Browse Device Recalls
334 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 334 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 334 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - 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 0 30" VIOLET GU-46, Item Code UL877 - Prod... | 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 36 VIOLET GS-24, Item Code CL914 - 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 3/0 VIOLET 30" CV-24 (75CM), Item Code CL4... | 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 4/0 30 VIOLET CVF23, Item Code UL203 - 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 6/0 12"" VL SS-24 D/A, Item Code L1742K - ... | 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 30 VIOLET GS-22, Item Code CL885 - 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 30" V-20, Item Code GL323 - 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 3/0 30 VIOLET GS-11, Item Code CL815 - 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 30 VIOLET GS-21, Item Code CL811 - Pro... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201 | 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 3/0 30" UNDYED V-20, Item Code GLS322 - 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 4/0 30 VIO SC-2 124K, Item Code SL654 - 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 36" VIOLET GS-24, Item Code CL911 - Prod... | 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 30" UNDYED HOS-11, Item Code CL537 - 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 6-0 18" UNDYED SS-24 D/A, Item Code L2752K... | 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 6/0 18" UNDYED P-10, Item Code SL1625G - P... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| May 17, 2019 | EGIA45 CT AR MD THK REL, EGIA45CTAMT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | Class II | Covidien LLC |
| May 17, 2019 | EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT | The device may be missing one of two pin components that maintain alignment of the device jaws, r... | 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.