Browse Device Recalls
3,419 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,419 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 3,419 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 29, 2012 | Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD... | Risk of Alkalosis with acetate containing dialysis acid concentrates | Class I | Fresenius Medical Care Holdings, Inc. |
| Mar 12, 2012 | DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpie... | Product may have wrong large product identification label with symbols on the box indicating a S9... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Dec 30, 2011 | KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods a... | One of the rods in each of two test constructs did not meet fatigue requirement as outlined in AS... | Class II | SpineFrontier, Inc. |
| Dec 23, 2011 | SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Inte... | It has been verified through field use that there are two possible breakages that may occur when ... | Class II | SpineFrontier, Inc. |
| Oct 19, 2011 | Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribu... | When the system is switched off or when the tube arm is parked in the down position (X-ray genera... | Class II | Philips Healthcare Inc. |
| Jul 5, 2011 | Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Ge... | Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Estheti... | Class II | Keystone Dental Inc |
| Jul 5, 2011 | Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 ... | Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Estheti... | Class II | Keystone Dental Inc |
| Jun 13, 2011 | Z-800 Volumetric Infusion System. For intravenous infusion of parenteral f... | Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer so... | Class II | Zyno Medical LLC |
| Mar 1, 2011 | Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Us... | Defect in the luer connector can compromise the seal on the female side of the connector and the ... | Class II | Terumo Cardiovascular Systems Corp |
| Mar 1, 2011 | Terumo Cardioplegia Delivery Set- Item Number: 16130 Produc... | Defect in the luer connector can compromise the seal on the female side of the connector. and the... | Class II | Terumo Cardiovascular Systems Corp |
| Mar 1, 2011 | Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kit... | Defect in the luer connector can compromise the seal on the female side of the connector and the ... | Class II | Terumo Cardiovascular Systems Corp |
| Mar 1, 2011 | Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypa... | Defect in the luer connector can compromise the seal on the female side of the connector and the ... | Class II | Terumo Cardiovascular Systems Corp |
| Mar 1, 2011 | Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 ... | Defect in the luer connector can compromise the seal on the female side of the connector. and the... | Class II | Terumo Cardiovascular Systems Corp |
| Mar 1, 2011 | Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog N... | Defect in the luer connector can compromise the seal on the female side of the connector. and the... | Class II | Terumo Cardiovascular Systems Corp |
| Jan 17, 2011 | Automated Impella Controller (AIC) with the below product descriptions and co... | Retrospective submission for following issues identified: 1. Alarm failures, power-path faults,... | Class I | Abiomed, Inc. |
| Dec 17, 2010 | M3150 Information Center Local Database; Models: 862249, 865001, 865003, 8650... | Potential for early component failure. | Class II | Philips Electronics North America Corporation |
| Oct 12, 2010 | Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: ... | Software Version 3.1.1 does not meet navigational accuracy. | Class II | Medtronic Navigation, Inc. |
| Apr 5, 2010 | Philips Healthcare Computed Tomography X-Ray System. These devices are who... | Philips Healthcare discovered the customer was performing CTDI measurements for facility accredi... | Class II | Philips Healthcare Inc. |
| May 10, 2008 | Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to p... | During two separate occasions an impactor plate on the handle broke off while being struck by a m... | Class II | SpineFrontier, Inc. |
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.