Browse Device Recalls

35,653 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,653 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 35,653 FDA device recalls, Class II.

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DateProductReasonClassFirm
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 6, 2025 NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D ... It was identified internally that two commingle events occurred where the metal support post with... Class II Zimmer, Inc.
Jan 6, 2025 Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Ca... Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omiss... Class II Sysmex America, Inc.
Jan 6, 2025 NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F ... It was identified internally that two commingle events occurred where the metal support post with... Class II Zimmer, 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
Jan 3, 2025 Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenien... Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jan 3, 2025 Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/... Their is a potential that implanted pulse generators may stop delivering therapy due to an intern... Class II LivaNova USA, Inc.
Jan 3, 2025 Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000... Their is a potential that implanted pulse generators may stop delivering therapy due to an intern... Class II LivaNova USA, Inc.
Jan 2, 2025 Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI... Disposable set may leak during priming from a female quick connector due to a crack in the female... Class II Belmont Instrument LLC
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.
Jan 2, 2025 Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK ... Due to devices being irradiated above the established specification which my result in package in... Class II US Endodontics, LLC
Jan 2, 2025 ARTIS One Angiographic X-Ray System A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ra... Class II SIEMENS MEDICAL SOLUTIONS USA, INC
Jan 2, 2025 Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and Uni... Identified reagent lots are experiencing a high rate of calibration failures with failure code of... Class II Beckman Coulter Inc.
Dec 31, 2024 AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G ... Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Class II Exactech, Inc.
Dec 31, 2024 Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G... Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Class II Exactech, Inc.
Dec 31, 2024 Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G... Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Class II Exactech, Inc.
Dec 28, 2024 NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-... Due to nasal spray stability failure for bioburden. Class II Neilmed Pharmaceuticals Inc
Dec 23, 2024 AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800, Hollister received reports of decreased skin barrier wear time which could can lead to tube migra... Class II Hollister Incorporated
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 23, 2024 AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787, Hollister received reports of decreased skin barrier wear time which could can lead to tube migra... Class II Hollister Incorporated
Dec 23, 2024 AnchorFast, Oral Endotracheal Tube Fastener, REF 9799, Hollister received reports of decreased skin barrier wear time which could can lead to tube migra... Class II Hollister Incorporated
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 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 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 AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700, Hollister received reports of decreased skin barrier wear time which could can lead to tube migra... Class II Hollister Incorporated
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 AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M... Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M005... Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein ... Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. Class II Randox Laboratories, Limited
Dec 20, 2024 AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680 Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M005... Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: ... Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740 Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
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 20, 2024 HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: ... Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: ... Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519 Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps ca... Class II Baxter Healthcare Corporation
Dec 20, 2024 AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690 Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538 Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps ca... Class II Baxter Healthcare Corporation
Dec 20, 2024 HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M0... Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: ... Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M0... Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750 Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-... Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C). Class II Integrity Implants Inc.
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 AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M005... Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein... Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. Class II Randox Laboratories, Limited
Dec 20, 2024 Baxter Solution Set with Duo-Vent Spike, REF 2R8404 Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps ca... Class II Baxter Healthcare Corporation
Dec 19, 2024 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, 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.