Browse Device Recalls

34,057 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 34,057 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 34,057 FDA device recalls — Class II.

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Date	Product	Reason	Class	Firm
Mar 17, 2026	Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art...	A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More spec...	Class II	Straumann USA LLC
Mar 17, 2026	Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: ...	A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More spec...	Class II	Straumann USA LLC
Mar 4, 2026	Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2...	Product labeling includes a fetal indication for use that is not cleared under its 510(k).	Class II	Koven Technology, Inc.
Feb 25, 2026	Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PK...	Olympus identified that the Cutting Forceps contain components for which the supplier did not ade...	Class II	Olympus Corporation of the Americas
Feb 25, 2026	Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting ...	Olympus identified that the Cutting Forceps contain components for which the supplier did not ade...	Class II	Olympus Corporation of the Americas
Feb 25, 2026	Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Produc...	Olympus identified that the Cutting Forceps contain components for which the supplier did not ade...	Class II	Olympus Corporation of the Americas
Feb 25, 2026	Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name...	Olympus identified that the Cutting Forceps contain components for which the supplier did not ade...	Class II	Olympus Corporation of the Americas
Feb 25, 2026	Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Fo...	Olympus identified that the Cutting Forceps contain components for which the supplier did not ade...	Class II	Olympus Corporation of the Americas
Feb 25, 2026	Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS C...	Olympus identified that the Cutting Forceps contain components for which the supplier did not ade...	Class II	Olympus Corporation of the Americas
Feb 25, 2026	Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting ...	Olympus identified that the Cutting Forceps contain components for which the supplier did not ade...	Class II	Olympus Corporation of the Americas
Feb 19, 2026	Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Produ...	Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to...	Class II	AMO Puerto Rico Manufacturing, Inc.
Feb 18, 2026	Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener...	Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights...	Class II	Baxter Healthcare Corporation
Feb 18, 2026	Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog N...	Due to product exhibiting potential to generate either invalid or false negative results.	Class II	Hologic, Inc.
Feb 18, 2026	Cub Pediatric Crib, Model FL19H	Cribs sold in the USA are missing two access door warning labels.	Class II	Stryker Medical Division of Stryker Corporation
Feb 18, 2026	Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Pe...	Due to adapter not being properly aligned or locked in place.	Class II	Elekta, Inc.
Feb 16, 2026	Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm	Drainable large pouch may leak due to manufacturing issue.	Class II	ConvaTec, Inc
Feb 16, 2026	Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm	Drainable large pouch may leak due to manufacturing issue.	Class II	ConvaTec, Inc
Feb 16, 2026	Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm	Drainable large pouch may leak due to manufacturing issue.	Class II	ConvaTec, Inc
Feb 12, 2026	Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.	The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite au...	Class II	Olympus Corporation of the Americas
Feb 12, 2026	Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.	The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite au...	Class II	Olympus Corporation of the Americas
Feb 12, 2026	Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.	The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite au...	Class II	Olympus Corporation of the Americas
Feb 12, 2026	Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.	The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite au...	Class II	Olympus Corporation of the Americas
Feb 11, 2026	Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;	The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article nu...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Feb 11, 2026	Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;	The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article nu...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Feb 11, 2026	BD Alaris" System with Guardrails" Suite MX with Point of Care Unit	Due to product labeling not indicating which Transport Layer Security (TLS) version that must be ...	Class II	CareFusion 303, Inc.
Feb 10, 2026	Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAG...	Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory respo...	Class II	Medline Industries, LP
Feb 10, 2026	Artegraft Vascular Graft; REF#: AG740;	Labeling mix-up resulting in the incorrect lot outer packaging of product.	Class II	LeMaitre Vascular, Inc.
Feb 10, 2026	Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component...	Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)	Class II	Orthalign, Inc
Feb 10, 2026	Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 componen...	Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)	Class II	Orthalign, Inc
Feb 10, 2026	EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner ...	Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on ...	Class II	Boston Scientific Corporation
Feb 9, 2026	Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Softw...	It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to ...	Class II	Abbott Diagnostics Scarborough, Inc.
Feb 6, 2026	Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR	Software anomaly in the patient positioning system may result in positional discrepancy.	Class II	Hitachi, Ltd. Radiation Oncology Systems, Kashi...
Feb 6, 2026	Artelon FlexBand Plus Ref: 41054 & 41057	Augmentation devices failed bacterial endotoxin testing.	Class II	International Life Sciences
Feb 6, 2026	Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) ...	Augmentation devices failed bacterial endotoxin testing.	Class II	International Life Sciences
Feb 6, 2026	Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR	Software anomaly in the patient positioning system may result in positional discrepancy.	Class II	Hitachi, Ltd. Radiation Oncology Systems, Kashi...
Feb 6, 2026	Artelon FlexBand Dynamic Matrix Ref: 31057	Augmentation devices failed bacterial endotoxin testing.	Class II	International Life Sciences
Feb 5, 2026	Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog N...	After receiving customer complaints, investigations confirmed the presence of a positive bias in ...	Class II	Diagnostica Stago, Inc.
Feb 5, 2026	Campy CVA Medium 100/PK, R01272	Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lo...	Class II	Remel, Inc
Feb 4, 2026	Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protei...	The potential of out-of-range results and an underestimation of the free protein S level in norma...	Class II	Diagnostica Stago, Inc.
Feb 3, 2026	Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (...	There is a potential issue that can lead to discordance between the simulated needle trajectory/t...	Class II	GE Medical Systems, LLC
Feb 3, 2026	IBA Proton Therapy System - PROTEUS 235	It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy S...	Class II	Ion Beam Applications S.A.
Feb 3, 2026	Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Cata...	Impactor handle may be missing cross-pin	Class II	Exactech, Inc.
Feb 3, 2026	Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/...	Impactor handle may be missing cross-pin	Class II	Exactech, Inc.
Feb 2, 2026	MICS3 Angled Sagittal Saw Attachment; Part Number: 210490	A potential issue was identified with the torque strength on the external screws of the MICS3 Ang...	Class II	Howmedica Osteonics Corp.
Feb 2, 2026	Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Mod...	The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.	Class II	B Braun Medical Inc
Feb 2, 2026	Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Ca...	The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.	Class II	B Braun Medical Inc
Feb 2, 2026	Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number...	The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.	Class II	B Braun Medical Inc
Jan 30, 2026	Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a devi...	There is a potential cybersecurity vulnerability affecting certain versions of Centricity Univers...	Class II	GE Medical Systems, LLC
Jan 30, 2026	Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a...	There is a potential cybersecurity vulnerability affecting certain versions of Centricity Univers...	Class II	GE Medical Systems, LLC
Jan 30, 2026	Tandem pumps are battery-operated infusion pumps capable of both basal and bo...	The Czech language user guide contained multiple translation errors. The most significant error ...	Class II	Tandem Diabetes Care, 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.