Browse Device Recalls

5,321 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,321 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 5,321 FDA device recalls.

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DateProductReasonClassFirm
Feb 11, 2025 Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number ... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 10, 2025 Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12... Customer-designed sterile surgical procedure packs contain latex components as specified; but, th... Class II Alcon Research LLC
Feb 4, 2025 IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UP... Product is mislabeled with the incorrect fill volume. Class II Angiodynamics, Inc.
Jan 27, 2025 Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators... Class II Merit Medical Systems, Inc.
Jan 10, 2025 BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass,... Automated dispensing device labeling is being updated to strengthen labeling around manual access... Class II CareFusion 303, Inc.
Jan 8, 2025 (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station ... Labeling is insufficient regarding delays in access to medication. The firm is strengthening the ... Class II CareFusion 303, Inc.
Jan 8, 2025 139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2... Labeling update to include a contraindication statement against the use of medicine cabinets in ... Class II CareFusion 303, Inc.
Jan 8, 2025 155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM... Labeling update to include a contraindication statement against the use of medicine cabinets in ... Class II CareFusion 303, Inc.
Jan 8, 2025 139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 100... Labeling update to include a contraindication statement against the use of medicine cabinets in ... Class II CareFusion 303, Inc.
Jan 8, 2025 138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR... Labeling update to include a contraindication statement against the use of medicine cabinets in ... Class II CareFusion 303, Inc.
Jan 3, 2025 Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer... Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorr... Class II XTANT Medical Holdings, Inc
Dec 23, 2024 CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System ma... Snap rings may become partially or completed detached from the shafts within the internal mechani... Class II Accuray Incorporated
Dec 23, 2024 Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797 Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin A... Class II Oxoid Limited
Dec 23, 2024 CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Cathete... Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were ei... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 23, 2024 MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containi... Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were ei... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 16, 2024 CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: ... Potential for certain SKUs and lot numbers were distributed with the incorrect product descriptio... Class II Integra LifeSciences Corp.
Dec 16, 2024 CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 8... Potential for certain SKUs and lot numbers were distributed with the incorrect product descriptio... Class II Integra LifeSciences Corp.
Dec 16, 2024 CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: ... Potential for certain SKUs and lot numbers were distributed with the incorrect product descriptio... Class II Integra LifeSciences Corp.
Dec 12, 2024 Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr) Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. Class II Medtronic Perfusion Systems
Dec 12, 2024 EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr) Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. Class II Medtronic Perfusion Systems
Dec 12, 2024 DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 770... Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. Class II Medtronic Perfusion Systems
Dec 5, 2024 LINK MP Reconstruction System Neck Segment (with suture holes, standard, unc... Error on the main label and the patient label. The labels indicate a size XXL, this is a standard... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACT... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPAT... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TIS... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCI... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLS... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK Q... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG E... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" B... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERIN... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOO... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RET... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BON... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FR... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANE... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOC... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HE... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INF... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA N... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU D... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTE... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is ... Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the inc... Class III Qualigen 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.