Civic Data
FDA RecallsUSDA RecallsAbout

FDA Recalls

  • Food recalls
  • Drug recalls
  • Device recalls

USDA Recalls

  • All USDA recalls
  • Poultry recalls
  • Meat recalls
  • Egg recalls

About

  • About us
  • FDA guides
  • USDA guides
  • Data sources
  • Privacy policy

Data

  • OpenFDA API
  • USDA FSIS

© 2026Civic Data · Data sourced from OpenFDA and USDA FSIS · Not affiliated with the U.S. Food and Drug Administration or the U.S. Department of Agriculture · Always verify against official sources before acting

  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 341–360 of 1,000 recalls

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 · Device
View 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 IOngoing

Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF: 83945B. Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules

Medical Action Industries, Inc. 306

Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.

July 23, 2026 · DeviceView details →
Class IOngoing

Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules

Medical Action Industries, Inc. 306

Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.

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 IOngoing

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 be contaminated with Aspergillus penicillioides.

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 →
← PreviousPage 18 of 50Next →