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
Nov 13, 2017	VNS Therapy Programmer, Model 3000, v1.0 System	Certain Model 3000 programming events can result in miscalculation of parameters stored in the Mo...	Class II	Cyberonics, Inc
Sep 29, 2017	Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemis...	The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility...	Class II	Abbott Laboratories, Inc
Sep 29, 2017	ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITE...	The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility...	Class II	Abbott Laboratories, Inc
Sep 15, 2017	EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERIL...	It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.	Class II	Encore Medical, Lp
Sep 15, 2017	EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE ...	It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.	Class II	Encore Medical, Lp
Sep 12, 2017	Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable...	Analysis of the difference between the actual device longevity and the battery indicator status p...	Class II	St. Jude Medical, Inc.
Sep 12, 2017	Proclaim DRG Implantable Pulse Generator Model 3664	Analysis of the difference between the actual device longevity and the battery indicator status p...	Class II	St. Jude Medical, Inc.
Sep 12, 2017	Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Gener...	Analysis of the difference between the actual device longevity and the battery indicator status p...	Class II	St. Jude Medical, Inc.
Aug 14, 2017	Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostat...	The US FDA has requested the optional energy treatment settings, "medium" and "low" (Software Pro...	Class II	Edap Technomed Inc.
Aug 8, 2017	Alcon Custom Pak	Alcon is initiating a medical device recall, after receiving notification from a supplier of a re...	Class II	Alcon Research, LTD.
Aug 4, 2017	MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numb...	It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to ...	Class II	Encore Medical, Lp
Aug 2, 2017	The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter wit...	Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has ha...	Class I	OriGen Biomedical, Inc.
Aug 2, 2017	Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, n...	The plastic core of the Decorticating Planer was found to be missing, which could result in scori...	Class II	Orthofix, Inc
Jul 24, 2017	COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit C...	Potential for partially incomplete seal of product, impacting sterility.	Class II	Epimed International
Jul 24, 2017	TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic H...	Potential for partially incomplete seal of product, impacting sterility.	Class II	Epimed International
Jul 24, 2017	RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plas...	Potential for partially incomplete seal of product, impacting sterility.	Class II	Epimed International
Jul 21, 2017	SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. Th...	The plates do not have wells punched for the controls in the patient 1 area.	Class II	Helena Laboratories, Corp.
Jun 30, 2017	ORA System with VerifEye, Catalog Number 8065998300 For use during intraocul...	Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract su...	Class II	Alcon Research, Ltd.
Jun 30, 2017	ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during int...	Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract su...	Class II	Alcon Research, Ltd.
Jun 26, 2017	Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET...	Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.	Class II	Encore Medical, Lp
Jun 26, 2017	Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERIL...	Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.	Class II	Encore Medical, Lp
Jun 26, 2017	Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET...	Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.	Class II	Encore Medical, Lp
Jun 26, 2017	Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERIL...	Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.	Class II	Encore Medical, Lp
Jun 13, 2017	VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No...	Manufacturing process used to assemble the circuit board may result in some devices experiencing ...	Class II	Cyberonics, Inc
Jun 13, 2017	VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No...	Manufacturing process used to assemble the circuit board may result in some devices experiencing ...	Class II	Cyberonics, Inc
Jun 2, 2017	Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO ...	The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop...	Class II	St. Jude Medical, Inc.
Jun 2, 2017	Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Pro...	The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop...	Class II	St. Jude Medical, Inc.
Jun 2, 2017	Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO ...	The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop...	Class II	St. Jude Medical, Inc.
Jun 2, 2017	Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Pro...	The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop...	Class II	St. Jude Medical, Inc.
Jun 2, 2017	Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, P...	The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop...	Class II	St. Jude Medical, Inc.
Jun 2, 2017	Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Pro...	The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop...	Class II	St. Jude Medical, Inc.
May 31, 2017	3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 0...	Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibia...	Class II	Encore Medical, Lp
May 31, 2017	3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01...	Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibia...	Class II	Encore Medical, Lp
May 25, 2017	LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmi...	Multiple shipments or forceful impact to a caster on a LuxOr/LX3 microscope may stress the micros...	Class II	Alcon Research, Ltd.
May 11, 2017	Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G A...	Argon Medical has received a complaint from one of their distributors of a potential packaging de...	Class II	Argon Medical Devices, Inc
Apr 28, 2017	1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Pa...	Potential sterile barrier breach	Class II	KCI USA, INC.
Apr 21, 2017	Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are med...	The exam light may have a tolerance issue with the adapter assembly, which could potentially not ...	Class II	Stryker Communications
Apr 19, 2017	ARIES System and ARIES M1 System	The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen i...	Class II	Luminex Corporation
Apr 4, 2017	"Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitatio...	Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Pro...	Class II	Helena Laboratories, Inc.
Mar 27, 2017	Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblag...	Alcon is initiating a Voluntary Medical Device Removal because the product supplier has stated th...	Class II	Alcon Research, Ltd.
Mar 27, 2017	Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Impl...	Missing Dome Pack accessory.	Class II	Mentor Texas, LP.
Mar 2, 2017	Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA so...	Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VM...	Class II	Ortho Kinematics, Inc
Feb 28, 2017	The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the...	The potential hazard that can arise for the combination of the missing screws and the overloading...	Class II	Stryker Communications
Feb 24, 2017	Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at ...	Due to some cards in this lot reported to have experienced variations in results, (verified by wa...	Class II	Helena Laboratories, Inc.
Feb 9, 2017	RSP Impaction Fixture	During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from t...	Class II	Encore Medical, Lp
Feb 9, 2017	Turon Impaction Fixture	During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from t...	Class II	Encore Medical, Lp
Jan 18, 2017	BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for...	The recalling firm received a complaint from one of their customers of a potential defect in the ...	Class II	Argon Medical Devices, Inc
Jan 18, 2017	T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEED...	The recalling firm received a complaint from one of their customers of a potential defect in the ...	Class II	Argon Medical Devices, Inc
Jan 18, 2017	HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or...	The recalling firm received a complaint from one of their customers of a potential defect in the ...	Class II	Argon Medical Devices, Inc
Jan 17, 2017	ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F	Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ...	Class I	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.