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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
Dec 3, 2012 SOL SYS L 9IN CALC 2.25/18 Packaging: Product is packed within a poly prot... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS L 9IN CALC 2.25/21 Packaging: Product is packed within a poly prot... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS 8IN CALC 1.5/15.0 Packaging: Product is packed within a poly prote... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly prote... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS R 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS L 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS R 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnos... Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B F... Class II Quidel Corporation
Dec 3, 2012 Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: B... Software anomalies. Philips Medical Systems recalled their Brilliance 64 running software v4.0.0x... Class II Philips Medical Systems (Cleveland) Inc
Dec 3, 2012 SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly prot... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed within a poly prot... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS F 8 CALC 13.5MM LG Packaging: Product is packed within a poly prot... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 3708... Medtronic has identified 140 Restore DBS Extension Kits (model numbers 7482, 37085, and 37086), w... Class II Medtronic Neuromodulation
Dec 3, 2012 SOL SYS L 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS 8IN CALC 1.5/19.5 Packaging: Product is packed within a poly prote... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS R 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS L 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS 8IN CALC 1.5/18.0 Packaging: Product is packed within a poly prote... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Nov 30, 2012 Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy... Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specific... Class II Biomet Spine, LLC
Nov 30, 2012 Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 371... There is issues of warmth or heating at the implant site during charging for the Eon Mini implant... Class II St. Jude Medical
Nov 29, 2012 Handset component of the Handicare USA's Minivator Bath Bliss Reclining Bath ... Firm became aware that two handsets in the affected batches became inoperable while the user was ... Class II Handicare Accessibility
Nov 29, 2012 CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381,... Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in... Class II Thermo Fisher Scientific (Asheville) LLC
Nov 28, 2012 ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intende... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0043***Custom Device eMax 2 Plus Hand Control that will work... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF SP-5001-00***20 degree Angle Driver (MA-D20) - Custom***Rx Only... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0025***Custom MDA Tube for use with MA-D20 Attachment***Rx O... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0008***7cm Medium Attachment Custom***Rx Only*** This dev... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0021***eMax2 Console with Irrigation***Rx Only*** This de... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0003***Sagittal microSaw Attachment Custom***Rx Only*** T... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF-98-0062***Custom Device eMax2 Plus Hand Control***Rx Only*** ... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0029***8 mm Coarse Threaded Headless Bone Screw***Rx Only***... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** Thi... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the Anspach Custom Devices. The u... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0044***Custom Device Speed Reducer with Bumper***Rx Only*** ... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0024***Nose Cone Cover***Rx Only*** This device is intend... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0031***Custom Medium Attachment, with 5 mm Extended Tapered ... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx On... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 Immunoradiometric assay. Device is an immunoradiometric assay designed for... The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of do... Class III Siemens Healthcare Diagnostics
Nov 28, 2012 ANSPACH***REF-98-0056***Custom Device Autolube III modified with a swivel***R... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF SP-3100-00***5mm Coarse Diamond Ball, 11.5 OAL***Rx Only*** ... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0001***eMax Hand Control***Rx Only*** This device is inte... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF SP-4602-00***2mm Coarse Diamond Ball for Adjustable 25cm Mia At... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF SP-4603-00***3mm Coarse Diamond Ball for Adjustable 25cm Mia At... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0010***2.37mm Spiral Drill, for Short Attachment (Non-Steri... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Onl... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only*** This device ... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF SP-3101-00***Adjustable 25 Cm Mia Attachment, Custom***Rx Only*... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***eMax2 Lower Profile Foot Pedal***Rx Only*** This device is inten... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry an... Due to a software data storage limitation which only occurs under certain conditions, measurement... Class II Beckman Coulter 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.