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
Mar 22, 2019	Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical ...	The back cover of the light head was insufficiently assembled and could potentially fall off the ...	Class II	Stryker Communications
Mar 22, 2019	Berchtold Chromophare F628 Surgical Lights. Product Usage: The medical ...	The back cover of the light head was insufficiently assembled and could potentially fall off the ...	Class II	Stryker Communications
Mar 18, 2019	IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the follow...	The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve...	Class II	Ideal Implant Incorporated
Mar 14, 2019	Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver...	A screwdriver used to facilitate implant insertion and removal was found to be out of specificati...	Class II	Trilliant Surgical, LLC
Feb 21, 2019	Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE ...	The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper...	Class II	ArthroCare Corporation
Feb 20, 2019	ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073	Through internal investigation, it was discovered that a portion of side cassette assemblies (S...	Class II	Luminex Corporation
Feb 20, 2019	Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452	Through internal investigation, it was discovered that a portion of side cassette assemblies (S...	Class II	Luminex Corporation
Feb 20, 2019	ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469	Through internal investigation, it was discovered that a portion of side cassette assemblies (S...	Class II	Luminex Corporation
Feb 20, 2019	ARIES GBS Assay , REF 50-10021, UDI # 00840487100165	Through internal investigation, it was discovered that a portion of side cassette assemblies (S...	Class II	Luminex Corporation
Feb 20, 2019	ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158	Through internal investigation, it was discovered that a portion of side cassette assemblies (S...	Class II	Luminex Corporation
Feb 20, 2019	ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059	Through internal investigation, it was discovered that a portion of side cassette assemblies (S...	Class II	Luminex Corporation
Feb 20, 2019	ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295	Through internal investigation, it was discovered that a portion of side cassette assemblies (S...	Class II	Luminex Corporation
Feb 18, 2019	DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: The...	The items identified for recall are labeled as sterile. However, the manufacturer has found that ...	Class II	TeDan Surgical Innovations LLC
Feb 18, 2019	D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR...	The items identified for recall are labeled as sterile. However, the manufacturer has found that ...	Class II	TeDan Surgical Innovations LLC
Feb 18, 2019	DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: The...	The items identified for recall are labeled as sterile. However, the manufacturer has found that ...	Class II	TeDan Surgical Innovations LLC
Feb 18, 2019	D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR...	The items identified for recall are labeled as sterile. However, the manufacturer has found that ...	Class II	TeDan Surgical Innovations LLC
Feb 4, 2019	EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument ...	The firm has received reports/complaints concerning the breakage of the tips of the locking femo...	Class II	Encore Medical, Lp
Jan 18, 2019	SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product U...	Cosmetic Kit was packaged with a mislabel medical product.	Class II	Bellus Medical
Jan 7, 2019	A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z ...	Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly ...	Class II	Acuity Surgical Devices, LLC
Jan 7, 2019	A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z ...	Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly ...	Class II	Acuity Surgical Devices, LLC
Jan 2, 2019	ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is u...	Abbott internal testing has identified that the Magnesium urine application demonstrates depresse...	Class II	Abbott Laboratories, Inc
Dec 26, 2018	Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) G...	On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplifica...	Class III	Luminex Corporation
Dec 10, 2018	VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device i...	No results/incorrect results due to failure of the hybridization heater.	Class II	Luminex Corporation
Nov 16, 2018	Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The fir...	This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the device...	Class II	LivaNova USA Inc
Nov 16, 2018	Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The fi...	This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the device...	Class II	LivaNova USA Inc
Nov 16, 2018	The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), cons...	Lead impedance values reported by the affected VNS generator will be higher compared to those rep...	Class II	LivaNova USA Inc
Nov 16, 2018	VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly	This recall is being initiated due to reports that that the therapy programming tablet with softw...	Class II	LivaNova USA Inc
Nov 16, 2018	Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-...	The product was packaged with the Instructions for Use for a different product (Ascension First C...	Class III	Ascension Orthopedics, Inc
Nov 13, 2018	EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surg...	There is a potential the joint in the suspension of the device is insufficiently assembled.	Class II	Stryker Communications
Oct 16, 2018	(1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, R...	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri...	Class II	Argon Medical Devices, Inc
Oct 16, 2018	Argon Medical Devices Plugs, Male/Female Luer Lock Plug, REF 041295000A, 50/b...	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri...	Class II	Argon Medical Devices, Inc
Oct 16, 2018	Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx....	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri...	Class II	Argon Medical Devices, Inc
Oct 16, 2018	Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, N...	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri...	Class II	Argon Medical Devices, Inc
Oct 16, 2018	Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm n...	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri...	Class II	Argon Medical Devices, Inc
Oct 16, 2018	Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-steri...	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri...	Class II	Argon Medical Devices, Inc
Oct 16, 2018	(1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Conver...	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri...	Class II	Argon Medical Devices, Inc
Oct 16, 2018	Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Sto...	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri...	Class II	Argon Medical Devices, Inc
Oct 16, 2018	(1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straig...	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri...	Class II	Argon Medical Devices, Inc
Oct 11, 2018	St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6...	The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed w...	Class II	St. Jude Medical, Inc.
Sep 21, 2018	Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset...	Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting ...	Class II	Encore Medical, Lp
Sep 19, 2018	Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX...	Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failur...	Class II	Encore Medical, Lp
Sep 14, 2018	VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pac...	Potential to lead to a false negative results.	Class II	Luminex Corporation
Sep 7, 2018	APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Clas...	The firm identified customer sites where modules which the safety pacemaker label is missing. Inf...	Class II	Abbott Laboratories, Inc
Aug 28, 2018	Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The AR...	There is a potential to generate falsely elevated serum or plasma chloride results when using the...	Class II	Abbott Laboratories, Inc
Aug 21, 2018	Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications:...	These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual ca...	Class II	OriGen Biomedical, Inc.
Aug 21, 2018	ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indicati...	These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual ca...	Class II	OriGen Biomedical, Inc.
Aug 21, 2018	Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinfo...	The catheter failed the endotoxin testing.	Class II	OriGen Biomedical, Inc.
Aug 21, 2018	Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: ...	These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual ca...	Class II	OriGen Biomedical, Inc.
Aug 21, 2018	Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinfo...	These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual ca...	Class II	OriGen Biomedical, Inc.
Aug 21, 2018	Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: ...	These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual ca...	Class II	OriGen Biomedical, 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.