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 6, 2023	0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/...	Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside...	Class I	Nurse Assist, LLC
Nov 6, 2023	Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100M...	Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside...	Class I	Nurse Assist, LLC
Nov 6, 2023	Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER¿ FOIL LID ...	Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside...	Class I	Nurse Assist, LLC
Nov 6, 2023	Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SY...	Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside...	Class I	Nurse Assist, LLC
Nov 6, 2023	0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10M...	Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside...	Class I	Nurse Assist, LLC
Oct 24, 2023	CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A	There is the potential that cooler-heater devices may contain bacterial contamination which could...	Class II	CardioQuip, LLC
Oct 24, 2023	CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A	There is the potential that cooler-heater devices may contain bacterial contamination which could...	Class II	CardioQuip, LLC
Oct 19, 2023	ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-...	The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin...	Class II	Abbott Laboratories
Oct 19, 2023	CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A	There is a potential for the heating-chamber to malfunction resulting in melting/burning of the h...	Class II	CardioQuip, LLC
Oct 19, 2023	Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module...	The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin...	Class II	Abbott Laboratories
Oct 19, 2023	Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module...	The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin...	Class II	Abbott Laboratories
Oct 19, 2023	CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A	There is a potential for the heating-chamber to malfunction resulting in melting/burning of the h...	Class II	CardioQuip, LLC
Oct 5, 2023	REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2	Mislabeling	Class II	Encore Medical, LP
Oct 5, 2023	Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32...	Mislabeling	Class II	Encore Medical, LP
Oct 2, 2023	STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vit...	Deterioration in the stability of the Test Strips results in diminished low-range detection capab...	Class II	Stanbio Laboratory, LP
Sep 29, 2023	DJO EMPOWR Knee Punch Handle, REF: 801-05-040	Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lea...	Class II	Encore Medical, LP
Sep 25, 2023	RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: ...	Two different humeral socket Insert devices were swapped during packaging, which could result in ...	Class II	Encore Medical, LP
Sep 25, 2023	RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, ...	Two different humeral socket Insert devices were swapped during packaging, which could result in ...	Class II	Encore Medical, LP
Sep 7, 2023	Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARAC...	Custom surgical procedure packs contain latex gloves but are labeled as "latex free".	Class II	Alcon Research, LLC
Sep 6, 2023	RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical sho...	Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver	Class II	Encore Medical, LP
Aug 30, 2023	CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Genera...	Ultrasound devices were not authorized, cleared, or approved by FDA, and thus their performance c...	Class II	RoyalVibe Health Ltd.
Aug 24, 2023	Various Medical Products stored on pallets, including but not limited to band...	Various medical devices potentially exposed to rodent and rodent activity. In addition, medical d...	Class II	Inmar Supply Chain Solutions, LLC
Aug 22, 2023	EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705	Knee insert and acetabular system parts were swapped within inner pack prior to the product being...	Class II	Encore Medical, LP
Aug 22, 2023	EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H	Knee insert and acetabular system parts were swapped within inner pack prior to the product being...	Class II	Encore Medical, LP
Aug 22, 2023	REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, ...	Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5...	Class II	Encore Medical, LP
Aug 8, 2023	Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210	Centered glenosphere box may contain an eccentric glenosphere.	Class II	FX SHOULDER
Aug 4, 2023	DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, RE...	Orthopedic device components were not subjected to final sterilization before shipment, which if ...	Class II	Encore Medical, LP
Aug 4, 2023	DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm,...	Orthopedic device components were not subjected to final sterilization before shipment, which if ...	Class II	Encore Medical, LP
Aug 4, 2023	DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, R...	Orthopedic device components were not subjected to final sterilization before shipment, which if ...	Class II	Encore Medical, LP
Aug 4, 2023	DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443	Orthopedic device components were not subjected to final sterilization before shipment, which if ...	Class II	Encore Medical, LP
Aug 4, 2023	DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106	Orthopedic device components were not subjected to final sterilization before shipment, which if ...	Class II	Encore Medical, LP
Jul 18, 2023	Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: ...	Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging...	Class I	Abbott Medical
Jul 18, 2023	Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: Th...	Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging...	Class I	Abbott Medical
Jul 18, 2023	Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Pro...	Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging...	Class I	Abbott Medical
Jul 18, 2023	Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The ...	Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging...	Class I	Abbott Medical
Jul 18, 2023	Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Pro...	Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging...	Class I	Abbott Medical
Jul 18, 2023	Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: ...	Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging...	Class I	Abbott Medical
Jul 18, 2023	Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The ...	Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging...	Class I	Abbott Medical
Jul 14, 2023	Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrog...	For administration of intravenous fluids to a patient s vascular system utilizing needle-free com...	Class II	Quest Medical, Inc.
Jun 8, 2023	Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Fil...	There is the potential that the vena Cava Filter may not perform as intended which may result in ...	Class II	Argon Medical Devices, Inc
May 31, 2023	REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, St...	Screws for osteotomies have contain an undersize screwhead which has the potential to pass throug...	Class II	Osteomed, LLC
May 31, 2023	REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile	Screws for osteotomies have contain an undersize screwhead which has the potential to pass throug...	Class II	Osteomed, LLC
May 30, 2023	Alinity ci-series System Control Module, REF: 03R70-01	There are potential performance issues found in the Alinity ci-series System software versions 3....	Class II	Abbott Laboratories
May 8, 2023	Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12,...	Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer c...	Class II	Galt Medical Corporation
May 8, 2023	Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16	Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer c...	Class II	Galt Medical Corporation
May 2, 2023	Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spif...	Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator...	Class II	Helena Laboratories, Corp.
Apr 4, 2023	GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1s...	Instrument Kits for EPS plates may contain drill guides with incorrect drill depth range of 30mm ...	Class II	GRAMERCY EXTREMITY ORTHOPEDICS
Mar 10, 2023	Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 175...	Sterility; Steril surgical procedure packs contain incomplete seals.	Class II	Alcon Research, LLC
Feb 28, 2023	EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella D...	Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porou...	Class II	Encore Medical, LP
Dec 23, 2022	Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set wi...	Delivery Sets may have tubing that could become detached that could result in patient infection.	Class II	Quest Medical, 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.