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
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.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook 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.