 19507 | Gurumangalam International, Gujarat | Sterility | RDTL Guwahati | Oct 2021 |
| Sterile Hypodermic Syringe (2ml) | 19532 | Gurumangalam International, Gujarat | Sterility | RDTL Guwahati | Oct 2021 |
| Sterile Hypodermic Syringe 05 ML/CC | 19718 | Gurumangalam International, Gujarat | Sterility & Bacterial Endotoxin | RDTL Guwahati | Oct 2021 |
| Sterile Hypodermic Syringe 5 ml | 19719 | Gurumangalam International, Gujarat | Sterility | RDTL Guwahati | Oct 2021 |
| Combine Dressing Pad B.P. -1980 | ALI2163AC | Celon Laboratories Pvt. Ltd, Telangana | Sterility | CDL Kolkata | Sep 2021 |
| I.V. Cannula with Wings & Injection Port | 1081909 | Bio-Med Healthcare Products Pvt. Ltd, Uttarakhand | Sterility Test | RDTL Guwahati | Sep 2021 |
| Sterile Hypodermic Syringe 5ml | 19704 | Gurumangalam International, Gujarat | Sterility Test | RDTL Guwahati | Sep 2021 |
| Sterile Hypodermic Syringe 5ml | 19709 | Gurumangalam International, Gujarat | Sterility Test | RDTL Guwahati | Sep 2021 |
| Sterile Hypodermic Syringe 5ml | 19717 | Gurumangalam International, Gujarat | Sterility Test | RDTL Guwahati | Sep 2021 |
| Sterile Hypodermic Syringe 5ml | 19702 | Gurumangalam International, Gujarat | Sterility Test | RDTL Guwahati | Sep 2021 |
| Absorbent Cotton Wool I.P. | C150520 | Shanti Surgicals Pvt. Ltd, Uttar Pradesh | Sulphated Ash | CDL Kolkata | Aug 2021 |
| Absorbent Gauze | 09 | Sri Sanjeevi Natchiyar Surgicals | Weight in gm / m2, Length, Width, Foreign Matter and Flourescence | CDL Kolkata | Jul 2021 |
| INSTANT STERILE MOPPING PAD (Absorbent Gauze- BP Type 13 with X-Ray Detectable Thread) | 1017/20 | The Ramaraju Surgical Cotton Mills Ltd, Tamil Nadu | Threads per stated length | CDL Kolkata | Apr 2021 |
| Combine Dressing Pad B.P. 1980 | CD012 | Modern Healthcare, Tamil Nadu | Sterility | CDL Kolkata | Mar 2021 |
| Operation Theatre Gauze (Gauze Swabs B.P. 80) | 8 | Anand Product, Tamil Nadu | (Warp) Threads per 10 cm | CDL Kolkata | Mar 2021 |
| Surgicom (Cotton Gauze Pad) (Absorbent Gauze ? BP Type 13 Absorbent Cotton Wool IP) | 1023/20 | The Ramaraju Surgical Cotton Mills Ltd, Tamil Nadu | Threads per stated length for the absorbent cotton gauze (13 light) | CDL Kolkata | Mar 2021 |
2020
| Product | Batch | Manufacturer | Reason | Tested by | Alert |
|---|---|---|---|---|---|
| Hypodermic Syringe 2ml. | 19501 | Gurumangalam International | Sterility | RDTL Guwahati | Aug 2020 |
| Hypodermic Syringe 2ml. | 19503 | Gurumangalam International | Sterility | RDTL Guwahati | Aug 2020 |
| Hypodermic Syringe 5ml. | 19703 | Gurumangalam International | Sterility | RDTL Guwahati | Aug 2020 |
| Gauze Swabs B.P. :88: Type 17 | 1907225 | Premier Enterprises | Threads per stated Length and Wt. per Unit Area | CDL Kolkata | May 2020 |
| ROSE MED (Sterile Surgical Gloves Pre Powdered) | 1904A/02 | Mariya Healthcare Pvt. Ltd, Kerala | Sterility | CDL Kolkata | Apr 2020 |
| Absorbent Cotton Wool I.P., | A/1812 | Altus Surgical Pvt. Ltd, Gujarat | Water Soluble Substances and Sulphated Ash Content | CDL Kolkata | Jan 2020 |
| Dressipad (1 Surgical Dressing 10cm. X 10cm.) | KSCD-29 | K.S. Surgical Pvt. Ltd | Sterility test | RDTL Guwahati | Jan 2020 |
| Dressipad (1 Surgical Dressing 10cm. X 10cm.) | KSCD-12 | K.S. Surgical Pvt. Ltd | Sterility test | RDTL Guwahati | Jan 2020 |
2019
| Product | Batch | Manufacturer | Reason | Tested by | Alert |
|---|---|---|---|---|---|
| CREPE BANDAGE (10 CMS X 4 MTRS) | 37 | Hindustan Surgical Appliances, West Bengal | Water-soluble and Ether- soluble substances | CDL Kolkata | Nov 2019 |
| Absorbent Gauze Sch. F(II) | 83 | K. Ramakrishnan & Sons, Tamil Nadu | Weight in g/m2 | CDSCO, SubZone Goa | Feb 2019 |
| Sterile Disposable Syringe With Hypodermic Needle | 21702S1117 | SRS Meditech Ltd, Uttar Pradesh | Sterility, BET, Acidity/Alkalinity, & Light Absorption | RDTL Guwahati | Jan 2019 |
Sources
- CDSCO: Alerts table (device alerts and recalls)RegulatorCentral Drugs Standard Control Organisation
- Medical Devices Rules, 2017 and related notificationsGazetteMinistry of Health and Family Welfare
- CDSCO: Not of Standard Quality (NSQ) drug alerts, public portalRegulatorCentral Drugs Standard Control Organisation