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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 28, 2026 | HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible... | Labeling; Oxygen Cylinders do not contain required medical gas labeling | Class II | Ventec Life Systems, Inc. |
| Jul 28, 2026 | REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Cons... | Labeling; Oxygen Cylinders do not contain required medical gas labeling | Class II | Ventec Life Systems, Inc. |
| Jul 28, 2026 | REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compat... | Labeling; Oxygen Cylinders do not contain required medical gas labeling | Class II | Ventec Life Systems, Inc. |
| Jul 27, 2026 | Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 583... | Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which ma... | Class II | restor3d Inc. |
| Jul 27, 2026 | HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 05... | Due to a damaged (over stretched) membrane tail that causes an intermittent fault. | Class II | HeartSine Technologies Ltd |
| Jul 24, 2026 | Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patie... | Due to a manufacturing issue (inadequate weld) for patient head positioning system. | Class II | QUANTUM OPS Inc |
| Jul 24, 2026 | Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-AC... | Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers. | Class II | Onkos Surgical, Inc. |
| Jul 24, 2026 | Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-AC... | Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers. | Class II | Onkos Surgical, Inc. |
| Jul 24, 2026 | Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penu... | Due to manufacturing issues reperfusion catheters may fracture. | Class II | Penumbra Inc. |
| Jul 24, 2026 | VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, ... | The issue is related to card pouch damage associated with a portion of the lot which was produced... | Class II | Biomerieux Inc |
| Jul 24, 2026 | Ami HTX | Momentary absence of On-Screen "X-Ray On" banner during run readiness check. | Class II | Spectral Instruments Inc |
| Jul 24, 2026 | Lago X | Momentary absence of On-Screen "X-Ray On" banner during run readiness check. | Class II | Spectral Instruments Inc |
| Jul 23, 2026 | Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture K... | Blood culture convenience kits contain a component subject to a drug recall that due to an an ope... | Class II | Medical Action Industries, Inc. 306 |
| Jul 23, 2026 | Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N | The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for... | Class II | Medline Industries, LP |
| Jul 23, 2026 | Velys Enabling Tech Robotic-Assist Station REF: 451611001 | Software issue within robotic controller which may cause unintended movement of the robotic arm d... | Class II | Medos International Sarl |
| Jul 22, 2026 | Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep ... | Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or i... | Class II | AVID Medical, Inc. |
| Jul 22, 2026 | Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep ... | Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or i... | Class II | AVID Medical, Inc. |
| Jul 22, 2026 | Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Powe... | A subset of power adapters used with the connect console may exhibit higher-than-expected resista... | Class II | Boston Scientific Corporation |
| Jul 22, 2026 | FUJIFILM Synapse PACS software v7.4.310; radiological image processing system | Software issue may cause the ruler measurement to be inaccurate. | Class II | FUJIFILM Healthcare Americas Corporation |
| Jul 22, 2026 | Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation | Software issue may cause measurements to be displayed inaccurately. | Class II | Merge Healthcare, Inc. |
| Jul 20, 2026 | Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. ... | Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall t... | Class II | Mirion Technologies (Capintec), Inc. |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209 | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addit... | Class II | GE Medical Systems Information Technologies Inc |
| Jul 20, 2026 | Dentsply Sirona Capsule Mixer Model No. 5546068 | Potential for electrical discharge from unit when unplugged. | Class II | SDI Limited |
| Jul 20, 2026 | Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Soft... | A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an i... | Class II | Midmark Corporation |
| Jul 20, 2026 | FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 570... | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addit... | Class II | GE Medical Systems Information Technologies Inc |
| Jul 20, 2026 | Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software ... | A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an i... | Class II | Midmark Corporation |
| Jul 20, 2026 | PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592 | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addit... | Class II | GE Medical Systems Information Technologies Inc |
| Jul 20, 2026 | PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353 | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addit... | Class II | GE Medical Systems Information Technologies Inc |
| Jul 20, 2026 | Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF#... | Due to a firmware defect, the portable organ transfer device datalogger may lose its configuratio... | Class II | Paragonix Technologies Inc. |
| Jul 17, 2026 | Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Ex... | Due to blood-to-glycol leak in the heat exchanger. | Class II | SPECTRUM MEDICAL SRL |
| Jul 17, 2026 | Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Ex... | Due to blood-to-glycol leak in the heat exchanger. | Class II | SPECTRUM MEDICAL SRL |
| Jul 17, 2026 | Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number ... | Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria... | Class II | Remel Europe Ltd. |
| Jul 16, 2026 | Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Appl... | A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software i... | Class II | Tandem Diabetes Care, Inc. |
| Jul 16, 2026 | Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 7220... | Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degr... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jul 16, 2026 | Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxoli... | Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently con... | Class II | Straumann USA LLC |
| Jul 16, 2026 | Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 7222... | Two software related issues: 1) Potential image quality degradation that may lead to delay of t... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jul 16, 2026 | FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)008514580051... | Firm has identified mismatches between the outbreak strain and the reference strain used in the d... | Class II | Biofire Defense |
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.