Browse Device Recalls

2,549 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,549 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 2,549 FDA device recalls in IN.

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DateProductReasonClassFirm
Nov 29, 2017 LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT ... The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... Class II Zimmer Biomet, Inc.
Nov 29, 2017 CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM CO... The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... Class II Zimmer Biomet, Inc.
Nov 29, 2017 BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicate... The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... Class II Zimmer Biomet, Inc.
Nov 29, 2017 FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/... The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... Class II Zimmer Biomet, Inc.
Nov 29, 2017 LPS-FLEX GSF OPT SZ C-L¿ LPS-FLEX GSF OPT SZ C-R¿ LPS-FLEX GSF OPT SZ D-L¿ ... The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... Class II Zimmer Biomet, Inc.
Nov 29, 2017 CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D... The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... Class II Zimmer Biomet, Inc.
Nov 29, 2017 Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 4... Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle. Class II Zimmer Biomet, Inc.
Nov 29, 2017 LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEM... The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... Class II Zimmer Biomet, Inc.
Nov 29, 2017 CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP ... The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... Class II Zimmer Biomet, Inc.
Nov 29, 2017 LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-R... The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... Class II Zimmer Biomet, Inc.
Nov 29, 2017 VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, H... The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... Class II Zimmer Biomet, Inc.
Nov 29, 2017 CPT 12/14 COCR SIZE 0 STD prosthesis, hip, semi-constrained, metal/polyme... The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... Class II Zimmer Biomet, Inc.
Nov 28, 2017 The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemen... The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was i... Class II DePuy Orthopaedics, Inc.
Oct 25, 2017 fastener, fixation, nondegradable, soft tissue It was identified that the product was not assembled correctly causing the implant shaft to shift... Class II Zimmer Biomet, Inc.
Oct 25, 2017 A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Numbe... The drill guides were manufactured with the incorrect color anodization. Class II Zimmer Biomet, Inc.
Oct 24, 2017 Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty ... Zimmer Biomet is conducting a medical device recall for the Persona Partial Knee Spacer Blocks in... Class II Zimmer Biomet, Inc.
Oct 19, 2017 Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the ... Cook has identified that the affected lots may contain wire guides that were loaded backwards int... Class II Cook Inc.
Oct 19, 2017 Percutaneous Gastrojejunostomy Set Product Usage: Intended for the perc... Cook has identified that the affected lots may contain wire guides that were loaded backwards int... Class II Cook Inc.
Oct 19, 2017 Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Inte... Cook has identified that the affected lots may contain wire guides that were loaded backwards int... Class II Cook Inc.
Oct 13, 2017 Newton Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Rosen Curved Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 TFE Coated Curved Newton LLT Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Fixed Core Bentson Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Disposable Reuter Tip Deflecting Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Bentson Plus Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Fixed Core Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Central Venous Catheter Tray Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Amplatz Extra Stiff Whisker Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Bentson Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Left Atrial Catheter Set Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Double Flexible Tipped Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Amplatz Stiff Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Reuter Tip Deflecting Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Femoral Artery Pressure Monitoring Set Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Bentson Cerebral Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Amplatz Ultra Stiff Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Amplatz Extra Stiff Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Movable Core Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Coons Interventional Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 11, 2017 TunneLoc Tibial Fixation Device Product Usage: To provide fixation of sof... Gamma sterilization validation testing indicates the sterilization dose for the product may not b... Class II Zimmer Biomet, Inc.
Oct 11, 2017 TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To pro... Gamma sterilization validation testing indicates the sterilization dose for the product may not b... Class II Zimmer Biomet, Inc.
Oct 3, 2017 Flexible Shaft hip and anatomical shoulder instrument used for preparation of... The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the s... Class II Zimmer Biomet, Inc.
Oct 3, 2017 Sirus Drill 13mm diameter trauma instrument used for preparation of bone in T... The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the s... Class II Zimmer Biomet, Inc.
Oct 3, 2017 Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arth... The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70... Class II Zimmer Biomet, Inc.
Sep 29, 2017 Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Numb... Knee implant components (tibial bearings) are labeled with the incorrect size. Class II Zimmer Biomet, Inc.
Sep 29, 2017 Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, It... Knee implant components (tibial bearings) are labeled with the incorrect size. Class II Zimmer Biomet, Inc.
Sep 15, 2017 36MM COCR MODULAR HD -6MM One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset ins... Class II Zimmer Biomet, Inc.
Sep 13, 2017 Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa, Model#14-... Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion o... Class II Zimmer Biomet, Inc.
Sep 13, 2017 979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument. Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion o... Class II Zimmer Biomet, Inc.
Sep 13, 2017 14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion o... Class II Zimmer Biomet, 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.