Browse Device Recalls
3,179 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,179 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 3,179 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Dec 17, 2019 | VitreQ 27G Blunt Needles with luer-lock connector-REF: CN27.D05 GTIN:871921... | Microscopic tears of the sterile pouch may compromise sterility | Class II | Vitreq Bv |
| Dec 17, 2019 | (1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51 GTIN: 8719214221089 (2) Vitre... | Microscopic tears of the sterile pouch may compromise sterility | Class II | Vitreq Bv |
| Dec 17, 2019 | VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461 | Microscopic tears of the sterile pouch may compromise sterility | Class II | Vitreq Bv |
| Dec 17, 2019 | VitreQ 25G Blunt Needles with luer-lock connector-REF : CN25.D05 GTIN: 8719... | Microscopic tears of the sterile pouch may compromise sterility | Class II | Vitreq Bv |
| Dec 17, 2019 | VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508 | Microscopic tears of the sterile pouch may compromise sterility | Class II | Vitreq Bv |
| Dec 17, 2019 | VitreQ 25G Pick Needles-REF: CN25.D04 GTIN: 8719214221607 | Microscopic tears of the sterile pouch may compromise sterility | Class II | Vitreq Bv |
| Dec 17, 2019 | VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386 | Microscopic tears of the sterile pouch may compromise sterility | Class II | Vitreq Bv |
| Dec 17, 2019 | (1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25... | Microscopic tears of the sterile pouch may compromise sterility | Class II | Vitreq Bv |
| Dec 17, 2019 | VitreQ 25G Silicone Tipped Cannula-REF: CN25.D01 GTIN: 8719214221522 | Microscopic tears of the sterile pouch may compromise sterility | Class II | Vitreq Bv |
| Dec 17, 2019 | VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362 | Microscopic tears of the sterile pouch may compromise sterility | Class II | Vitreq Bv |
| Dec 17, 2019 | VitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485 | Microscopic tears of the sterile pouch may compromise sterility | Class II | Vitreq Bv |
| Dec 17, 2019 | VitreQ 25G VFI Cannula-REF: CN25.D03 GTIN: 8719214221447 | Microscopic tears of the sterile pouch may compromise sterility | Class II | Vitreq Bv |
| Dec 17, 2019 | VitreQ 23G VFI Cannula-REF: CN23.D03 GTIN: 8719214221423 | Microscopic tears of the sterile pouch may compromise sterility | Class II | Vitreq Bv |
| Dec 17, 2019 | (1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23... | Microscopic tears of the sterile pouch may compromise sterility | Class II | Vitreq Bv |
| Dec 17, 2019 | VitreQ 23G Blunt Needles with luer-lock connector-REF: CN23.D05 GTIN: 8719... | Microscopic tears of the sterile pouch may compromise sterility | Class II | Vitreq Bv |
| Dec 17, 2019 | VitreQ 23G Pick Needles-REF: CN23.D04 GTIN: 8719214221584 | Microscopic tears of the sterile pouch may compromise sterility | Class II | Vitreq Bv |
| Dec 11, 2019 | Centurion-LVAD Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMEN... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2019032... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- SPEC0002B ARTHROGRAM TRAY SPEC0002B ARTHROGRAM TRAY SPEC0004C A... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion-Irrigation Kit IG25STSS IRRIGATION GUN &VALVE SET W/SPLASHSHIELD Y | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- Pathology Container 1150ST STERILE GRADUATED CONTAINER, 32 OZ. 1... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYND... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion-General Surgery Convenience Kits DYNDH1033B SUBCLAVIAN ON/OFF KIT ... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
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.