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
Jul 28, 2021 Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbe... Test strip vials may open while inside sealed cartons during shipment. An open vial might expose ... Class II Roche Diabetes Care, Inc.
Jul 28, 2021 Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number ... Test strip vials may open while inside sealed cartons during shipment. An open vial might expose ... Class II Roche Diabetes Care, Inc.
Jul 1, 2021 ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthropl... Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a re... Class II DePuy Orthopaedics, Inc.
Jun 24, 2021 cobas infinity central lab running software version 3.01.03 through 3.02.08, ... Under specific circumstances created by the user, the cobas e flow test results could be replaced... Class II Roche Diagnostics Operations, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM I... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Ite... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM I... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
May 28, 2021 Affinity Four Birthing Bed-used as a birthing bed for women of child bearing ... Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it cou... Class II Hill-Rom, Inc.
May 7, 2021 DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrai... Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number an... Class II DePuy Orthopaedics, Inc.
Apr 30, 2021 NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. ... (1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal openi... Class II Nico Corp.
Apr 30, 2021 WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt... Nonconformities were discovered to the engineering specifications for implant plates and screws. Class II Wishbone Medical, Inc.
Apr 30, 2021 Myriad-LX Light Source-for delivery of light to the surgical field to enhance... (1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal openi... Class II Nico Corp.
Apr 26, 2021 IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 031836... Roche received several complaints regarding increased control recovery and discrepant elevated re... Class II Roche Diagnostics Operations, Inc.
Apr 19, 2021 Econocare Plus Waffle Overlay- Intended for use as a medical device to aid i... Product contamination-a trace amount of dried bodily fluids may expose patients, health care prov... Class II EHOB, Inc.
Apr 7, 2021 Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intende... Recall reason is possible sporadic false negative conventional troponin results. Roche has confir... Class II Roche Diagnostics Operations, Inc.
Apr 7, 2021 Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: in... Recall reason is possible sporadic false negative conventional troponin results. Roche has confir... Class II Roche Diagnostics Operations, Inc.
Mar 26, 2021 InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product U... Product could potentially contain an undersized inner diameter of the 40mm drill bushing which re... Class II Nextremity Solutions
Mar 26, 2021 InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Us... Product could potentially contain an undersized inner diameter of the 40mm drill bushing which re... Class II Nextremity Solutions
Feb 22, 2021 The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Produc... Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ... Class II DePuy Orthopaedics, Inc.
Feb 22, 2021 The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consist... Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ... Class II DePuy Orthopaedics, Inc.
Feb 22, 2021 ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually package... Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ... Class II DePuy Orthopaedics, Inc.
Jan 21, 2021 Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referr... The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does... Class II G & H Wire Company
Jan 15, 2021 Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is inten... Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Sh... Class II Biomet, Inc.
Jan 8, 2021 Universal Femoral Sleeves - Product Usage: used primarily in revision surgeri... The taper dimensions may be out of specification due to a production issue during the manufacturi... Class II DePuy Orthopaedics, Inc.
Jan 6, 2021 9180 Electrolyte Analyzer - Product Usage: intended to be used for the measur... May display Calcium results on the screen with wrong arrow direction which may lead to misinterpr... Class II Roche Diagnostics Operations, Inc.
Jan 4, 2021 Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for r... Manufactured with incorrect material, which may result in the stent being stiffer and potentially... Class II Cook Inc.
Dec 23, 2020 2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 1432985... Device was distributed without a proper marketing authorization. This event is an expansion of RE... Class II Tenderneeds Fertility LLC
Dec 23, 2020 Pro Series Fertility Device (SKU 644042788139) Device was distributed without a proper marketing authorization. Class II Tenderneeds Fertility LLC
Dec 23, 2020 Professional Artificial Intrauterine Insemination Kit (SKU 636391205986) Device was distributed without a proper marketing authorization. Class II Tenderneeds Fertility LLC
Dec 23, 2020 Deluxe At Home Artificial Insemination Kit (SKU 636391205832) Device was distributed without a proper marketing authorization. Class II Tenderneeds Fertility LLC
Dec 23, 2020 TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 13... Device was distributed without a proper marketing authorization. This event is an expansion of RE... Class II Tenderneeds Fertility LLC
Dec 23, 2020 2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, ... Device was distributed without a proper marketing authorization. This event is an expansion of RE... Class II Tenderneeds Fertility LLC
Dec 23, 2020 Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811) Device was distributed without a proper marketing authorization. Class II Tenderneeds Fertility LLC
Dec 23, 2020 Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, S... Device was distributed without a proper marketing authorization. This event is an expansion of RE... Class II Tenderneeds Fertility LLC
Dec 23, 2020 At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870) Device was distributed without a proper marketing authorization. Class II Tenderneeds Fertility LLC
Dec 23, 2020 Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205... Device was distributed without a proper marketing authorization. Class II Tenderneeds Fertility LLC

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.