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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
Feb 26, 2020 BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Ite... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone,... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile,... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone,... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, ... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 1... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, It... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 1... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, ... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile,... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 1... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, It... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 1... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 1... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 25, 2020 Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper A... Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may ... Class II Biomet, Inc.
Feb 17, 2020 Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Prod... A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem. Class II Biomet, Inc.
Feb 12, 2020 Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile.... Proximal end of the driver in the affected product may be oversized in varying degrees, potentia... Class II Nextremity Solutions
Feb 7, 2020 Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immu... The firm has received an increased number of complaints concerning non-reproducible elevated resu... Class II Roche Diagnostics Operations, Inc.
Jan 21, 2020 PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Pr... The firm is removing the product from the market after discussions with the FDA due to lack of 51... Class II Polymer Technology Systems, Inc.
Jan 19, 2020 Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and t... Due to a nonconformance of product contamination (human blood) of Econocare Plus Waffle Overlay p... Class II EHOB, Inc.
Jan 16, 2020 Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is a... The firm has identified factors which contributed to failures relating to thrombus formation and/... Class II Cook Inc.
Jan 7, 2020 cobas infinity core, Material No. 7154003001. The device is a calculator/data... Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Valid... Class II Roche Diagnostics Operations, Inc.
Jan 7, 2020 THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 ... Potential increase in fracture rate was detected during internal testing, in addition to potentia... Class II Zimmer Biomet, Inc.
Jan 3, 2020 SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product i... The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in... Class II DePuy Orthopaedics, Inc.
Dec 27, 2019 Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3... Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, whi... Class II Cook Inc.
Dec 23, 2019 Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00 Potential for the expiration date on the outer label that was applied by Zimmer Biomet to exceed ... Class II Zimmer Biomet, Inc.
Dec 19, 2019 ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332... Potential issue associated with the instrument -end of the shaft could fail to effectively mate w... Class II Zimmer Biomet, Inc.
Dec 16, 2019 Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. ... The product contains a different plate than indicated by the package labeling. The product is lab... Class II Nextremity Solutions
Dec 12, 2019 Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Mode... The lot contained two outer pins instead of one outer and one inner pin. Class II Zimmer Biomet, Inc.
Dec 11, 2019 ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring Syste... Inability to dose the test strips, may result in a temporary inability to get a result that could... Class II Roche Diabetes Care, Inc.
Dec 11, 2019 Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitor... Inability to dose the test strips, may result in a temporary inability to get a result that could... Class II Roche Diabetes Care, Inc.
Dec 11, 2019 Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monit... Inability to dose the test strips, may result in a temporary inability to get a result that could... Class II Roche Diabetes Care, Inc.
Dec 2, 2019 Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with... One brand of batteries have a small dimensional difference in the negative button terminal, which... Class II Polymer Technology Systems, Inc.
Dec 2, 2019 PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, ... One brand of batteries have a small dimensional difference in the negative button terminal, which... Class II Polymer Technology Systems, Inc.
Dec 2, 2019 Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036 One brand of batteries have a small dimensional difference in the negative button terminal, which... Class II Polymer Technology Systems, Inc.
Dec 2, 2019 PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, w... One brand of batteries have a small dimensional difference in the negative button terminal, which... Class II Polymer Technology Systems, Inc.
Nov 11, 2019 Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST Components 2mm shorter than indicated on the package label Class II Nextremity Solutions
Nov 11, 2019 Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST Components 2mm shorter than indicated on the package label Class II Nextremity Solutions
Nov 11, 2019 Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST Components 2mm shorter than indicated on the package label Class II Nextremity Solutions
Nov 8, 2019 CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 ... A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 Cro... Class I Cook Inc.
Nov 8, 2019 CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583... A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 Cro... Class I Cook Inc.
Nov 8, 2019 CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577... A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 Cro... Class I Cook Inc.
Nov 8, 2019 CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 ... A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 Cro... Class I Cook Inc.
Nov 5, 2019 King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visuali... Exhibiting a reversed image. Although the image may appear normal, the users actions will be reve... Class I King Systems Corp. dba Ambu, Inc.
Oct 28, 2019 Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM anti... Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneo... Class II Roche Diagnostics Operations, Inc.
Oct 25, 2019 Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic ma... Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bo... Class II Zimmer Biomet, Inc.
Oct 25, 2019 Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manua... Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bo... 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.