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 |
|---|---|---|---|---|
| Nov 25, 2020 | RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323... | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... | Class II | Biomet, Inc. |
| Nov 25, 2020 | Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation. | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... | Class II | Biomet, Inc. |
| Nov 25, 2020 | 6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0,... | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... | Class II | Biomet, Inc. |
| Nov 25, 2020 | RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 1035... | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... | Class II | Biomet, Inc. |
| Nov 25, 2020 | 4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0,... | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... | Class II | Biomet, Inc. |
| Nov 25, 2020 | Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 1... | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... | Class II | Biomet, Inc. |
| Nov 25, 2020 | RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Pro... | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... | Class II | Biomet, Inc. |
| Nov 25, 2020 | OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended... | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... | Class II | Biomet, Inc. |
| Nov 25, 2020 | M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in ... | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... | Class II | Biomet, Inc. |
| Nov 25, 2020 | PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 1... | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... | Class II | Biomet, Inc. |
| Nov 25, 2020 | Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-1... | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... | Class II | Biomet, Inc. |
| Nov 25, 2020 | Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: ... | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... | Class II | Biomet, Inc. |
| Nov 25, 2020 | Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product U... | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... | Class II | Biomet, Inc. |
| Nov 25, 2020 | Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item ... | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... | Class II | Biomet, Inc. |
| Nov 25, 2020 | 3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5... | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... | Class II | Biomet, Inc. |
| Nov 10, 2020 | CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a ... | On November 10, 2020, it was discovered that there are post- processing microbial culture test fa... | Class II | CryoLife, Inc. |
| Nov 10, 2020 | CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a ti... | On November 10, 2020, it was discovered that there are post- processing microbial culture test fa... | Class II | CryoLife, Inc. |
| Nov 2, 2020 | Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures ... | Manufacturing packaging error. | Class II | Smith & Nephew, Inc. |
| Oct 23, 2020 | PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm | The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a cus... | Class II | Ethicon, Inc. |
| Sep 9, 2020 | TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Num... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Numbe... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Nu... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product N... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Numb... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Num... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 7... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Num... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product N... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Numb... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Num... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Numb... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Num... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product N... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991 | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Numb... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Nu... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Num... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702 | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product N... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product ... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product ... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Num... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product ... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Num... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Num... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Nu... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Numbe... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 721... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, 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.