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
Oct 10, 2019 PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL, Item Nos. 00234801303 002348... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Periarticulare Plates - Elbow, Humeral and Ulna Plates, Item Nos. 00234800504... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 0057... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Metasul Taper Liner, various sizes, Item Nos. 00877000528 00877000628 00877... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Periarticular locking plate elbow-sterile, Item Nos. 47235800503 4723580050... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 002232... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 010029605... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 472... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 FEMOROTIBIAL/FEMORAL NAIL, various sizes. Item Nos. 32855331111 32855331113 ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 NCB Straight Narrow Plate, various sizes, Item Nos. 0202267008 0202267010 0... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 0058500... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Cephalomedullary Nail (CMN), Various sizes, Item Nos. 47249318009 4724931801... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 4723571... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 NCB-PH Plate with 4/5/7 Lock Holes, Item Nos. 0202262104 0202262105 0202262107 Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 0023470030... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 ZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 LPS-MOB ART SURF IMPL D 9MM Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various fixation systems and accessories, Item Nos. 00224000916 00224000918 ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 PROX LAT HUMERAL LOCK PLATE, Item Nos. 47235800104 47235800106 47235800108 ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various fixation systems and accessories, Item Nos. 00118100522 00118100527 ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Ceramic Femoral Heads, various sizes, Item Nos. 00877504001 00877504002 008... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various temporary devices used during the implantation of the device system: ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Metasul Femoral Heads, various sizes, Item Nos. 00877004001 00877004002 008... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos. 47235700306 ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various Knee Systems, Item Nos. 32855411838 32855411840 32855411842 328554... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106 00234700108 00234700110... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Connection Screw for NCB Plate, Item No. 0202266002 Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 004300007... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 9, 2019 Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number... Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect s... Class II Nextremity Solutions
Oct 8, 2019 Cobas infinity central lab / cobas infinity core license-a Calculator/Data Pr... Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver -... Class II Roche Diagnostics Operations, Inc.
Oct 4, 2019 Roche Homocysteine-In vitro test for the quantitative determination of total ... Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 an... Class II Roche Diagnostics Operations, Inc.
Oct 3, 2019 Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos ... Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter ... Class II Cook Inc.
Oct 3, 2019 Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embr... Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter ... Class II Cook Inc.
Sep 30, 2019 Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RE... Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. Class II Roche Diabetes Care, Inc.
Sep 30, 2019 Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE ME... Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. Class II Roche Diabetes Care, Inc.
Sep 30, 2019 Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SA... Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. Class II Roche Diabetes Care, Inc.
Sep 30, 2019 Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RE... Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. Class II Roche Diabetes Care, Inc.
Sep 30, 2019 Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HC... Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. Class II Roche Diabetes Care, Inc.
Sep 30, 2019 Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SA... Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. Class II Roche Diabetes Care, Inc.
Sep 17, 2019 Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Pr... Lidstock perforation line may be over the sterile area of the tray, when it should be on the lip ... Class II Cook Inc.
Sep 11, 2019 Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: I... Due to low Quality Control recovery and invalid Calibration. Class III Roche Diagnostics Operations, Inc.
Sep 11, 2019 Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - ... Due to low Quality Control recovery and invalid Calibration. Class III Roche Diagnostics Operations, Inc.
Aug 28, 2019 cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF i... Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Int... Class II Roche Diagnostics Operations, Inc.
Aug 28, 2019 cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay... Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Int... Class II Roche Diagnostics Operations, 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.