Civic Data
FDA RecallsAbout

FDA Recalls

  • Food recalls
  • Drug recalls
  • Device recalls

Browse

  • All recalls

About

  • About us
  • Guides
  • Data sources
  • Privacy policy

Data

  • OpenFDA API

© 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 141–160 of 1,000 recalls

Class IITerminated

TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034

Haemonetics Corporation

Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat.

April 26, 2022 · DeviceView details →
Class IITerminated

SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.

ConvaTec, Inc

Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.

April 22, 2022 · DeviceView details →
Class IITerminated

Colonovideoscope Model CF-H180AL

Olympus Corporation of the Americas

A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of EndoTherapy devices may stick out (approximately 1.4 mm) further than normal protrusion,could lead to patient injury; specifically, mucosal damage that could result in hemorrhage or bleeding

April 22, 2022 · DeviceView details →
Class IITerminated

Ivenix Infusion System (IIS)

Ivenix, Inc.

Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.

April 22, 2022 · DeviceView details →
Class IITerminated

Reliance Synergy Washer/Disinfector

Steris Corporation

The firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.

April 22, 2022 · DeviceView details →
Class IITerminated

3,65 m Extension Set with Luer-lock Connector

Baxter Healthcare Corporation

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

April 21, 2022 · DeviceView details →
Class IITerminated

15 Liters Drain Bag

Baxter Healthcare Corporation

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

April 21, 2022 · DeviceView details →
Class IITerminated

ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier

Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)

Due to interference with the Live Listen feature of hearing aid or AirPods, the user's iPhone may perform automatic processing of the urination sound signal, resulting in lower urination volume and velocity values than expected.

April 21, 2022 · DeviceView details →
Class IITerminated

APD Drain Manifold

Baxter Healthcare Corporation

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

April 21, 2022 · DeviceView details →
Class IITerminated

Locking Cap for PD Catheter Adapter

Baxter Healthcare Corporation

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

April 21, 2022 · DeviceView details →
Class IITerminated

PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19

Oakworks Inc

Product label was printed without the UDI number and warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs.

April 21, 2022 · DeviceView details →
Class IITerminated

Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS

Oakworks Inc

The warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs.

April 21, 2022 · DeviceView details →
Class IITerminated

5 Prong Manifold Set (with Luer Connectors)

Baxter Healthcare Corporation

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

April 21, 2022 · DeviceView details →
Class IITerminated

Effluent Sample Bag

Baxter Healthcare Corporation

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

April 21, 2022 · DeviceView details →
Class IITerminated

Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016). Issue occurs when Platelet Mapping Assay results from a TEG 5000 analyzer are viewed using TEG Manager Software (versions 1.1-4.3.1)

Haemonetics Corporation

When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP or AA % Inhibition and % Aggretagion may be displayed on TEG Manager for the affected assays.

April 19, 2022 · DeviceView details →
Class IITerminated

LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5

Smith & Nephew Inc

It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.

April 19, 2022 · DeviceView details →
Class IITerminated

progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM3004, 4 x 4 cm; PM3006, 6 x 6 cm; and PM3010, 10 x 10 cm.

ProgenaCare

Inner pouch seal may be inadequate resulting in lack of sterility.

April 18, 2022 · DeviceView details →
Class IITerminated

ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number

PROTERIXBIO

FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false positives or false negatives).

April 17, 2022 · DeviceView details →
Class IITerminated

Turbett Surgical Container, TS1500

Turbett Surgical, Inc.

Devices were subject to unapproved rework processes.

April 14, 2022 · DeviceView details →
Class IITerminated

GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

Medacta Usa Inc

A Size 2 trial baseplate was assembled with Size 1 instrument sets.

April 13, 2022 · DeviceView details →
← PreviousPage 8 of 50Next →