Browse Device Recalls

675 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 675 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 675 FDA device recalls.

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DateProductReasonClassFirm
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" V-... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 30" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 VL 18" P-10... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Aug 3, 2020 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" ... The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a su... Class II Riverpoint Medical, LLC
Jun 26, 2020 Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-us... This voluntary recall is being conducted following three customer reports of the device cannula d... Class II Covidien Llc
Jun 26, 2020 Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-u... This voluntary recall is being conducted following three customer reports of the device cannula d... Class II Covidien Llc
May 12, 2020 Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Pro... The product is recalled due to a manufacturing assembly error that may cause the staples to fail ... Class II Covidien Llc
May 12, 2020 Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Par... The product is recalled due to a manufacturing assembly error that may cause the staples to fail ... Class II Covidien Llc
May 12, 2020 Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Par... The product is recalled due to a manufacturing assembly error that may cause the staples to fail ... Class II Covidien Llc
May 12, 2020 Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Pro... The product is recalled due to a manufacturing assembly error that may cause the staples to fail ... Class II Covidien Llc
Apr 30, 2020 Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 40... Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... Class II Covidien Llc
Apr 30, 2020 Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL F... Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... Class II Covidien Llc
Apr 30, 2020 Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley T... Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... Class II Covidien Llc
Apr 30, 2020 Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Produ... Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... Class II Covidien Llc
Apr 30, 2020 Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code:... Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... Class II Covidien Llc
Apr 30, 2020 Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Se... Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... Class II Covidien Llc
Apr 30, 2020 Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley T... Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... Class II Covidien Llc
Apr 30, 2020 Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm)... Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... Class II Covidien Llc
Apr 30, 2020 Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm),... Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... Class II Covidien Llc
Apr 30, 2020 Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400... Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... Class II Covidien Llc
Apr 30, 2020 Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Se... Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... Class II Covidien Llc
Feb 10, 2020 Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and F... Sterile packaging may potentially be compromised, and use of products may result in increased ris... Class II Covidien Llc
Feb 10, 2020 Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed ... Sterile packaging may potentially be compromised, and use of products may result in increased ris... Class II Covidien Llc
Jan 17, 2020 Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, trans... Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier ... Class II COVIDIEN LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Produ... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Produ... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Produ... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Pr... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Pr... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Pro... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL22... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC
Dec 18, 2019 Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - P... There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... Class II Covidien LLC

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.