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Browse Device Recalls

2,527 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,527 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 2,527 FDA device recalls in IN.

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DateProductReasonClassFirm
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.
Aug 21, 2019 GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usa... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 21, 2019 Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Pro... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 21, 2019 2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instru... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 21, 2019 Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 ... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 21, 2019 Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 17... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 21, 2019 Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 ... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 21, 2019 Various Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 21, 2019 HENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 21, 2019 LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMR... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 21, 2019 ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arco... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 21, 2019 Comprehensive RS Cleat CAP, Item No. 110300 Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 21, 2019 HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin ... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 21, 2019 BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product U... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 21, 2019 BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM000009... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 21, 2019 COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 19, 2019 Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatr... Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays i... Class II OrthoPediatrics Corp
Aug 19, 2019 OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing P... Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a de... Class II OrthoPediatrics Corp
Aug 19, 2019 Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pe... Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays i... Class II OrthoPediatrics Corp
Aug 15, 2019 XP-XP Tibial Tray - Interlok 91mm Item # 195761 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 Vanguard XP Tibial Tray 83 mm Item # 195253 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-CR Tibial Tray - Interlok 69mm Item # 195272 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-CR Tibial Tray - Interlok 67mm Item # 195271 The locking bar not fully engaging 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.