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.

Clear

Date	Product	Reason	Class	Firm
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
Dec 23, 2020	At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205...	Device was distributed without a proper marketing authorization.	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pre...	Device was distributed without a proper marketing authorization. This event is an expansion of RE...	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	Premium At Home Pro Series Insemination Kit (SKU 644042787927)	Device was distributed without a proper marketing authorization.	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 23350000...	The instruments may become cold welded together when the drill is inserted through the Soft Tissu...	Class II	Biomet, Inc.
Dec 23, 2020	Deluxe At Home Pro Series Insemination Kit (SKU 644042787958)	Device was distributed without a proper marketing authorization.	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum...	Device was distributed without a proper marketing authorization. This event is an expansion of RE...	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001	Device was distributed without a proper marketing authorization. This event is an expansion of RE...	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW	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 Semi-Flex/Rigid Insemination Device (SKU 644042787903)	Device was distributed without a proper marketing authorization.	Class II	Tenderneeds Fertility LLC
Dec 23, 2020	Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046	Device was distributed without a proper marketing authorization. This event is an expansion of RE...	Class II	Tenderneeds Fertility LLC
Dec 18, 2020	Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift wi...	Multirall Q-link strap lock has not been fully engaged in the S65 rail carriage hook by user, lea...	Class I	Hill-Rom, Inc.
Dec 17, 2020	A calculator/data processing module for clinical use is an electronic device ...	A software error results in the unintentional removal of the serum-indices flag that would otherw...	Class II	Roche Diagnostics Operations, Inc.
Dec 16, 2020	Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Nu...	A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that c...	Class II	Cook Medical Llc
Dec 15, 2020	Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056...	Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diameter", which could l...	Class II	DePuy Orthopaedics, Inc.
Dec 8, 2020	Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas ...	Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro ...	Class II	Roche Diagnostics Operations, Inc.
Dec 8, 2020	Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e...	Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro ...	Class II	Roche Diagnostics Operations, Inc.
Dec 2, 2020	CoaguChek XS Prof (Professional) Meters- IVD professional healthcare provider...	Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing ...	Class II	Roche Diagnostics Operations, Inc.
Dec 2, 2020	CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting t...	Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing ...	Class II	Roche Diagnostics Operations, Inc.
Dec 1, 2020	Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: int...	Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure	Class II	Biomet, Inc.
Nov 25, 2020	RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofaci...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation.	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	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.