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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 701–720 of 1,000 recalls

Class IIOngoing

ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump

ICU Medical, Inc.

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

June 10, 2026 · DeviceView details →
Class IIOngoing

Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device

Orthofix U.S. LLC

Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

June 10, 2026 · DeviceView details →
Class IIOngoing

Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267

Medline Industries, LP

Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.

June 10, 2026 · DeviceView details →
Class IIOngoing

Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device

Orthofix U.S. LLC

Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

June 10, 2026 · DeviceView details →
Class IIOngoing

Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device

Orthofix U.S. LLC

Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

June 10, 2026 · DeviceView details →
Class IIOngoing

Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ61651J

Medline Industries, LP

Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.

June 10, 2026 · DeviceView details →
Class IOngoing

Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.

Oscor Inc.

Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.

June 10, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical system designed for surgeons to perform minimally invasive surgery.

CMR SURGICAL LIMITED

Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.

June 9, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description: Single Sterile Extension Hose with PLC Connector Component: N/A

Zimmer Surgical Inc

Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.

June 9, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60-1812-101-00 Software Version: N/A Product Description: Dual Sterile Extension Hose with PLC Connector Component: N/A

Zimmer Surgical Inc

Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.

June 9, 2026 · DeviceView details →
Class IIOngoing

Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R

ConvaTec, Inc

Surgical dressing manufactured out of specification (greater thickness).

June 8, 2026 · DeviceView details →
Class IIOngoing

STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640

Stryker Corporation

There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

June 8, 2026 · DeviceView details →
Class IIOngoing

STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600

Stryker Corporation

There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

June 8, 2026 · DeviceView details →
Class IOngoing

MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T; 2) TOTAL KNEE-LF, Medline kit SKU CDSOPT590U; 3) TOTAL KNEE CDS, Medline kit SKU CDS983930J; 4) HIP CDS-LF, Medline kit SKU CDS984556L; 5) HIP CDS-LF, Medline kit SKU CDS984556M; 6) TOTAL KNEE PACK, Medline kit SKU DYNJ905162Q.

Medline Industries, LP

The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.

June 8, 2026 · DeviceView details →
Class IIOngoing

KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,

Klowen Braces

A product error defect may cause incorrect bracket placement.

June 8, 2026 · DeviceView details →
Class IIOngoing

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. ROBOTIC CDS980523M

Medline Industries, LP

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.

June 8, 2026 · DeviceView details →
Class IIOngoing

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. UROLOGY ROBOTIC PROCEDURE PACK DYNJ0945779U

Medline Industries, LP

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.

June 8, 2026 · DeviceView details →
Class IIOngoing

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206; 2) ENT Pack, Pack Number AMS15517; 3) ENT Facial Pack, Pack Number AMS15863A.

Windstone Medical Packaging, Inc.

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.

June 8, 2026 · DeviceView details →
Class IIOngoing

Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.

Siemens Healthcare Diagnostics, Inc.

The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.

June 8, 2026 · DeviceView details →
Class IIOngoing

ARTIS icono ceiling. Model Number: 11328100.

Siemens Medical Solutions USA, Inc

Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.

June 8, 2026 · DeviceView details →
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