Browse Device Recalls
3,313 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,313 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 3,313 FDA device recalls in 2017.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 1, 2017 | Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethyl... | COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instr... | Class II | Cook Inc. |
| May 1, 2017 | Willscher Vas Skewers, Surgical Instrument, Supplied sterilized by ethylene o... | COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instr... | Class II | Cook Inc. |
| May 1, 2017 | XARIO 100 TUS-X100 diagnostic ultrasound system | When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace ... | Class II | Toshiba American Medical Systems Inc |
| May 1, 2017 | LapSac Introducer Set, Bag, Extraction, Supplied sterilized by ethylene oxide... | COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instr... | Class II | Cook Inc. |
| May 1, 2017 | SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in t... | Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to exhi... | Class II | Circadiance LLC |
| May 1, 2017 | Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized ... | COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instr... | Class II | Cook Inc. |
| May 1, 2017 | ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. ... | Robot arm being sent to the wrong position | Class II | Zimmer Biomet, Inc. |
| May 1, 2017 | APLIO 500 TUS-A500 diagnostic ultrasound system | When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace ... | Class II | Toshiba American Medical Systems Inc |
| May 1, 2017 | XARIO 200 TUS-X200 diagnostic ultrasound system | When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace ... | Class II | Toshiba American Medical Systems Inc |
| May 1, 2017 | LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open pac... | COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instr... | Class II | Cook Inc. |
| May 1, 2017 | Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by... | COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instr... | Class II | Cook Inc. |
| May 1, 2017 | ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. I... | Robot arm being sent to the wrong position | Class II | Zimmer Biomet, Inc. |
| Apr 28, 2017 | R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48C... | Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... | Class II | Zimmer Biomet, Inc. |
| Apr 28, 2017 | Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Cen... | Arrow International is notifying each customer who received the affected that product that the ki... | Class II | Arrow International Inc |
| Apr 28, 2017 | Monica Novii Wireless Patch System product Usage: Novii Interface - The N... | Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged cha... | Class II | MONICA HEALTHCARE LTD |
| Apr 28, 2017 | 4.5 BROAD SCP PLT 26-H STER | Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... | Class II | Zimmer Biomet, Inc. |
| Apr 28, 2017 | TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMD... | Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... | Class II | Zimmer Biomet, Inc. |
| Apr 28, 2017 | NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthr... | Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen... | Class II | Zimmer Biomet, Inc. |
| Apr 28, 2017 | 1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Pa... | Potential sterile barrier breach | Class II | KCI USA, INC. |
| Apr 28, 2017 | TI Transport Monitor/Module Battery Pack Product Usage: intended for moni... | Mindray has received two reports from outside the United States that the battery pack for TI tran... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Apr 28, 2017 | Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Scien... | Exact Sciences is correcting all Sample Mixer v2 Upgrade units because of incidents of Sample Mix... | Class II | Exact Sciences Corporation |
| Apr 28, 2017 | FEM IM NAIL 15MMDX30CM, FEM IM NAIL 16MMDX30CM FEM IM NAIL 14MMDX32CM FEM ... | Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... | Class II | Zimmer Biomet, Inc. |
| Apr 28, 2017 | VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 13... | Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... | Class II | Zimmer Biomet, Inc. |
| Apr 28, 2017 | Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L ... | Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... | Class II | Zimmer Biomet, Inc. |
| Apr 28, 2017 | VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H | Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... | Class II | Zimmer Biomet, Inc. |
| Apr 28, 2017 | FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL 13MMDX... | Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... | 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 | AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. | PEG kits have the potential for one of the following defects: missing components, duplicate compo... | Class II | AbbVie Inc. |
| 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 |
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.