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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
Jan 4, 2019 Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 ... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 ... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 King LTS-D Kit Size 1, Model Number KLTSD431 Size 0 products were incorrectly packaged and labeled as a size 1 products. Class II King Systems Corp. dba Ambu, Inc.
Jan 4, 2019 Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Urethral Dilator Set, Global Product No. G14185 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Wire Guide, Guidewire, Global Product Number G14326 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G1... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G1490... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Cathe... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G498... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Dec 21, 2018 Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766 Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the siz... Class II Zimmer Biomet, Inc.
Dec 21, 2018 Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571 The products were manufactured with longer than specified sheaths. Class II Cook Inc.
Dec 21, 2018 Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764 Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the siz... Class II Zimmer Biomet, Inc.
Dec 21, 2018 Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper A... The product was potentially being packaged without a taper adapter. Class II Zimmer Biomet, Inc.
Dec 19, 2018 Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, ... There is a potential for difficulty in sliding down the retention mechanism on the sets manufactu... Class II Cook Inc.
Dec 19, 2018 Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, ... There is a potential for difficulty in sliding down the retention mechanism on the sets manufactu... Class II Cook Inc.
Dec 17, 2018 Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 035... New endogenous interference claims have been established for the following assays used on the cob... Class II Roche Diagnostics Corporation
Dec 17, 2018 Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roc... Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 mo... Class II Roche Diagnostics Corporation
Dec 17, 2018 Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795... New endogenous interference claims have been established for the following assays used on the cob... Class II Roche Diagnostics Corporation
Dec 17, 2018 Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***add... New endogenous interference claims have been established for the following assays used on the cob... Class II Roche Diagnostics Corporation
Dec 14, 2018 cobas c 111 with ISE analyzers analyzer used in the following assays: a)Crea... COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and... Class II Roche Diagnostics Corporation
Dec 14, 2018 COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant A... COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and... Class II Roche Diagnostics Corporation
Nov 28, 2018 Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 P... There is a potential for silicone shedding during cleaning and sterilization. Class II Zimmer Biomet, Inc.
Nov 28, 2018 Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 ... There is a potential for silicone shedding during cleaning and sterilization. Class II Zimmer Biomet, Inc.
Nov 20, 2018 Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product... One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking... Class II Zimmer Biomet, Inc.
Nov 20, 2018 Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Produ... One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking... Class II Zimmer Biomet, Inc.
Nov 14, 2018 Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT... Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking. Class II Zimmer Biomet, Inc.
Oct 31, 2018 NexGen¿ Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size ... Screw is missing from the package Class II Zimmer Biomet, Inc.
Oct 24, 2018 Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inser... Potential metal burrs in the holes of the device preventing the appropriate drill and transverse... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire - Bullet Tip, 3.0 mm Di... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm L... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet T... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 70 cm Le... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Item Num... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet T... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diam... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 70 cm Le... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108 Label on the outer carton or the patient labels does not match label on the inner sterile packaging Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 100 cm L... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 c... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126 Label on the outer carton or the patient labels does not match label on the inner sterile packaging Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item N... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm ... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... 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.