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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.

Clear
DateProductReasonClassFirm
Sep 6, 2012 SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 22... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRA... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 SPIRALOK ... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single ... The Wireless Portable Detector (WPD) is not fixed securely inside the Mobile Detector Holder and ... Class II Philips Healthcare Inc.
Sep 5, 2012 Mindray DPM5 Monitor, a vital signs monitor used on human patients in health... Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not b... Class II Mindray DS USA, Inc. d.b.a. Mindray North America
Sep 5, 2012 Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers... There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, Franc... Class II Wright Medical Technology Inc
Sep 5, 2012 ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR Intended to... Zimmer is conducting a voluntary removal of some Zimmer A.T.S. 3000 tourniquets after receiving c... Class II Zimmer, Inc.
Sep 5, 2012 Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Numbe... There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, Franc... Class II Wright Medical Technology Inc
Sep 5, 2012 Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383... There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, Franc... Class II Wright Medical Technology Inc
Sep 5, 2012 Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guar... Contact between the bur and bur guard could generate metal fragments that may or may not be visi... Class II The Anspach Effort, Inc.
Sep 4, 2012 The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable,... Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimu... Class II Advanced Neuromodulation Systems Inc.
Sep 4, 2012 Anatomical Shoulder" Ball taper for humeral stem Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Zimmer Inverse/Reverse Screw system, Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 MS-30 Shaft, Sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder... Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Biolox¿ delta Ceramic Femoral Head Rx only, sterile Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Metasul¿ LDH¿ Head Rx Sterile Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Anatomical Shoulder" Fracture Humeral Head Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 MS-30¿ Proximal positioner Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 CoCr Head, sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Wagner cone Prosthesis, uncemented, sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Cod... Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" pac... Class II Davol, Inc., Subs. C. R. Bard, Inc.
Sep 4, 2012 Wagner SL Revision Stem, uncemented Sterile Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Alloclassic¿ SL-Offset Stem sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Sirus¿ intramedullary nail for tibia, cannulated ¿ Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Dynesys¿ L.I.S. Stabilizing cord Rx, Sterile Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 NCB¿-PT lateral proximal 3 hole tibial plate Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Dynesys¿ Universal spacer 6-45 Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Dynesys¿ Set screw M6 Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Metasul¿ Durom¿ Femoral component Sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 NCB¿-PH Plate Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Dynesys¿ HA Pedicle + set screw Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Fitmore" Hip Stem Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Kopf Adapter S Sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 NCB¿ cancellous screw Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Anatomical Shoulder" Humeral Head Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Original M.E. Mueller" Low Profile Cup Sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 CLS Stem Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 MS-30¿ Distal centralizer, cemented, sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Anatomical Shoulder" Humeral stem Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 MS-30¿ Stem Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Dynesys¿ Revision + set screw Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Anatomical Shoulder" Inverse/Reverse Glenoid Sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Anatomical Shoulder" Inverse Humeral Cup Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Co... Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" pa... Class II Davol, Inc., Subs. C. R. Bard, Inc.
Sep 4, 2012 zimmer Anatomical Shoulder Glenoid S, cemented, sterile; REF 01.04214.340 P... Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Biolox¿ Option Ceramic Femoral Head System Rx, sterile Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert Sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Alloclassic SL Shaft Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Anatomical Shoulder" Fracture Humeral stem Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, 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.