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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 3401–3420 of 39,430 recalls

Class IIOngoing

Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen

Cardinal Health 200, LLC

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

May 2, 2025 · DeviceView details →
Class IIOngoing

Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen

Cardinal Health 200, LLC

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

May 2, 2025 · DeviceView details →
Class IIOngoing

Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010

Healthmark Industries Co., Inc.

During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.

May 2, 2025 · DeviceView details →
Class IIOngoing

Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen

Cardinal Health 200, LLC

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

May 2, 2025 · DeviceView details →
Class IIOngoing

Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device

Remel, Inc

Product may have an off color affecting perfomance

May 1, 2025 · DeviceView details →
Class IIOngoing

The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill Stops, as well as verifying the length of the Drill Stops via a ruler and depth markings. The Drill Stop Kit also allows for optional storage of some DLC drills. Drill Stops: The Drill Stop is a reusable (up to 30 osteotomies) hollow cylinder with retention prongs that clips onto the hub of the DLC drill, creating a stop function at the desired predetermined drill depth (6mm, 8mm, 10mm, 11.5mm, 13mm and 16mm). The Drill Stops come in two formats (Short  6-13mm depth, and Long  6-16mm depth), and in several diameters for different diameter drills.

Implant Direct Sybron Manufacturing LLC

The Drill stop kit contains incorrect components.

May 1, 2025 · DeviceView details →
Class IOngoing

Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F

SunMed Holdings, LLC

Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death.

May 1, 2025 · DeviceView details →
Class IIOngoing

GM Helix Acqua Implant, Article Number: 140.984

Straumann USA LLC

It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.

May 1, 2025 · DeviceView details →
Class IIOngoing

BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers

Civco Medical Instruments Co. Inc.

During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place.

May 1, 2025 · DeviceView details →
Class IIOngoing

GM Helix Acqua Implant, Article Number: 140.985

Straumann USA LLC

It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.

May 1, 2025 · DeviceView details →
Class IICompleted

Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670

Beckman Coulter Mishima K.K.

A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are rounded and chamfered, which can prevent the proper formation of the "air layer" required for normal dispensing. The air layer is the air space that separates the cleaning water filled in the probe from the sample sucked into the probe. Maintaining this air space prevents the cleaning water and the sample from mixing. In the defective S probe, the "air layer" was not properly formed, causing the cleaning water and the sample to mix diluting the sample. As a result, the sample mixture dispensed into the cuvette has a lower concentration than the original sample, and the analyte concentration measured is lower than expected results.

April 30, 2025 · DeviceView details →
Class IIOngoing

BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems

BioFire Diagnostics, LLC

Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.

April 30, 2025 · DeviceView details →
Class IIOngoing

Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.

Maquet Cardiopulmonary Ag

HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.

April 30, 2025 · DeviceView details →
Class IICompleted

Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670

Beckman Coulter Mishima K.K.

Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to a lower concentration being dispensed, which may not be detectable by QC checks, which could lead to the reporting of false low test results (Max 34% error at 1.0 microliters and 7% error at 1.6 microliters sample dispensing volume), which may lead to delayed recognition and treatment.

April 30, 2025 · DeviceView details →
Class IIOngoing

Azure S DR MRI SureScan, Product number W3DR01

Medtronic, Inc.

Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment.

April 29, 2025 · DeviceView details →
Class IIOngoing

5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C. c. 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-2.

Fresenius Medical Care Holdings, Inc.

Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.

April 29, 2025 · DeviceView details →
Class IIOngoing

Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A virus (flu A), influenza B virus (flu B), and/or Respiratory Syncytial Virus (RSV) in anterior nasal or nasopharyngeal swab specimens collected by a healthcare provider (HCP), or in anterior nasal swab specimens that are self-collected at a healthcare location, from individuals suspected by their HCP of respiratory viral infection consistent with COVID-19.

Abbott Molecular, Inc.

There were reports of an increase in reactive negative controls and false positive results.

April 28, 2025 · DeviceView details →
Class IIOngoing

Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal (NP) swab specimens collected by a healthcare provider, from individuals with signs and symptoms of respiratory tract infection

Abbott Molecular, Inc.

There were reports of an increase in reactive negative controls and false positive results.

April 28, 2025 · DeviceView details →
Class IIOngoing

Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/A

Alcon Research LLC

Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.

April 28, 2025 · DeviceView details →
Class IIOngoing

NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.

NxStage Medical Inc

Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment.

April 28, 2025 · DeviceView details →
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