Browse Device Recalls

797 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 797 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 797 FDA device recalls in TX.

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DateProductReasonClassFirm
Apr 22, 2024 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Apr 22, 2024 ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Mar 18, 2024 LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019,... Blackout curtains are no longer recommended as a protective barrier against UV/Ozone exposure to ... Class II XENEX Disinfection Services Inc.
Mar 15, 2024 Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang... Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas. Class II Alcon Research, LLC
Feb 21, 2024 SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pa... Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be br... Class II Alcon Research, LLC
Feb 8, 2024 Chromophare Surgical Light System , REF CH00000001 Due to insufficient mounting force the stability of surgical light system cannot be guaranteed. Class II Stryker Communications
Feb 5, 2024 EasyPoint Needle, 25G x 5/8", REF: 82091 The needle cannula of a retractable needle may detach from the needle holder in the patient. Class II Retractable Technologies, Inc.
Dec 19, 2023 Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD ... Accessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to ... Class II OriGen Biomedical, Inc.
Nov 10, 2023 DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 L... Due to incorrect product/device within packaging. Class II Encore Medical, LP
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

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.