Browse Device Recalls

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

Clear
DateProductReasonClassFirm
Oct 16, 2012 bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument s... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument so... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument so... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument softw... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 4, 2012 Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a met... The color code on label conflicts with the liner size (liner size 24 should be green, not yellow) Class II Biomet, Inc.
Oct 3, 2012 STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validat... Advanced Sterilization Products (ASP) is recalling all lots of Sterrad Cyclesure 24 Biological In... Class II Advanced Sterilization Products
Oct 2, 2012 Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Commun... GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the... Class II GE Healthcare It
Sep 28, 2012 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the ac... A product complaint was received where a size 20 screw was labeled as size 30. After receipt, mea... Class II Encore Medical, Lp
Sep 26, 2012 DeGotzen XRay unit XGenus Dental X-ray unit. It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certi... Class II DeGotzen
Sep 20, 2012 STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are... Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it... Class II Advanced Sterilization Products
Sep 19, 2012 Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is d... The firm initiated the product recall because labeling on some of the intermediate boxes of cathe... Class II Cure Medical LLC
Sep 11, 2012 Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 P... Philips was notified that when performing post processing with the Brilliance Workspace Portal pl... Class II Philips Medical Systems (Cleveland) Inc
Sep 7, 2012 Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped ... Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "Th... Class II Optovue Inc.
Sep 6, 2012 Sterile, single-use, disposable electrosurgical electrode holder. It connect... The wrong electrical connector pin was attached to the cord during assembly by the manufacturer. ... Class III Gynex Corporation
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 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 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.

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.