Browse Device Recalls
2,093 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,093 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 2,093 FDA device recalls in NJ.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 24, 2017 | rHead Recon Extended Stem Size 3. Orthopedic implant for replacement of the ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Recon Stem Implant 6mm Collar, Size 3. Orthopedic implant for replaceme... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Stem Implant 6mm Collar, Size 2. Orthopedic implant for replacement of ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Recon Stem Implant Plasma Coated, Size 3. Orthopedic implant for replac... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | #4 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | radial stem implant #2 (Sterile packed). Orthopedic implant for replacement ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Radio Capitellum, Recon Head, Size #3. Orthopedic implant for replacement of... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Radio Capitellum Broach Large, Right. Orthopedic implant for replacement of ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Standard Extended Stem, 6mm Collar, Size 2. Orthopedic implant for repl... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Radial Head Assy Size #4, Rad. Orthopedic implant for replacement of the prox... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | #3 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | #1 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Recon Stem Implant 6mm Collar,Size 1. Orthopedic implant for replacemen... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Radio Capitellum Large, Right. Orthopedic implant for replacement of the pro... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | #2 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Lateral Assembly, Radial Head Implant, Size 3. Orthopedic implant for replace... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Lateral Assembly, Radial Head Impl Assembly, Size 3. Orthopedic implant for r... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | radial stem implant #1 (Sterile packed). Orthopedic implant for replacement ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Recon Stem Implant Plasma Coated, Size 4. Orthopedic implant for replac... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Lateral Assembly, Radial Head Impl Assembly, Size 2. Orthopedic implant for r... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Lat Assembly, Rad Stem Implant,Collar 6mm,Size 2. Orthopedic implant for repl... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | #4 Bipolar radial head Implant (Sterile packed). Orthopedic implant for repl... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Recon Stem Implant non-coated, Size 1. Orthopedic implant for replacem... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Lateral Assembly, Radial Head Impl Assembly, Size 4. Orthopedic implant for r... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Radio Capitellum Small, Left. Orthopedic implant for replacement of the prox... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | radial stem implant #3 (Sterile packed). Orthopedic implant for replacement ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 23, 2017 | Surgical punch; sealed pouches packed in punch shelf box Intended for use... | Surgical punches are being recalled due to potential packaging damage which may have occurred dur... | Class II | Alto Development Corp |
| Oct 19, 2017 | BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 70... | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 33500 3/8" ECC PACK, Catalog No. 701053752 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 50903 Custom ECC Pack-Pedriatric , Custom Tubing Kit, Catalog No. 70... | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067... | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 22701, Catalog No. 701050790 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope 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.