Browse Device Recalls
72 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 72 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 72 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 29, 2018 | Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Cathete... | Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (O... | Class II | Stryker Sustainability Solutions |
| Jan 2, 2018 | Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable D... | An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems. | Class II | Stryker Sustainability Solutions |
| Jan 2, 2018 | Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable D... | An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems. | Class II | Stryker Sustainability Solutions |
| Dec 1, 2017 | 3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL ... | 3040 compression sleeves being mislabeled as a 3010-PL compression sleeves. | Class II | Stryker Sustainability Solutions |
| Dec 6, 2016 | Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134... | A breach in the sterile packaging may have occurred resulting in potentially non-sterile product. | Class II | Stryker Sustainability Solutions |
| Dec 6, 2016 | Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ab... | A breach in the sterile packaging may have occurred resulting in potentially non-sterile product. | Class II | Stryker Sustainability Solutions |
| Nov 11, 2016 | Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endosco... | An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in ... | Class II | Stryker Sustainability Solutions |
| Oct 6, 2016 | Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophy... | The EP Catheters may be mislabeled for French size during reprocessing. | Class II | Stryker Sustainability Solutions |
| Sep 19, 2016 | Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or... | Issue with the process for detection of leaking Pressure Tourniquet Cuffs (PTC). Leaking PTC devi... | Class II | Stryker Sustainability Solutions |
| Jun 1, 2016 | AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203 | Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being... | Class I | Stryker Sustainability Solutions |
| Apr 28, 2016 | Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; ... | Mislabeled for size | Class II | Stryker Sustainability Solutions |
| Apr 4, 2016 | Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripher... | Device packaging may not be sealed. | Class II | Stryker Sustainability Solutions |
| Apr 4, 2016 | Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175 | Device packaging may not be sealed. | Class II | Stryker Sustainability Solutions |
| Dec 17, 2015 | Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Mo... | Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single p... | Class II | Stryker Sustainability Solutions |
| Nov 17, 2015 | The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pne... | Stryker Sustainability Solutions is recalling the Fuhrman Pleural & Pneumopericardial Drainage Se... | Class I | Stryker Sustainability Solutions |
| Oct 14, 2015 | SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades ... | It was reported that packaging was not properly sealed. | Class II | Stryker Sustainability Solutions |
| Jul 10, 2015 | Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel T... | Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# ... | Class II | Stryker Sustainability Solutions |
| Jun 1, 2015 | Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. I... | Stryker Sustainability Solutions is recalling Trocars because they have received reports indicati... | Class II | Stryker Sustainability Solutions |
| Jun 1, 2015 | Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR7... | Stryker Sustainability Solutions is recalling Trocars because they have received reports indicati... | Class II | Stryker Sustainability Solutions |
| Jun 1, 2015 | Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. ... | Stryker Sustainability Solutions is recalling Trocars because they have received reports indicati... | Class II | Stryker Sustainability Solutions |
| Oct 18, 2013 | Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Cat... | Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) C... | Class II | Stryker Sustainability Solutions |
| Aug 30, 2012 | STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Throm... | Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit. | Class II | Stryker Sustainability Solutions |
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.