All Recalls

95,025 total recalls in our database

Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.

CLINICAL LASERTHERMIA SYSTEMS AB

🏥 Medical Devices Class I - Dangerous

single use devices labeled as sterile may not have been adequately sterilized

Apr 1, 2021 Other Medical Devices Nationwide View Details →

10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures.

Zavation

🏥 Medical Devices Class I - Dangerous

Products distributed as sterile may not have been adequately sterilized

Mar 25, 2021 Infusion Pumps Nationwide View Details →

10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures.

Zavation

🏥 Medical Devices Class I - Dangerous

Products distributed as sterile may not have been adequately sterilized

Mar 25, 2021 Infusion Pumps Nationwide View Details →

ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For use in Orthopedic / spinal procedures.

Zavation

🏥 Medical Devices Class I - Dangerous

Products distributed as sterile may not have been adequately sterilized

Mar 25, 2021 Infusion Pumps Nationwide View Details →

InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use in Orthopedic / spinal procedures.

Zavation

🏥 Medical Devices Class I - Dangerous

Products distributed as sterile may not have been adequately sterilized

Mar 25, 2021 Other Medical Devices Nationwide View Details →

Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.

CLINICAL LASERTHERMIA SYSTEMS AB

🏥 Medical Devices Class I - Dangerous

single use devices labeled as sterile may not have been adequately sterilized

Apr 1, 2021 Other Medical Devices Nationwide View Details →

REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery.

Meta C.G.M. Spa

🏥 Medical Devices Class I - Dangerous

Sterility issues; single use devices labeled as sterile may not have been adequately sterilized

Apr 26, 2021 Other Medical Devices View Details →

ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures.

Zavation

🏥 Medical Devices Class I - Dangerous

Products distributed as sterile may not have been adequately sterilized

Mar 25, 2021 Other Medical Devices Nationwide View Details →

Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD Left Ti-6Al-4V Alloy-is intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-213-11

Zimmer GmbH

🏥 Medical Devices Class I - Dangerous

Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree

May 7, 2021 Other Medical Devices View Details →

Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.

Draeger Medical

🏥 Medical Devices Class I - Dangerous

Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning

Apr 16, 2021 Patient Monitors Nationwide View Details →

InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in Orthopedic / spinal procedures.

Zavation

🏥 Medical Devices Class I - Dangerous

Products distributed as sterile may not have been adequately sterilized

Mar 25, 2021 Other Medical Devices Nationwide View Details →

11G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.

Zavation

🏥 Medical Devices Class I - Dangerous

Products distributed as sterile may not have been adequately sterilized

Mar 25, 2021 Other Medical Devices Nationwide View Details →

Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

LEPU MEDICAL TECHNOLOGY (BEIJING) CO.

🏥 Medical Devices Class I - Dangerous

Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is not authorized, cleared, or approved for marketing and/or distribution in the U.S.

Apr 26, 2021 Diagnostic Equipment View Details →

The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and extracorporeal circuit, and allows gradient rewarming relative to a venous blood temperature. The Sarns" TCM II also features a Cardioplegia System which will supply cooling water for cardioplegia. Device Name / Model Number: TCM II, with Cardioplegia, 110V/60Hz (P/N 164925) TCM II, without Cardioplegia, 110V/60Hz (P/N 164930) TCM II, with Cardioplegia, 220V/50Hz (P/N 164935) TCM II, without Cardioplegia, 220V/50Hz (P/N 164940) TCM (P/N 15747) Catalog Number: 4415, 164925, 164930, 164935, 15747

Terumo Cardiovascular Systems

🏥 Medical Devices Class I - Dangerous

Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices.

Apr 16, 2021 Diagnostic Equipment View Details →