Browse Device Recalls
2,522 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,522 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 2,522 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 30, 2017 | Kit w/3 Ext Sets, 3 Drop-In MicroClave¿ Clear. Product Usage: The device is... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, N... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, ... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 N... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave¿ Manif... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotat... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 22, 2017 | Zimmer Periarticular Locking Plate System Locking Screw Tap Standard Quick-Co... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | Zimmer Periarticular Locking Plate System Cannulated Drill Standard Quick-Con... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | Zimmer Periarticular Locking Plate System Drill Standard 2.7 mm Diameter, It... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | Zimmer Periarticular Locking Plate System, Locking Screw Tap Standard Quick-C... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| May 22, 2017 | Zimmer Periarticular Locking Plate System Drill Standard 2.0 mm Diameter, Ite... | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... | Class II | Zimmer Biomet, Inc. |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pre... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag Product Usag... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, filter Prod... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, filt... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pre... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, PEEP valve ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-r... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pre... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, 28inch large bore tubing, pressu... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, PEEP... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, 40 inch oxygen reservoir tubing, pr... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-r... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-reli... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Res... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Res... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, 28inch large bore tubing Product ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, manometer,... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, 28inch large bore tubing, pressure-... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEE... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Replacement kit for outer shell, Broselow Product U... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-reli... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, 28inch large bore tubing, pressure-r... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pre... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer P... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pre... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 20, 2017 | The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surge... | The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Hea... | Class II | Acumed LLC |
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.