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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 301–320 of 1,000 recalls

Class IIOngoing

HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English with Gateway - 2 Min CPR UDI-DI code: 0506016712804 HeartSine SAM 360P 360P US Device, US English - 2 Min CPR UDI-DI code: 0506016712068 HeartSine SAM 450P SAM 450P US Device, US English (2 min CPR) UDI-DI code: 0506016712069 The HeartSine samaritan¿ PAD (Public Access Defibrillator) Models SAM 350P, SAM 360P and SAM 450P are indicated for use on victims of cardiac arrest who are exhibiting the following signs: " Unconscious " Not breathing " Without circulation (without a pulse) The devices are indicated for use on patients greater than 8 years old or over 55 lbs. (25 kg) when used with the adult Pad-Pak (Pad-Pak-01 or Pad-Pak-07). They are indicated for use on children between 1 and 8 years of age or up to 55 lbs. (25 kg) when used with the Pediatric-Pad (Pad-Pak-02).

HeartSine Technologies Ltd

Due to a damaged (over stretched) membrane tail that causes an intermittent fault.

July 27, 2026 · DeviceView details →

Class IIOngoing

Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006

restor3d Inc.

Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening/migration, or need for revision surgery.

July 27, 2026 · DeviceView details →

Class IIOngoing

VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811

Biomerieux Inc

The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False resistant results may lead to the use of less effective antibiotic treatments or the association of multiple antibiotics having negative side effects, which could potentially impact patient s health.

July 24, 2026 · DeviceView details →

Class IIOngoing

Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M

Onkos Surgical, Inc.

Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.

July 24, 2026 · DeviceView details →

Class IIOngoing

Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number: THNDRRED62SKIT Software Version: N/A Product Description: Product common name: Percutaneous catheter A complete product description is provided in Attachment 1 (HHE-2026-002 RED62). Component: Penumbra System

Penumbra Inc.

Due to manufacturing issues reperfusion catheters may fracture.

July 24, 2026 · DeviceView details →

Class IIOngoing

Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M

Onkos Surgical, Inc.

Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.

July 24, 2026 · DeviceView details →

Class IIOngoing

Lago X

Spectral Instruments Inc

Momentary absence of On-Screen "X-Ray On" banner during run readiness check.

July 24, 2026 · DeviceView details →

Class IIOngoing

Ami HTX

Spectral Instruments Inc

Momentary absence of On-Screen "X-Ray On" banner during run readiness check.

July 24, 2026 · DeviceView details →

Class IIOngoing

Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number: 804-33-300 (Enovis); 3105-400-030 (Stryker); internal BC-0001 / BC-0220 Software Version: N/A Product Description: Surgical beach-chair positioner that mounts to the accessory rails of the OR table leg section to elevate and support the patient's upper body in the upright (beach chair) position during surgical procedures. Component: No, finished device. The failure is in the BC-0105, subcomponent.

QUANTUM OPS Inc

Due to a manufacturing issue (inadequate weld) for patient head positioning system.

July 24, 2026 · DeviceView details →

Class IIOngoing

Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N

Medline Industries, LP

The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified prior to use and the cannula is used, there is a potential risk of infection or other complications associated with the use of a non-sterile device, including hemolysis, foreign body reaction, thromboembolism, and/or organ dysfunction.

July 23, 2026 · DeviceView details →

Class IIOngoing

Velys Enabling Tech Robotic-Assist Station REF: 451611001

Medos International Sarl

Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.

July 23, 2026 · DeviceView details →

Class IIOngoing

Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture Kit 20/Cs, REF: 81834B; Blood Culture Collection Kit, REF: 81834C. All containing BD ChloraPrep Clear - 1 mL Applicators

Medical Action Industries, Inc. 306

Blood culture convenience kits contain a component subject to a drug recall that due to an an open or incomplete seal on the packaging of the applicator may compromise the component's sterile barrier and if used may lead to localized skin or soft tissue infection.

July 23, 2026 · DeviceView details →

Class IIOngoing

Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation

Merge Healthcare, Inc.

Software issue may cause measurements to be displayed inaccurately.

July 22, 2026 · DeviceView details →

Class IIOngoing

Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02

AVID Medical, Inc.

Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.

July 22, 2026 · DeviceView details →

Class IIOngoing

Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1) DisplayPort Cable REF: M0067933000, M006793300H0, M006793300R0, M006793300D0, M006793300Z0, M0067930000, M006793000R0

Boston Scientific Corporation

A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during installation.

July 22, 2026 · DeviceView details →

Class IIOngoing

Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-01

AVID Medical, Inc.

Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.

July 22, 2026 · DeviceView details →

Class IIOngoing

FUJIFILM Synapse PACS software v7.4.310; radiological image processing system

FUJIFILM Healthcare Americas Corporation

Software issue may cause the ruler measurement to be inaccurate.

July 22, 2026 · DeviceView details →

Class IIOngoing

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD CULTURE KIT DYNDH1444D BLOOD CULTR KT DIVRSN DEVICE DYNDH1866 BLOOD CULTURE KIT DYNDH1462B DYNDH1622C DYNDH1622D DYNDH1622F DYNDH1715B DYNDH2028 DYNDH2048 BLOOD CULTURE-NB DYNDH2089 BLOOD DRAW KIT DYLAB1081 FLOORS BLOOD DRAW KIT DYLAB1080 PEDS BLOOD CULTURE KIT DYNDH1445C PERIPHERAL BLOOD CULTURE KIT DYNDH2350 WICHITA BLOOD CULTURE COLLECT DYNDH2093

Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

July 20, 2026 · DeviceView details →

Class IIOngoing

Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001

Paragonix Technologies Inc.

Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.

July 20, 2026 · DeviceView details →

Class IIOngoing

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A

Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

July 20, 2026 · DeviceView details →

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