Browse Device Recalls
3,264 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,264 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 3,264 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 16, 2019 | 2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - ... | There is a possibility that the inner cap could open when the outer cap is removed or the entire ... | Class II | Synthes, Inc. |
| Dec 16, 2019 | 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - ... | There is a possibility that the inner cap could open when the outer cap is removed or the entire ... | Class II | Synthes, Inc. |
| Dec 16, 2019 | 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - ... | There is a possibility that the inner cap could open when the outer cap is removed or the entire ... | Class II | Synthes, Inc. |
| Dec 16, 2019 | 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - ... | There is a possibility that the inner cap could open when the outer cap is removed or the entire ... | Class II | Synthes, Inc. |
| Dec 16, 2019 | 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - ... | There is a possibility that the inner cap could open when the outer cap is removed or the entire ... | Class II | Synthes, Inc. |
| Dec 2, 2019 | Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The I... | Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging. | Class II | Medela Inc |
| Nov 4, 2019 | Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product... | Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the packa... | Class II | Integra Lifesciences Sales Llc |
| Oct 24, 2019 | Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT... | Sterile packaging incomplete seals may compromise sterility of the product | Class II | Centurion Medical Products Corporation |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
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.