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  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 521–540 of 39,430 recalls

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 II
Ongoing

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 →
Class IIOngoing

BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use

Becton Dickinson & Co.

BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.

April 7, 2026 · DeviceView details →
Class IIOngoing

BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use

Becton Dickinson & Co.

BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.

April 7, 2026 · DeviceView details →
Class IIOngoing

LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/3.5 mm x 17 mm x 13 mm

MICROVENTION INC.

Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events

April 6, 2026 · DeviceView details →
Class IIOngoing

INZONE DETACHMENT SYSTEM, REF: M00345100950

Stryker Neurovascular

Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.

April 6, 2026 · DeviceView details →
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