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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Date	Product	Reason	Class	Firm
Jul 19, 2022	Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP...	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc...	Class II	Cook Incorporated
Jul 19, 2022	Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-18...	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc...	Class II	Cook Incorporated
Jul 19, 2022	Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP...	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc...	Class II	Cook Incorporated
Jul 19, 2022	Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP...	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc...	Class II	Cook Incorporated
Jul 19, 2022	Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP...	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc...	Class II	Cook Incorporated
Jul 19, 2022	Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-1...	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc...	Class II	Cook Incorporated
Jul 19, 2022	Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180...	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc...	Class II	Cook Incorporated
Jul 19, 2022	Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP...	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc...	Class II	Cook Incorporated
Jul 14, 2022	cobas e801 Immunoassay Analyzer	Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The...	Class II	Roche Diagnostics Operations, Inc.
Jun 29, 2022	Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN	Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fract...	Class II	OrthoPediatrics Corp
Jun 29, 2022	ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotatio...	Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless stee...	Class II	DePuy Orthopaedics, Inc.
May 25, 2022	Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C...	The products may contain excess coating material on the outside and/or interior of the needle com...	Class II	Cook Incorporated
May 18, 2022	MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metall...	The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instruction...	Class II	DePuy Orthopaedics, Inc.
May 5, 2022	Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MW...	The loading cartridges included with these devices may contain a small, unintended, stainless-ste...	Class II	Cook Incorporated
May 5, 2022	Tornado Embolization Microcoil, RPN ...	The loading cartridges included with these devices may contain a small, unintended, stainless-ste...	Class II	Cook Incorporated
May 5, 2022	Nester Embolization Microcoil RPN GPN ...	The loading cartridges included with these devices may contain a small, unintended, stainless-ste...	Class II	Cook Incorporated
Mar 11, 2022	VELYS Robotic-Assisted Solution Base Product No.: 451570100	System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) cha...	Class II	DePuy Orthopaedics, Inc.
Mar 9, 2022	RocheDiabetes Care Platform Software version 2.5.2 material number 0888835300...	Potential for patient data mismatch when using browser "back" button to navigate between patients...	Class II	Roche Diabetes Care, Inc.
Feb 21, 2022	Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782...	Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Emboli...	Class II	Freudenberg Medical, Llc
Feb 21, 2022	Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782...	Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Emboli...	Class II	Freudenberg Medical, Llc
Feb 14, 2022	Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-F...	IFU update includes an update to the Device description, Intended Use/Indications for Use, Contr...	Class III	Cook Medical Incorporated
Feb 14, 2022	BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [It...	Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s...	Class II	Biomet, Inc.
Feb 14, 2022	BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DV...	Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s...	Class II	Biomet, Inc.
Feb 14, 2022	BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [It...	Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s...	Class II	Biomet, Inc.
Feb 14, 2022	BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 85620400...	Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s...	Class II	Biomet, Inc.
Feb 14, 2022	Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/...	IFU update includes an update to the Device description, Intended Use/Indications for Use, Contr...	Class III	Cook Medical Incorporated
Feb 10, 2022	Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU:...	Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ...	Class II	Nextremity Solutions
Feb 10, 2022	Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532...	Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ...	Class II	Nextremity Solutions
Feb 10, 2022	Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532...	Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ...	Class II	Nextremity Solutions
Feb 10, 2022	Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical ...	Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ...	Class II	Nextremity Solutions
Feb 10, 2022	Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU:...	Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ...	Class II	Nextremity Solutions
Jan 14, 2022	(1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead l...	Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate i...	Class II	Hill-Rom, Inc.
Jan 13, 2022	Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone ...	During insertion of the middle phalanx implant into bone, the driver may deform the implant locki...	Class II	Nextremity Solutions
Jan 13, 2022	Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone r...	During insertion of the middle phalanx implant into bone, the driver may deform the implant locki...	Class II	Nextremity Solutions
Jan 7, 2022	Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Pl...	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati...	Class II	Biomet, Inc.
Jan 7, 2022	Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM ...	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati...	Class II	Biomet, Inc.
Jan 7, 2022	Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Pl...	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati...	Class II	Biomet, Inc.
Jan 7, 2022	Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM ...	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati...	Class II	Biomet, Inc.
Jan 7, 2022	Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM ...	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati...	Class II	Biomet, Inc.
Jan 7, 2022	Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM ...	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati...	Class II	Biomet, Inc.
Jan 7, 2022	Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Siz...	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati...	Class II	Biomet, Inc.
Jan 7, 2022	Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Pla...	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati...	Class II	Biomet, Inc.
Jan 5, 2022	ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in t...	May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to...	Class II	DePuy Orthopaedics, Inc.
Jan 5, 2022	ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component ...	May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to...	Class II	DePuy Orthopaedics, Inc.
Dec 23, 2021	Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Mo...	Missing bushing on Liko M220 and M230 causing wear and potential for patient falling	Class II	Hill-Rom, Inc.
Dec 23, 2021	Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Mode...	Missing bushing on Liko M220 and M230 causing wear and potential for patient falling	Class II	Hill-Rom, Inc.
Dec 7, 2021	GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the...	Class II	DePuy Orthopaedics, Inc.
Dec 7, 2021	GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the...	Class II	DePuy Orthopaedics, Inc.
Dec 7, 2021	GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the...	Class II	DePuy Orthopaedics, Inc.
Dec 7, 2021	GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the...	Class II	DePuy Orthopaedics, 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.