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 481–500 of 1,000 recalls

Class IITerminated

Leica Microsystems M220 F12 Microscope Systems

Leica Microsystems, Inc.

In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope system. There was no patient injury reported for this complaint. However, the identified defect carries some potential injury risk. In the event that this defect may occur, the M220 optics carrier may unintentionally drop into the surgical field, risking contact with the patient.

November 3, 2021 · DeviceView details →
Class IITerminated

The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wide Neck 27BD-21-EN / Steripath Gen2 Blood Collection System - 21G, Long Neck 27BD-23-EN / Steripath Gen2 Blood Collection System - 23G, Long Neck

Magnolia Medical Technologies, Inc.

Due to an uptick of complaints associated with premature needle retraction of blood collection system.

November 2, 2021 · DeviceView details →
Class IITerminated

Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1

Flower Orthopedics Corporation

Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set is available

November 2, 2021 · DeviceView details →
Class IITerminated

smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101

Smith & Nephew, Inc.

Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.

November 1, 2021 · DeviceView details →
Class IITerminated

RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200

Randox Laboratories Ltd.

When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range

November 1, 2021 · DeviceView details →
Class IITerminated

smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102

Smith & Nephew, Inc.

Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.

November 1, 2021 · DeviceView details →
Class IITerminated

smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202

Smith & Nephew, Inc.

Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.

November 1, 2021 · DeviceView details →
Class IITerminated

smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201

Smith & Nephew, Inc.

Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.

November 1, 2021 · DeviceView details →
Class IITerminated

Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps, tissue samples, food bolus, and foreign bodies in the gastrointestinal tract.

Diversatek Healthcare

M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labeling. The outer package labeling is correct.

October 29, 2021 · DeviceView details →
Class IITerminated

Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk

Stradis Medical, LLC dba Stradis Healthcare

This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile version of the same Intravascular Administration Set.

October 28, 2021 · DeviceView details →
Class IITerminated

EVLP Convenience Pack/Kit

Medline Industries Inc

NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

October 27, 2021 · DeviceView details →
Class IITerminated

Venous Access Pack-LF Convenience Kit

Medline Industries Inc

NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

October 27, 2021 · DeviceView details →
Class IITerminated

Major Vascular CDS Convenience Kit

Medline Industries Inc

NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

October 27, 2021 · DeviceView details →
Class IITerminated

Bedside PICC CDS Convenience Kit

Medline Industries Inc

NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

October 27, 2021 · DeviceView details →
Class IITerminated

Neuro Convenience Kit

Medline Industries Inc

NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

October 27, 2021 · DeviceView details →
Class IITerminated

MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441

Aesculap Implant Systems LLC

Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.

October 25, 2021 · DeviceView details →
Class IITerminated

ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954

MEDLINE INDUSTRIES, LP - Northfield

Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the results from this impacted Calcium reagent will not be provided due to probable Quality Control failure. A delay in diagnosis may be experienced with repeat testing resulting in patient (customer) inconvenience, pain, and cost of the repeat blood draw and testing. All HII1220001954 product shipped/stored at a Medline branch between July 2021 and August 2021 in the identified lots were incorrectly stored and shipped. Six (6) boxes have been shipped to end users at room temperature instead of refrigerated (ice). Five (5) boxes are on hold at a Medline warehouse.

October 22, 2021 · DeviceView details →
Class IITerminated

Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354

Siemens Medical Solutions USA, Inc

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

October 20, 2021 · DeviceView details →
Class IITerminated

Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848280

Siemens Medical Solutions USA, Inc

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

October 20, 2021 · DeviceView details →
Class IITerminated

Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848282

Siemens Medical Solutions USA, Inc

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

October 20, 2021 · DeviceView details →
← PreviousPage 25 of 50Next →