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
Feb 23, 2026 Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001 Surgical light assembly may not adequate support the weight of the ceiling cover. Class II Stryker Communications
Feb 18, 2026 Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-1... Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class II Mentor Texas, LP.
Feb 18, 2026 CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-10... Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class II Mentor Texas, LP.
Feb 18, 2026 Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120... Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class II Mentor Texas, LP.
Feb 18, 2026 CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-15... Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class II Mentor Texas, LP.
Feb 18, 2026 CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-911... Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class II Mentor Texas, LP.
Feb 18, 2026 CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-11... Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class II Mentor Texas, LP.
Feb 18, 2026 Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP1... Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class II Mentor Texas, LP.
Feb 1, 2026 On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 Heart valves were released and distributed before all required testing was complete, so it cannot... Class II On-X Life Technologies, Inc.
Jan 15, 2026 Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Mo... Knee and Humeral socket implants contain incorrect labeling. Class II Encore Medical, LP
Jan 15, 2026 Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUM... Knee and Humeral socket implants contain incorrect labeling. Class II Encore Medical, LP
Jan 15, 2026 Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCK... Knee and Humeral socket implants contain incorrect labeling. Class II Encore Medical, LP
Jan 5, 2026 EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H... 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and sever... Class II Encore Medical, LP
Jan 5, 2026 EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and sever... Class II Encore Medical, LP
Nov 24, 2025 Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog... Ophthalmic procedure packs may have incomplete seals affecting sterility. Class I Alcon Research LLC
Nov 13, 2025 Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immun... Class II Abbott Laboratories
Nov 3, 2025 Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System ... Labeling contains claims that are not consistently present. Class III Orthofix U.S. LLC
Nov 3, 2025 Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer... Labeling contains claims that are not consistently present. Class III Orthofix U.S. LLC
Nov 3, 2025 Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion Sys... Labeling contains claims that are not consistently present. Class III Orthofix U.S. LLC
Nov 3, 2025 Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PT... Labeling contains claims that are not consistently present. Class III Orthofix U.S. LLC
Nov 3, 2025 Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti ... Labeling contains claims that are not consistently present. Class III Orthofix U.S. LLC
Nov 3, 2025 Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System M... Labeling contains claims that are not consistently present. Class III Orthofix U.S. LLC
Oct 6, 2025 Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Gener... Class II Abbott Medical
Oct 6, 2025 Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Gener... Class II Abbott Medical
Sep 30, 2025 Alcon PRECISION1 One-Day Contact Lenses, -2.25D. Potential for a weak seal in some units resulting in compromise in sterility. Class II Alcon Research LLC
Sep 19, 2025 Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation S... Polyaxial screws do not meet performance standards. Class II Orthofix U.S. LLC
Sep 17, 2025 Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS2... Instructions for use for a foot plating system is being updated to remove the second option of re... Class II CPM Medical Consultants, LLC.
Sep 15, 2025 CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: ... XXX Class II Alcon Research LLC
Sep 12, 2025 Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography a... Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... Class II UIH Technologies LLC
Sep 12, 2025 Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray Syst... Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... Class II UIH Technologies LLC
Sep 12, 2025 Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography a... Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... Class II UIH Technologies LLC
Sep 12, 2025 Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray Syst... Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... Class II UIH Technologies LLC
Sep 12, 2025 Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 0088633321... Due to complaints of increased resistance when advancing the dilator within the introducer sheath... Class II Argon Medical Devices, Inc
Sep 12, 2025 Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray Syst... Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... Class II UIH Technologies LLC
Sep 12, 2025 Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray Syst... Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... Class II UIH Technologies LLC
Sep 12, 2025 Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography a... Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... Class II UIH Technologies LLC
Sep 12, 2025 Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography a... Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... Class II UIH Technologies LLC
Sep 12, 2025 Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray Syst... Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... Class II UIH Technologies LLC
Aug 5, 2025 Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... Due to incomplete seals in the pouch which provide the sterile barrier. Class II Alcon Research LLC
Aug 5, 2025 Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... Due to incomplete seals in the pouch which provide the sterile barrier. Class II Alcon Research LLC
Aug 5, 2025 Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... Due to incomplete seals in the pouch which provide the sterile barrier. Class II Alcon Research LLC
Aug 5, 2025 Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... Due to incomplete seals in the pouch which provide the sterile barrier. Class II Alcon Research LLC
Aug 5, 2025 Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... Due to incomplete seals in the pouch which provide the sterile barrier. Class II Alcon Research LLC
Jul 18, 2025 Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER... Their is a potential that the reamer may kick or bind up during or immediately prior to use. Class II Encore Medical, LP
Jul 18, 2025 Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER... Their is a potential that the reamer may kick or bind up during or immediately prior to use. Class II Encore Medical, LP
Jul 18, 2025 Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray M... Their is a potential that the reamer may kick or bind up during or immediately prior to use. Class II Encore Medical, LP
Jul 18, 2025 Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER... Their is a potential that the reamer may kick or bind up during or immediately prior to use. Class II Encore Medical, LP
Jul 15, 2025 Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade... Surgical lights have stress lines forming on the powder coating, which indicates that powder coat... Class II Stryker Communications
Jul 9, 2025 Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNE... Knee implants contain incorrect labeling (size and/or side incorrect) Class II Encore Medical, LP
Jul 9, 2025 Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNE... Knee implants contain incorrect labeling (size and/or side incorrect) Class II Encore Medical, LP

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.