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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
Nov 28, 2012 Pinnacle Cancellous Screw Packaging: Product is housed within a polyuretha... DePuy Orthopaedics, Inc. is issuing a voluntary recall of ten lots of the Pinnacle¿ Cancellous Sc... Class II DePuy Orthopaedics, Inc.
Nov 28, 2012 ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This devi... 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 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Cu... 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 98-0019***Modified MDA Tube with MA-D20 Attachment***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 98-0048***Custom Circular ePLUS-FP***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***Arthroscopic Knotless Suture Anchor***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 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployme... 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-4605-00***Arthroscopic Suture Anchor assembly with Suture Th... 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-4601-00***1mm 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 98-0035***Custom eMax 2 Plus Motor with microMax Disconnect Sle... 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-5000-00***Threaders, Arthroscopic Suture Anchor***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 98-0042***XMax Motor with Custom Hose***Rx Only*** This devi... 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 98-0022***8 mm Coarse Headless Screw with Driver***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 COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE. The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being u... Class II Roche Molecular Systems, Inc.
Nov 28, 2012 ANSPACH***REF SP-3012-00***13 mm Drill with Depth Stop for Short Heavy Duty A... 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. The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of do... Class III Siemens Healthcare Diagnostics
Nov 28, 2012 ANSPACH***REF SP-4604-00***3mm Fluted Ball for Adjustable 25cm Mia Attachment... 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***Modified QD11 Attachment with Soft Tissue Protector***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 Mobile Diagnostic X-Ray System with Digital Panel When the operator moves an image to another view then the electronic marker might be placed at th... Class II Philips Healthcare Inc.
Nov 28, 2012 ANSPACH***REF 98-0023***Custom 5 cm Extension Bearing Sleeve***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 Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack.... Mindray has identified a software anomaly that may where, in the presence of an asystole, the Tel... Class II Mindray DS USA, Inc. d.b.a. Mindray North America
Nov 28, 2012 ANSPACH***Custom QD11 Attachment with thinner nose tube***Rx Only*** This ... 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 98-0016***eMax 2 Modified Hand Control***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 Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in th... Calibration curve activity has increased over time in the kit lots listed. Class II The Binding Site Group, Ltd.
Nov 28, 2012 ANSPACH***MA Attachment, Straight version Custom***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 BS-200 Chemistry Analyzer Designed for clinical laboratory use. An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate. Class II Mindray DS USA, Inc. d.b.a. Mindray North America
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 98-0033***Custom Autolube Food Guard***Rx Only*** This devic... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 27, 2012 Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 4... Potential to have an internal leak at the fill port of the stainless steel tip, which may necessi... Class II Arrow International Inc
Nov 27, 2012 TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, ... RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Claus... Class II Radiometer America Inc
Nov 27, 2012 Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr ... Potential to have an internal leak at the fill port of the stainless steel tip, which may necessi... Class II Arrow International Inc
Nov 27, 2012 Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR m... Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR F... Class II Siemens Healthcare Diagnostics, Inc.
Nov 27, 2012 Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syn... Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" func... Class II Siemens Medical Solutions USA, Inc
Nov 26, 2012 Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... GranuFlo Dry Acid Concentrate may show discoloration Class III Fresenius Medical Care Holdings, Inc.
Nov 26, 2012 Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... GranuFlo Dry Acid Concentrate may show discoloration Class III Fresenius Medical Care Holdings, Inc.
Nov 26, 2012 Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 i... In the course of the firm's product monitoring activities, a potential risk for patient or operat... Class II Siemens Medical Solutions USA, Inc
Nov 26, 2012 NEOBASE NON-DERIVATIZED MSMS KIT Product Number: ... Truncated V-Bottomed Microplate Wells used in assays contain defective wells. Class II Perkinelmer
Nov 26, 2012 Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag,... Surgical procedure trays are packed with pharmaceuticals for injection that may contain particula... Class II Custom Healthcare Systems, Inc.
Nov 26, 2012 Microplate, truncated V-bottomed lots included in the above listed products ... Truncated V-Bottomed Microplate Wells used in assays contain defective wells. Class II Perkinelmer
Nov 26, 2012 Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... GranuFlo Dry Acid Concentrate may show discoloration Class III Fresenius Medical Care Holdings, Inc.
Nov 26, 2012 NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Produc... Truncated V-Bottomed Microplate Wells used in assays contain defective wells. Class II Perkinelmer
Nov 26, 2012 Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... GranuFlo Dry Acid Concentrate may show discoloration Class III Fresenius Medical Care Holdings, Inc.
Nov 26, 2012 Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in... Surgical procedure trays are packed with pharmaceuticals for injection that may contain particula... Class II Custom Healthcare Systems, Inc.
Nov 26, 2012 Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca... GranuFlo Dry Acid Concentrate may show discoloration Class III Fresenius Medical Care Holdings, Inc.
Nov 26, 2012 Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... GranuFlo Dry Acid Concentrate may show discoloration Class III Fresenius Medical Care Holdings, Inc.
Nov 26, 2012 DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010 Truncated V-Bottomed Microplate Wells used in assays contain defective wells. Class II Perkinelmer
Nov 26, 2012 Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... GranuFlo Dry Acid Concentrate may show discoloration Class III Fresenius Medical Care Holdings, Inc.
Nov 26, 2012 CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the... The expected life time of the CoverStainer slide racks (CS 10330) does not meet established perfo... Class II Dako Denmark A/S
Nov 26, 2012 Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... GranuFlo Dry Acid Concentrate may show discoloration Class III Fresenius Medical Care Holdings, Inc.
Nov 26, 2012 Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... GranuFlo Dry Acid Concentrate may show discoloration Class III Fresenius Medical Care Holdings, 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.