Browse Device Recalls

3,505 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,505 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 3,505 FDA device recalls in MA.

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DateProductReasonClassFirm
Jan 16, 2013 Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Uni... The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for si... Class II Philips Healthcare Inc.
Jan 16, 2013 Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Nu... An inspection shows several IATDs (Installation Acceptance Test could not be located or different... Class II Philips Healthcare Inc.
Jan 16, 2013 Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 71... Installation Acceptance Test Document (IATD) non compliant with regulations IATDs (Installation A... Class II Philips Healthcare Inc.
Jan 16, 2013 Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032... An inspection of IATD (Installation Acceptance Test Document)IA SID (Source Image Distance) recor... Class II Philips Healthcare Inc.
Jan 15, 2013 DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. D... Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class II DePuy Spine, Inc.
Jan 15, 2013 DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. ... Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class II DePuy Spine, Inc.
Jan 15, 2013 DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Del... Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class II DePuy Spine, Inc.
Jan 15, 2013 DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000... Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class II DePuy Spine, Inc.
Jan 14, 2013 P10 Tobii battery box (product number 510410) Product Usage - Battery pack... Tobii ATI customers P10 external battery pack, which contains sealed lead-acid batteries, malfunc... Class II Tobii Assistive Technology, Inc.
Jan 14, 2013 Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 ... VS2+ screen may lock up and stop monitoring during patient use Class II Philips Healthcare Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH ST Product Code: GST60900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for ... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GMC51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MPD Product Code: GMD60900000 Intended for ... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH ST Product Code: GST50900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for u... Sterility of device may be compromised due to lack of packaging integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 8, 2013 SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mes... Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and... Class II Allergen Medical
Dec 20, 2012 Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035P... A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5". Class II Medisystems a NX Stage Company
Dec 20, 2012 Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB ... Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge ... Class II Medisystems a NX Stage Company
Dec 13, 2012 Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70... Values of fluoroscopy time, Air Kerma Rate and Cumulated Air Kerma may not be displayed "at the... Class II Philips Healthcare 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 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 NEOBASE NON-DERIVATIZED MSMS KIT Product Number: ... Truncated V-Bottomed Microplate Wells used in assays contain defective wells. Class II Perkinelmer
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 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.

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.