Browse Device Recalls

3,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,276 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 3,276 FDA device recalls in 2024.

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DateProductReasonClassFirm
Nov 19, 2024 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Pro... Devices were identified as released after repair without full testing being performed, which incl... Class II Baxter Healthcare Corporation
Nov 19, 2024 VACUETTE SAFELINK, REF: 450210 The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber slee... Class II Greiner Bio-One GmbH
Nov 19, 2024 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Pr... Devices were identified as released after repair without full testing being performed, which incl... Class II Baxter Healthcare Corporation
Nov 19, 2024 SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (... Incomplete or partial pouch seals, which may result in a breach in the sterility. Class II Med Michigan Holding Llc
Nov 19, 2024 Duravent Silicone Ventilation Tube. Model Number: 240075. Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1... Class II Olympus Corporation of the Americas
Nov 18, 2024 Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Re... Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 18, 2024 Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less a... Class II GE Medical Systems, LLC
Nov 18, 2024 Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less a... Class II GE Medical Systems, LLC
Nov 18, 2024 Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-0... Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less a... Class II GE Medical Systems, LLC
Nov 18, 2024 Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5... Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 18, 2024 HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; trac... Complaint defects have been noted regarding the adhesive elements of the device and the frame of ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 18, 2024 HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF... Complaint defects have been noted regarding the adhesive elements of the device and the frame of ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 18, 2024 EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Pr... There is a potential safety risk caused by physical disassociation of the back section from the b... Class II Elucent Medical Inc
Nov 18, 2024 HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF... Complaint defects have been noted regarding the adhesive elements of the device and the frame of ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 18, 2024 Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder n... Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 18, 2024 Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For ... Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The ... Class II Beckman Coulter, Inc.
Nov 18, 2024 HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tra... Complaint defects have been noted regarding the adhesive elements of the device and the frame of ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 18, 2024 Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less a... Class II GE Medical Systems, LLC
Nov 18, 2024 Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less a... Class II GE Medical Systems, LLC
Nov 16, 2024 Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344. Potential for a plan box not updated issue during Interventional procedure with Spectral CT that ... Class II Philips North America Llc
Nov 15, 2024 Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K2401... The warming surfaces or incubator well temperatures of the listed products may exceed the desired... Class II CooperSurgical, Inc.
Nov 15, 2024 Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number:... The warming surfaces or incubator well temperatures of the listed products may exceed the desired... Class II CooperSurgical, Inc.
Nov 15, 2024 Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Nu... The warming surfaces or incubator well temperatures of the listed products may exceed the desired... Class II CooperSurgical, Inc.
Nov 15, 2024 Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: ... The warming surfaces or incubator well temperatures of the listed products may exceed the desired... Class II CooperSurgical, Inc.
Nov 15, 2024 mint Lesion, Software Versions: 3.10.0 and 3.10.1. Some software versions have a malfunction where they may show incorrect orientation labels for a... Class II Mint Medical GmbH
Nov 15, 2024 mint Lesion, Software Versions: 3.9.0 through 3.9.5. Some software versions have a malfunction where they may show incorrect orientation labels for a... Class II Mint Medical GmbH
Nov 15, 2024 Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number:... The warming surfaces or incubator well temperatures of the listed products may exceed the desired... Class II CooperSurgical, Inc.
Nov 15, 2024 Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number... The warming surfaces or incubator well temperatures of the listed products may exceed the desired... Class II CooperSurgical, Inc.
Nov 14, 2024 Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Mo... Potential for the outer stainless-steel tube to break or detach. Class I Kirwan Surgical Products, LLC
Nov 14, 2024 Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Stra... Potential for the outer stainless-steel tube to break or detach. Class I Kirwan Surgical Products, LLC
Nov 14, 2024 Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: ... Potential for the outer stainless-steel tube to break or detach. Class I Kirwan Surgical Products, LLC
Nov 14, 2024 BD Pyxis MedStation ES, REF: 323 Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or ... Class II CareFusion 303, Inc.
Nov 14, 2024 BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324 Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or ... Class II CareFusion 303, Inc.
Nov 14, 2024 Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD722... Potential for the outer stainless-steel tube to break or detach. Class I Kirwan Surgical Products, LLC
Nov 14, 2024 Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Lo... Potential for the outer stainless-steel tube to break or detach. Class I Kirwan Surgical Products, LLC
Nov 14, 2024 Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. ... Potential for the outer stainless-steel tube to break or detach. Class I Kirwan Surgical Products, LLC
Nov 14, 2024 BD Pyxis CII Safe ES, REF: 1116-00 Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or ... Class II CareFusion 303, Inc.
Nov 14, 2024 Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. ... Potential for the outer stainless-steel tube to break or detach. Class I Kirwan Surgical Products, LLC
Nov 13, 2024 Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Cat... Increase in complaints associated with a molding defect within the inner lumen of delivery cartri... Class II Alcon Research LLC
Nov 13, 2024 DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137 The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler p... Class II Beckman Coulter, Inc.
Nov 12, 2024 ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785 Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 12, 2024 STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695 Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 12, 2024 RUMMELL, Medline Item No. ST006ST Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 12, 2024 O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000 Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 12, 2024 STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790 Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 12, 2024 ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870 Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 12, 2024 Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 ... Some units in a single production lot were programmed incorrectly which will result in the VivAer... Class II Aerin Medical, Inc.
Nov 12, 2024 Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens M... Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista¿ Total Magnesium (M... Class II Siemens Healthcare Diagnostics, Inc.
Nov 12, 2024 ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 11, 2024 TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509) An out of specification component may result in the device exhibiting torque output higher than t... Class II Gauthier 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.