Browse Device Recalls

788 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 788 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 788 FDA device recalls in TX.

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Date	Product	Reason	Class	Firm
Apr 6, 2020	OSTEOVATIONEX 5CC, INJECT FORMULA. Product Number: 390-0005, UDI: 8138450200...	Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur...	Class II	Skeletal Kinetics, Llc
Apr 6, 2020	CRANIOSCULPT FLOW, CAN, 5CC. Product Number: C-FLOW5CC-CAN, UDI: 81384502034...	Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur...	Class II	Skeletal Kinetics, Llc
Apr 6, 2020	CRANIOSCULPT FLOW, OUS, 10CC. Product Number: C-FLOW10CC-OUS, UDI: 813845020...	Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur...	Class II	Skeletal Kinetics, Llc
Apr 6, 2020	EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 ...	Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur...	Class II	Skeletal Kinetics, Llc
Apr 6, 2020	OSTEOVATION EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 81384502...	Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur...	Class II	Skeletal Kinetics, Llc
Apr 3, 2020	Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage:...	Potential product mix-up. The recalling firm has determined that one unit of OsteoVation EX, 3cc ...	Class II	Skeletal Kinetics, Llc
Apr 2, 2020	Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACC...	In the case of an AQM clot detection error a portion of the distilled water from the Aliquoter Mo...	Class II	Abbott Laboratories
Apr 2, 2020	OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product U...	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte...	Class II	Osteomed, LLC
Apr 2, 2020	OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product U...	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte...	Class II	Osteomed, LLC
Apr 2, 2020	OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usa...	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte...	Class II	Osteomed, LLC
Apr 2, 2020	OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product ...	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte...	Class II	Osteomed, LLC
Apr 2, 2020	OSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Produc...	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte...	Class II	Osteomed, LLC
Apr 2, 2020	OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Produc...	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte...	Class II	Osteomed, LLC
Apr 2, 2020	OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Us...	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte...	Class II	Osteomed, LLC
Apr 2, 2020	OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product U...	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte...	Class II	Osteomed, LLC
Apr 2, 2020	OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product ...	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte...	Class II	Osteomed, LLC
Apr 2, 2020	OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Pro...	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte...	Class II	Osteomed, LLC
Apr 2, 2020	OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usa...	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte...	Class II	Osteomed, LLC
Apr 2, 2020	OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product ...	Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characte...	Class II	Osteomed, LLC
Mar 18, 2020	Frames Direct Prescription Spectacle Lenses included in the frame brands	The firm has become aware through their optical laboratory supplier that prescription spectacle ...	Class II	Frames Direct
Feb 21, 2020	R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124;...	Incorrect expiration date on introduction cannula packaging.	Class II	Epimed International
Feb 21, 2020	R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496;...	Incorrect expiration date on introduction cannula packaging.	Class II	Epimed International
Feb 4, 2020	VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 81...	False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output curren...	Class II	LivaNova USA Inc
Dec 17, 2019	Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168...	Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or ...	Class II	Quest Medical, Inc.
Dec 4, 2019	0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 1141...	The stiffness of the soft end of the guidewire caused tissue perforation.	Class I	Argon Medical Devices, Inc
Dec 4, 2019	0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114...	The stiffness of the soft end of the guidewire caused tissue perforation.	Class I	Argon Medical Devices, Inc
Dec 2, 2019	BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial...	Incorrect product labeling.	Class II	Argon Medical Devices, Inc
Nov 4, 2019	8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: ...	The firm has identified that parts from the kit, lot: TSL007202, have the potential to contain th...	Class II	Trilliant Surgical, LLC
Oct 22, 2019	EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026...	The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking d...	Class II	Encore Medical, LP
Oct 11, 2019	Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000	The firm has become aware that there is a likelihood that a missing snap ring or spanner nut may ...	Class II	Stryker Communications
Oct 10, 2019	3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Steri...	Labeling Error; specifically, drill bits from lots # TSL008495A are marked with the lot # of TSL0...	Class II	Trilliant Surgical, LLC
Aug 22, 2019	VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal ne...	Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-en...	Class I	LivaNova USA Inc
Aug 21, 2019	CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.	Reports received of the device fracturing during insertion.	Class II	CTL Medical Corporation
Aug 21, 2019	CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.	Reports received of the device fracturing during insertion.	Class II	CTL Medical Corporation
Aug 21, 2019	CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.	Reports received of the device fracturing during insertion.	Class II	CTL Medical Corporation
Aug 21, 2019	CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.	Reports received of the device fracturing during insertion.	Class II	CTL Medical Corporation
Aug 14, 2019	Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A	Due to manufacturing processing error, wrench causing stripping when torqueing nuts.	Class II	New Standard Device Inc
Aug 13, 2019	VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1...	Firm identified a subset of its generators that were sterilized one additional sterilization cycl...	Class II	LivaNova USA Inc
Aug 6, 2019	BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors...	The device data being collected and transferred to the monitoring center may not be accurate due ...	Class II	Preventice Services, LLC
Aug 1, 2019	Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a componen...	The mounts on the monitor may have an insufficient weld.	Class II	Stryker Communications
Jul 23, 2019	'n'-Hole Post which is a component of the Revolution External Fixation System...	The threads on posts stripping out when tensioned during application process.	Class II	New Standard Device Inc
Jul 23, 2019	AggreGuide A-100 Instrument	The firm identified a software design issue where the improper shut down of the instrument result...	Class II	Aggredyne, Inc.
Jul 16, 2019	Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; R...	There was incorrect raw material used in the production of the identified lot.	Class II	TeDan Surgical Innovations LLC
Jun 24, 2019	3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile E...	The firm has become aware that they have distributed product that was expired.	Class II	OriGen Biomedical, Inc.
Jun 6, 2019	OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturi...	A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the...	Class II	Skeletal Kinetics, Llc
Jun 6, 2019	OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturin...	A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the...	Class II	Skeletal Kinetics, Llc
Jun 4, 2019	inLight Medical LED Pads used with Polychromatic light technology system	LED pads with cord connectors that have v-shaped notches may not have been assembled properly. Th...	Class III	Inlightened Partners LLC
May 22, 2019	"HEMOGLOBIN A1c CALIBRATORS * REF 4P52-01 * 307261/R03 * S4P5X0 * FOR...	Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The ma...	Class II	Abbott Laboratories
May 1, 2019	ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry Sy...	Mixer blade may separate from mixer due to the screw and nut failure and detachment. As a result ...	Class II	Abbott Laboratories, Inc
Apr 15, 2019	PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.	There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Posi...	Class II	Hitachi America, Ltd., Power Systems Division

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.