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 501–520 of 1,000 recalls

Class IIOngoing

Merge OrthoPACS, medical imaging diagnostic workstation

Merge Healthcare, Inc.

Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.

June 30, 2026 · DeviceView details →
Class IIOngoing

Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SC 240cm Box 40; Outer Box UPN: M00513402; Inner Box UPN: M00513400. 3. Radial Jaw 4 SC w/ Needle 240cm Box 20; Outer Box UPN: M00513411; Inner Box UPN: M00513410.

Boston Scientific Corporation

Potential for breach in sterile barrier of device packaging.

June 30, 2026 · DeviceView details →
Class IIOngoing

GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB, is a subsidiary of Getinge.

Maquet Critical Care AB

The module did not undergo electrical safety tests and functional tests during production.

June 30, 2026 · DeviceView details →
Class IIOngoing

GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph

GE Medical Systems Information Technologies Inc

Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient.

June 29, 2026 · DeviceView details →
Class IIOngoing

Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Firmware issue potentially leading to loss of geometry movements.

June 29, 2026 · DeviceView details →
Class IIOngoing

American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H

American Contract Systems Inc

The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.

June 29, 2026 · DeviceView details →
Class IIOngoing

Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-6-30, NG-NV-6-40, NG-NV-7-30, NG-NV-7-40

Contego Medical, Inc

Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open following sheath retraction; and if this condition were to occur during a procedure, the result may be loss of intended integrated embolic protection.

June 29, 2026 · DeviceView details →
Class IIOngoing

American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN

American Contract Systems Inc

The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.

June 29, 2026 · DeviceView details →
Class IIOngoing

American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM

American Contract Systems Inc

The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.

June 29, 2026 · DeviceView details →
Class IIOngoing

American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP

American Contract Systems Inc

The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.

June 29, 2026 · DeviceView details →
Class IIIOngoing

Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL

Siemens Healthcare Diagnostics, Inc.

out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.

June 26, 2026 · DeviceView details →
Class IIOngoing

REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument

Beckman Coulter Inc.

Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."

June 26, 2026 · DeviceView details →
Class IIOngoing

Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock

Galt Medical Corporation

Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.

June 26, 2026 · DeviceView details →
Class IIOngoing

ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000

Erbe USA Inc

A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive pressure causing the cryoprobe to rupture.

June 26, 2026 · DeviceView details →
Class IIOngoing

REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument

Beckman Coulter Inc.

Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."

June 26, 2026 · DeviceView details →
Class IIIOngoing

Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL

Siemens Healthcare Diagnostics, Inc.

Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.

June 26, 2026 · DeviceView details →
Class IIOngoing

Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.

Philips Healthcare (Suzhou) Co., Ltd.

Potential of failing to trigger clinical scan during Bolus Tracking.

June 26, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Stretto Model/Catalog Number: Q6 Edge 3 Stretto Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

Pride Mobility Products Corp.

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

June 25, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Quantum Rehab Product Name: Quantum Outback Model/Catalog Number: Quantum Outback Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

Pride Mobility Products Corp.

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

June 25, 2026 · DeviceView details →
Class IIOngoing

Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿ 10801741121064 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A304400A UDI code: 00801741073847¿ 10801741073844 SureStep" Foley Tray System Add-A-Foley Catheter REF: A399400 UDI code: 00801741100369¿ 10801741100366 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A399400A UDI code: 00801741073915¿ 10801741073912 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A904400A UDI code: 00801741074097¿ 10801741074094 SureStep Intermittent Catheter Tray REF: INTAAI UDI code: 00801741183317 10801741183314 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.

C.R. Bard Inc

Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

June 25, 2026 · DeviceView details →
← PreviousPage 26 of 50Next →