Browse Device Recalls

3,191 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,191 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 3,191 FDA device recalls.

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DateProductReasonClassFirm
Jan 27, 2025 ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a den... Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... Class II Hiossen Inc.
Jan 24, 2025 Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device M... Devices were distributed in the U.S. market without obtaining the required FDA premarket authoriz... Class II Guangzhou Pluslife Biotech Co., Ltd.
Jan 17, 2025 Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catal... Regulatory documentation error and misleading color packaging claim. Class II Zhejiang Luyao Electronics Technology Co., Ltd.
Jan 16, 2025 Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeut... Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch... Class II Scientia Vascular, Inc.
Jan 10, 2025 . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP ... Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin t... Class II Nobel Biocare
Jan 10, 2025 Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Ge... Potential that the induction seal is not completely sealed to the device tube packaging. Class II Integra LifeSciences Corp.
Jan 8, 2025 The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the ... Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Sp... Class II Hologic, Inc.
Jan 2, 2025 Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socra... Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch... Class II Scientia Vascular, Inc.
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 20, 2024 PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Sutur... Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specifi... Class II Ethicon, LLC
Dec 20, 2024 ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not so... Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specifi... Class II Ethicon, LLC
Dec 20, 2024 PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLEN... Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specifi... Class II Ethicon, LLC
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 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEA... 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" CURETTE EX... 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 BACKHAUS... 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 HEGAR DI... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 2, 2024 Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Co... Sterility assurance; microcatheter inner packaging may contain incomplete seal. Class II MICROVENTION INC.
Nov 26, 2024 Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 882... Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging. Class II O&M HALYARD, INC.
Nov 8, 2024 O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Pro... Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Fac... Class II O&M HALYARD, INC.
Nov 8, 2024 O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical... Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Fac... Class II O&M HALYARD, INC.
Oct 29, 2024 BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor. Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the... Class II Smith & Nephew Inc.
Oct 29, 2024 EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5... Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary ha... Class II MicroPort Orthopedics Inc.
Oct 28, 2024 AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UP... Class II Boston Scientific Corporation
Oct 28, 2024 AMS Artificial Urinary Sphincter Control Pump Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UP... Class II Boston Scientific Corporation

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.