All Recalls

95,018 total recalls in our database

Neotract

🏥 Medical Devices Class I - Dangerous

There is the potential that during implant deployment, the device may not properly deliver a implant.

Jun 24, 2022 Other Medical Devices Nationwide View Details →

Turbett Surgical Container, TS1500

Turbett Surgical

🏥 Medical Devices Class I - Dangerous

Devices were subject to unapproved rework processes.

Apr 14, 2022 Surgical Instruments Nationwide View Details →

Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.

Jun 28, 2022 Diagnostic Equipment Nationwide View Details →

EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.

Boston Scientific

🏥 Medical Devices Class I - Dangerous

Product may be mislabeled.

May 25, 2022 Infusion Pumps View Details →

Merlin.net model MN5000 Software

St. Jude Medical, Cardiac Rhythm Management Division

🏥 Medical Devices Class I - Dangerous

The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.

Jun 17, 2022 Other Medical Devices Nationwide View Details →

EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.

Boston Scientific

🏥 Medical Devices Class I - Dangerous

Product may be mislabeled.

May 25, 2022 Infusion Pumps View Details →

MEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES, Model numbers MSC351420AN, MSC351420ANH, MSC351420ANZ, MSC351430A, MSC351430AZ

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

stability failure

Jun 29, 2022 Other Medical Devices Nationwide View Details →

Legacy Base for Dual Bed Configurations

Craftmatic Industries

🏥 Medical Devices Class I - Dangerous

A potential for dual-configured beds to separate or slip away from one another.

Mar 24, 2017 Other Medical Devices Nationwide View Details →

SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT

North American Diagnostics

🏥 Medical Devices Class I - Dangerous

Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing approval, clearance, or authorization from FDA.

Jun 15, 2022 Diagnostic Equipment Nationwide View Details →

Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted on its distal tip.

Medtronic

🏥 Medical Devices Class I - Dangerous

Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.

Jun 24, 2022 Surgical Instruments Nationwide View Details →

DeWALT 12-inch Sliding Compound Miter Saws

Unknown Manufacturer

🏠 Consumer Products Class III - Low Risk

The miter saw's rear safety guard can break or detach, posing an injury hazard due to projectiles that can strike the user and bystanders and a laceration hazard to the user who could come into direct contact with the saw blade.

Aug 4, 2022 Other Consumer Products Nationwide View Details →