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.

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DateProductReasonClassFirm
Apr 12, 2012 Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. Gra... Potential for increase level of artifacts to appear as large, spherical and easy to distinguish o... Class II Becton Dickinson & Co.
Apr 12, 2012 BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and a... Potential for increase level of artifacts to appear as large, spherical and easy to distinguish o... Class II Becton Dickinson & Co.
Apr 12, 2012 Rectal Retractors, stainless steel, item # AL07289000, a component of Varian... A medical device used in brachytherapy may become contaminated and can cause infections, toxicity... Class II Varian Medical Systems, Inc.
Apr 12, 2012 Rectal Retractors, titanium, item # AL07368000, a component of Varian Medica... A medical device used in brachytherapy may become contaminated and can cause infections, toxicity... Class II Varian Medical Systems, Inc.
Apr 11, 2012 Symbia E is a multi-purpose SPECT system used to detect or image the distribu... Radial motor drives replaced during a customer service action were incorrectly assembled backwards. Class II Siemens Medical Solutions USA, Inc.
Apr 11, 2012 E.CAM emission computed tomography system used to detect or image the distrib... Radial motor drives replaced during a customer service action were incorrectly assembled backwards. Class II Siemens Medical Solutions USA, Inc.
Apr 11, 2012 AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The A... The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tube... Class II Beckman Coulter Inc.
Apr 10, 2012 The brand name of the device is Laser Loupes, a dentalloupe with laser eye ... The firm initiated the recall for Laser Loupes because the ink used to mark which laser frequency... Class II Kerr Corporation
Apr 10, 2012 "***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATE... Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cann... Class II Linvatec Corp. dba ConMed Linvatec
Apr 10, 2012 "***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVA... Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cann... Class II Linvatec Corp. dba ConMed Linvatec
Apr 10, 2012 GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-O... GE Healthcare has recently become aware of a potential safety issue due to the interlock slide me... Class I GE Healthcare, LLC
Apr 9, 2012 GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-R... The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm'... Class II Gulf Fiberoptics, Inc.
Apr 9, 2012 "***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 1... ConMed Linvatec is recalling the product due to the punch being mis-assembled with the incorrect ... Class II Linvatec Corp. dba ConMed Linvatec
Apr 6, 2012 STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a... STERIS has learned from Customer feedback and field service experience that damage from external ... Class II Steris Corporation
Apr 6, 2012 TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Mo... Invacare Corporation decided to recall the product because of a potential risk of fire and seriou... Class II Invacare Corporation
Apr 6, 2012 Etac¿ Ono Walker, Etac¿ Avant Walker, and Etac¿ Salsa Walker. These produ... The recall has been initiated because there is the potential that users may fall and become injur... Class II Etac Supply Center Ab
Apr 4, 2012 Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. In... The pouch label of catalog NL850-1330 indicates an incorrect model and closing pressure of the de... Class II Integra LifeSciences Corp
Apr 4, 2012 GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (A... GE Healthcare has become aware of a software issue on the interface of the mobile radiographic pr... Class II GE Healthcare, LLC
Apr 3, 2012 Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distribut... The lyophilized thrombin component of the Surgiflo Hemostatic Matrix kit with Thrombin has the po... Class II Ethicon, Inc.
Apr 3, 2012 Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The U... Beckman Coulter is recalling the UniCel DxH 800 Coulter Cellular Analysis System because the NRBC... Class II Beckman Coulter Inc.
Apr 2, 2012 Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Ca... Stryker Orthopaedics has become aware of a burr, or a metal shaving, observed in the internal thr... Class II Stryker Howmedica Osteonics Corp.
Apr 2, 2012 MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable... Product was packaged with the incorrect port and does not match the label. The kit is labeled as... Class II Medical Components, Inc dba MedComp
Apr 2, 2012 Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. ... : The Quickshield Complete Plus may have a defect (split at the base), which can cause the green ... Class II Greiner Bio-One North America, Inc.
Apr 2, 2012 Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birth... During review of our last braking system via that field corrective action, the system still did n... Class II Hill-Rom, Inc.
Mar 30, 2012 Model 324JL On-Board Suction System Intended use: On-board suction system f... A shipment mix-up took place. Class III Impact Instrumentation, Inc.
Mar 29, 2012 MCA5-1SB - 1MM Fluted Ball, 5.6CM. All lots are included in recall. Inten... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
Mar 29, 2012 MCA5-2SB - 2MM Fluted Ball, 5.6CM. All lots are included in recall. Inten... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
Mar 29, 2012 MCA5-08SD - 0.8MM Diamond Ball, 5.6CM. All lots are included in recall. I... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
Mar 29, 2012 MCA5-07SD - 0.7MM Diamond Ball, 5.6CM. All lots are included in recall. I... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
Mar 29, 2012 MCA5-2SD - 2MM Diamond Ball, 5.6CM. All lots are included in recall. Inte... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
Mar 29, 2012 MCA7-1SB - 1MM Fluted Ball, 7.3CM. All lots are included in recall. Inten... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
Mar 29, 2012 MCA7-08SD - 0.8MM Diamond Ball, 7.3CM. All lots are included in recall. I... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
Mar 29, 2012 MCA5-05SD - 0.5 MM Diamond Ball, 5.6CM. All lots are included in recall. ... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
Mar 29, 2012 MCA7-2SD - 2MM Diamond Ball, 7.3CM. All lots are included in recall. Inte... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
Mar 29, 2012 MCA7-05SD - 0.5MM Diamond Ball, 7.3CM. All lots are included in recall. I... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
Mar 29, 2012 MCA5-06SD - 0.6MM Diamond Ball, 5.6CM. All lots are included in recall. I... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
Mar 29, 2012 Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-... Risk of Alkalosis with acetate containing dialysis acid concentrates Class I Fresenius Medical Care Holdings, Inc.
Mar 29, 2012 MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Inte... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
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 29, 2012 MCA7-07SD - 0.7MM Diamond Ball, 7.3CM. All lots are included in recall. I... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
Mar 29, 2012 Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping del... Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details ... Class II The Anspach Effort, Inc.
Mar 29, 2012 MCA7-2SB - 2MM Fluted Ball, 7.3CM. All lots are included in recall. Inten... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
Mar 29, 2012 MCA7-06SD - 0.6MM Diamond Ball, 7.3CM. All lots are included in recall. I... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
Mar 29, 2012 MCA5-15SB - 1.5MM Fluted Ball, 5.6CM. All lots are included in recall. In... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
Mar 29, 2012 MCA5-15SD - 1.5MM Diamond Ball, 5.6CM. All lots are included in recall. I... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
Mar 29, 2012 Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are includ... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
Mar 29, 2012 MCA5-1SD - 1MM Diamond Ball, 5.6CM. All lots are included in recall. Inte... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
Mar 29, 2012 MCA7-15SD - 1.5MM Diamond Ball, 7.3CM. All lots are included in recall. I... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
Mar 29, 2012 MCA7-15SB - 1.5MM Fluted Ball, 7.3CM. All lots are included in recall. In... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
Mar 28, 2012 Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, S... St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which w... Class III St Jude Medical 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.