Browse Device Recalls
17 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 17 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 17 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 20, 2015 | Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous ... | Two isolated instances of holes in the outer header bag component of the double barrier sterile p... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Feb 26, 2015 | Vitagel; indicated in surgical procedures (other than in neurosurgical and op... | Several shipments of Vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Dec 4, 2014 | Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: ... | There is the potential for a breach in the inner or outer packaging pouches of all lots of the Im... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Dec 4, 2014 | Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Number... | There is the potential for a breach in the inner or outer packaging pouches of all lots of the St... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
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.