Browse Device Recalls

2,907 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,907 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 2,907 FDA device recalls in 2015.

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DateProductReasonClassFirm
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600125911, REF/Catalog No. 600... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, 3V MANIFOLD KIT, UPN H965601011621, REF/Catalog No. 60... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, ANGIO KIT, UPN H749601319961, REF/Catalog No. 60131996... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H749600329421, REF/Catalog No. 60032942, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601605351, REF/Catalog No. 601... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600618011, REF/Catalog No. 600... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601506721, REF/Catalog No. 601... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H7496005216131, REF/Catalog No. 600521613, STERILE... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT/RIGHT HEART KIT, UPN H7496008010201, REF/Catalog ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, PTCA KIT, UPN H9656019110161, REF/Catalog No. 60191101... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART, UPN H7496006044121, REF/Catalog No. 600604... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component. Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetab... Class II Biomet, Inc.
Jan 9, 2015 NAMIC Convenience Kit, UPN H965601955411, REF/Catalog No. 60195541, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H749606204751, REF/Catalog No. 60620475, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601617931, REF/Catalog No. 601... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H965607011741, REF/Catalog No. 60701174, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H749601827221, REF/Catalog No. 60182722, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602322341, REF/Catalog No. 602... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, ANGIO DOUBLE SPIKE KIT, UPN H9656003028111, REF/Catalo... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H749600203741, REF/Catalog No. 60020374, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H7496016046121, REF/Catalog No. 601604612, STERILE... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, 5 VALVE MANIFOLD KIT, UPN H749600105121, REF/Catalog N... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, MOBILE CATH LAB KIT, UPN H749600419211, REF/Catalog No... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496007057101, REF/Catalog No. 60... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H7496013148131, REF/Catalog No. 601314813, STERILE... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H749602001451, REF/Catalog No. 60200145, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H749601308341, REF/Catalog No. 60130834, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, 3V WMMII KIT, UPN H965601852521, REF/Catalog No. 60185... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, 3 VALVE KIT CARDIOVASCULAR PROCEDURE KIT, UPN H7496004... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H749602301481, REF/Catalog No. 60230148, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial ... Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the inco... Class III Arrow International Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602207461, REF/Catalog No. 602... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable de... Current labeling indicates that cycling improves device longevity in every programming scenario. ... Class II Medtronic Neuromodulation
Jan 9, 2015 Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis co... Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetab... Class II Biomet, Inc.
Jan 9, 2015 Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only,... Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; T... Class II Teleflex Medical
Jan 9, 2015 NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749600617521, REF/Catalog No. 6006... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600407061, REF/Catalog No. 600... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H965601931651, REF/Catalog No. 60193165, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H749601904231, REF/Catalog No. 60190423, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601506921, REF/Catalog No. 6015... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, RADIOLOGY KIT, UPN H7496002072111, REF/Catalog No. 600... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 600709... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 8, 2015 CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete ... Units device head descended unexpectedly Class II Carestream Health, Inc.
Jan 8, 2015 CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to pro... Units device head descended unexpectedly Class II Carestream Health, Inc.
Jan 8, 2015 Pilling Modular Verres Body/Obturator, Product Code 140880 Packaging error in which customers who ordered product code 140880 (Verres cannula for use with a... Class II Teleflex Medical
Jan 7, 2015 This correction applies to all GE Healthcare MRI systems with superconducting... At certain sites, the MRU may not be connected to the magnet. In emergency situations, a discon... Class I GE Healthcare
Jan 7, 2015 Cold Therapy Pad - cold water circulating pad, one unit per package. The pa... Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead t... Class II Cincinnati Sub-Zero Products Inc
Jan 7, 2015 Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Ada... The taper adaptor is missing from the packaging, which may result in a delay in surgery greater t... Class II Biomet, Inc.
Jan 7, 2015 System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a ... Stryker is recalling System 6 Aseptic Housing, due to a failed Continuous Bond Line Test from a h... Class II Stryker Instruments Div. of Stryker Corporation
Jan 7, 2015 Precise Digital Accelerator Intended to be used for radiation therapy trea... Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack ma... Class II Elekta, 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.