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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.