Browse Device Recalls
1,550 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,550 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 1,550 FDA device recalls in 2012.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 28, 2012 | Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model ... | Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to s... | Class II | Philips Medical Systems (Cleveland) Inc |
| Sep 28, 2012 | Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomograp... | Incorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the E... | Class II | Philips Medical Systems (Cleveland) Inc |
| Sep 28, 2012 | VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Resear... | Potiential for a waste fluid overflow condition to accur while running decontamination cycles on ... | Class II | Ventana Medical Systems Inc |
| Sep 28, 2012 | 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #)... | ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip ... | Class II | ICU Medical, Inc. |
| Sep 28, 2012 | Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA4... | Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Ce... | Class II | Biomet 3i, LLC |
| Sep 28, 2012 | VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Resear... | Potential for a waste fluid overflow condition to accur while running decontamination cycles on t... | Class II | Ventana Medical Systems Inc |
| Sep 28, 2012 | Segmented Cervix Applicator Set, part number GM11004310, a component used wit... | The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect fr... | Class II | Varian Medical Systems, Inc. |
| Sep 27, 2012 | VACUETTE Cellestis 1 ml QuantiFERON¿ - TB ANTIGEN; Shake 10x; REF 454074; HE0... | Cellestis is recalling QuantiFERON¿¿ - TB Gold TB Blood Collection Tubes and HA TB Blood Collecti... | Class II | Cellestis Inc |
| Sep 27, 2012 | Vacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGEN (HA) High Altitude: Shake 10x... | Cellestis is recalling QuantiFERON¿¿ - TB Gold TB Blood Collection Tubes and HA TB Blood Collecti... | Class II | Cellestis Inc |
| Sep 26, 2012 | GE Healthcare Definium 5000/5220493-2 X-Ray System | When quickly switching the protocols from AEC to Fixed under the same view, if the user selection... | Class II | GE Healthcare, LLC |
| Sep 26, 2012 | ***This recall is being conducted due to an incomplete recall for RES 57829**... | This recall is the same issue for the FDA processed recall initiated by Moog Medical Devices on 1... | Class II | MOOG Medical Devices Group |
| Sep 26, 2012 | DeGotzen XRay unit XGenus Dental X-ray unit. | It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certi... | Class II | DeGotzen |
| Sep 26, 2012 | GE Healthcare Definium 5000 / 5220493 X-Ray System | When quickly switching the protocols from AEC to Fixed under the same view, if the user selection... | Class II | GE Healthcare, LLC |
| Sep 25, 2012 | Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The ... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The ... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The ... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | ILLlCO¿ MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation S... | The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation ... | Class II | Alphatec Spine, Inc. |
| Sep 25, 2012 | Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Telefl... | Product is being recalled due to the possibility that the tray may contain pinholes, compromising... | Class II | Teleflex Medical |
| Sep 25, 2012 | Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The ... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | (l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker F... | Stryker has become aware that there is a low likelihood of incomplete engagement of the Spring Ar... | Class II | Stryker Communications, Inc. |
| Sep 25, 2012 | Belmont Rapid Infuser, a Fluid Management System, Model FMS2000. | Leak from a saline bag caused saline to drip along the back of the Rapid infuser close to the Po... | Class II | Belmont Instrument Corporation |
| Sep 25, 2012 | Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centr... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various m... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifug... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various m... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 24, 2012 | ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. T... | An anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor... | Class II | Varian Medical Systems, Inc. Oncology Systems |
| Sep 24, 2012 | PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 20... | The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 1... | Class II | Winco Mfg., LLC |
| Sep 24, 2012 | Designer Care Cliner 6700/6704/6710 WITH CAL TB 133 UPGRADE PURCHASED JAN ... | The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 1... | Class II | Winco Mfg., LLC |
| Sep 24, 2012 | Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal Sy... | Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control m... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 24, 2012 | Cozy Comfort Premier Recliner 5580 WITH CAL TB 133 UPGRADE PURCHASED JAN 01,... | The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 1... | Class II | Winco Mfg., LLC |
| Sep 24, 2012 | Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal Sy... | Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control m... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 24, 2012 | Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal ... | Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control mo... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 24, 2012 | Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manuf... | Mindray has identified an issue with the V Series Monitor where the monitors touch screen may sto... | Class II | Mindray DS USA, Inc. d.b.a. Mindray North America |
| Sep 24, 2012 | Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog... | We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Dir... | Class II | Greatbatch Medical |
| Sep 24, 2012 | PREMIER CARE RECLINER 5570/5574 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2... | The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 1... | Class II | Winco Mfg., LLC |
| Sep 21, 2012 | Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter | Asahi became aware of a negative trend for rate of the adverse events that may be associated with... | Class II | Asahi Kasei Medical Co., Ltd., Okatomi Plant |
| Sep 21, 2012 | Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter | Asahi became aware of a negative trend for rate of the adverse events that may be associated with... | Class II | Asahi Kasei Medical Co., Ltd., Okatomi Plant |
| Sep 21, 2012 | Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter | Asahi became aware of a negative trend for rate of the adverse events that may be associated with... | Class II | Asahi Kasei Medical Co., Ltd., Okatomi Plant |
| Sep 21, 2012 | Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter | Asahi became aware of a negative trend for rate of the adverse events that may be associated with... | Class II | Asahi Kasei Medical Co., Ltd., Okatomi Plant |
| Sep 21, 2012 | NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The N... | Zimmer is initiating a lot specific recall of the NexGen¿ Stemmed Nonaugmentable Tibial Component... | Class II | Zimmer, Inc. |
| Sep 21, 2012 | Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter | Asahi became aware of a negative trend for rate of the adverse events that may be associated with... | Class II | Asahi Kasei Medical Co., Ltd., Okatomi Plant |
| Sep 21, 2012 | Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter | Asahi became aware of a negative trend for rate of the adverse events that may be associated with... | Class II | Asahi Kasei Medical Co., Ltd., Okatomi Plant |
| Sep 21, 2012 | Diamigo i-Phone App The Diamigo app was intended for use as an educationa... | Diamigo, a software application, was released through the i-Phone Global Store which inadvertentl... | Class II | sanofi-aventis US, Inc. |
| Sep 21, 2012 | Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter | Asahi became aware of a negative trend for rate of the adverse events that may be associated with... | Class II | Asahi Kasei Medical Co., Ltd., Okatomi Plant |
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.