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© 2026Civic Data · Data sourced from OpenFDA, updated weekly · Not affiliated with the U.S. Food and Drug Administration · Always verify against official FDA 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 81–100 of 39,041 recalls

Class IIOngoing

Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

Incomplete seals on sterile product

April 10, 2026 · DeviceView details →
Class IIOngoing

BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

Incomplete seals on sterile product

April 10, 2026 · DeviceView details →
Class II
Ongoing

Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

Incomplete seals on sterile product

April 10, 2026 · DeviceView details →
Class IIOngoing

Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through a series of drainage holes near the catheter's bullet shaped tip.

Integra LifeSciences Corp. (NeuroSciences)

Out-of-specification endotoxin result that did not meet the acceptance criteria.

April 10, 2026 · DeviceView details →
Class IIOngoing

Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

Incomplete seals on sterile product

April 10, 2026 · DeviceView details →
Class IIOngoing

BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

Incomplete seals on sterile product

April 10, 2026 · DeviceView details →
Class IIOngoing

CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

Incomplete seals on sterile product

April 10, 2026 · DeviceView details →
Class IIOngoing

Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

Incomplete seals on sterile product

April 10, 2026 · DeviceView details →
Class IIOngoing

Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

Incomplete seals on sterile product

April 10, 2026 · DeviceView details →
Class IIOngoing

Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

Incomplete seals on sterile product

April 10, 2026 · DeviceView details →
Class IIOngoing

BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

Incomplete seals on sterile product

April 10, 2026 · DeviceView details →
Class IIOngoing

BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

Incomplete seals on sterile product

April 10, 2026 · DeviceView details →
Class IIOngoing

BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

Incomplete seals on sterile product

April 10, 2026 · DeviceView details →
Class IIOngoing

Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.

Stryker Corporation

Due to nonconforming products being inadvertently distributed.

April 9, 2026 · DeviceView details →
Class IIOngoing

SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.

Hologic, Inc

Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

April 8, 2026 · DeviceView details →
Class IIOngoing

Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P

Becton, Dickinson and Company

Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

April 8, 2026 · DeviceView details →
Class IIOngoing

Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B; 3. PROG CT900C CLINICIAN TABLET UK, Model Number CT900C; 4. PROG CT900D CLINICIAN TABLET GLOBAL, Model Number CT900D; 5. PROG CT900E CLINICIAN TABLET GLBL SMSNG, Model Number CT900E; 6. PROG CT900F CLINICIAN TABLET GLBL SMSNG, Model Number CT900F; implanted programmable infusion pump

Medtronic Neuromodulation

Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.

April 8, 2026 · DeviceView details →
Class IIOngoing

Swan-Ganz Pacing Catheter, Models: D200F7;

Becton, Dickinson and Company

Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

April 8, 2026 · DeviceView details →
Class IIOngoing

3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-NS.

Hologic, Inc

Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

April 8, 2026 · DeviceView details →
Class IIOngoing

Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;

Becton, Dickinson and Company

Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

April 8, 2026 · DeviceView details →
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