Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 8, 2025 | (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS)... | Software issues could potentially result in: 1) delays in accessing dispensing software applicati... | Class II | CareFusion 303, Inc. |
| Jan 8, 2025 | stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating an... | Precision Thin blade attachments have a potential to be out of measurement specifications, preven... | Class II | Stryker Corporation |
| 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 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 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 | 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 5, 2025 | VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Cathe... | Due to an observed trend of neurovascular events | Class I | Biosense Webster, 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 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 | 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 | 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 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 | 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 | 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. |
| 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 | 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 |
| 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 31, 2024 | Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item N... | The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess materia... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| 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 | 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 | Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600... | The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess materia... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| 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 26, 2024 | regard Item Number: 830106006, LD01114F - Newborn Kit containing the componen... | There is a potential for the Inline Controller to be using the spring out of specification causin... | Class I | ROi CPS LLC |
| 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 | 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 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 | 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 | 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 | 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 | VDR4 Phasitron Breathing Circuit Models that contain the venturi component: ... | Due to internal venturi component getting transiently stuck in the forward position within the br... | Class I | Percussionaire Corporation |
| Dec 20, 2024 | Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A | There is an issue with the ventilator battery charger that could lead to an audible and visual al... | Class I | Baxter Healthcare Corporation |
| 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 | 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 | 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 | 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 | 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 | Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP | There is an issue with the ventilator battery charger that could lead to an audible and visual al... | Class I | Baxter Healthcare 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 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 | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use i... | Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power a... | Class I | Max Mobility LLC |
| 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 | 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 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 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 |
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.