All Recalls

95,025 total recalls in our database

The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm Height 14 mm Eccentric LOW (1.5) Material PyC/CoCr, b) Catalog # DWH041 - Diameter 41 m m Height 15 mm Eccentric LOW (1.5) Material PyC/CoCr, c) Catalog # DWH043 - Diameter 43 mm Height 16 mm Eccentric LOW (1.5) Material PyC/CoCr, d) Catalog # DWH046 - Diameter 46 mm Height 17 mm Eccentric LOW (1.5) Material PyC/CoCr, e) Catalog # DWH048 - Diameter 48 mm Height 18 mm Eccentric LOW (1.5) Material PyC/CoCr, f) Catalog # DWH050 - Diameter 50 mm Height 16 mm Eccentric LOW (1.5) Material PyC/CoCr, g) Catalog # DWH051 - Diameter 50 mm Height 19 mm Eccentric LOW (1.5) Material PyC/CoCr, h) Catalog # DWH052 - Diameter 52 mm Height 19 mm Eccentric LOW (1.5) Material PyC/CoCr, i) Catalog # - DWH053 - Diameter 52 mm Height 23 mm Eccentric LOW (1.5) Material PyC/CoCr, j) Catalog # DWH054 - Diameter 54 mm Height 23 mm Eccentric LOW (1.5) Material PyC/CoCr, k) Catalog # DWH139 - Diameter 39 mm Height 14 mm Eccentric HIGH (3.5) Material PyC/CoCr, l) Catalog # DWH141 - Diameter 41 mm Height 15 mm Eccentric HIGH (3.5) Material PyC/CoCr, m) Catalog # DWH143 - Diameter 43 mm Height 16 mm Eccentric HIGH (3.5) Material PyC/CoCr, n) Catalog # DWH146 - 46 mm Height 17 mm Eccentric HIGH (4) Material PyC/CoCr, o) Catalog # DWH148, - Diameter 48 mm Height 18 mm Eccentric HIGH (4) Material PyC/CoCr, p) Catalog # DWH150 - Diameter 50 mm Height 16 mm Eccentric HIGH (4) Material PyC/CoCr, q) Catalog # DWH151 - Diameter 50 mm Height 19 mm Eccentric HIGH (4) Material PyC/CoCr, r) Catalog # DWH152 - Diameter 52 mm Height 19 mm Eccentric HIGH (4) Material PyC/CoCr, s) Catalog # DWH153 - Diameter 52 mm Height 23 mm Eccentric HIGH (4) Material PyC/CoCr, t) Catalog # DWH154 - Diameter 54 mm Height 23 mm Eccentric HIGH (4) Material PyC/CoCr,

Tornier S.A.S.

🏥 Medical Devices Class I - Dangerous

Potential patient exposure to the graphite substrate.

Jun 25, 2021 Implants & Prosthetics View Details →

Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31 Dec 2022. If used beyond expiry, the material performance is likely to decrease and may be observed as weak or no staining, and there is a potential risk that a false negative result could be recorded and may lead to delay of diagnosis due to retest.

Jul 15, 2021 Other Medical Devices Nationwide View Details →

Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.

May 12, 2021 Diagnostic Equipment View Details →

The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. Users advised to conduct a preventive inspection of the probe before and after sterilization/disinfection/cleaning and before and after an interoperative procedure.

Jun 30, 2021 Diagnostic Equipment Nationwide View Details →

Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets

Jun 30, 2021 Infusion Pumps Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of the baseplate, which prevents the insert from locking on the baseplate.

Jul 1, 2021 Other Medical Devices Nationwide View Details →

Ultrasound system control panel arm swivel lock could fail, which could cause the control panel and monitor to swivel freely while a user is positioning the monitor, or transporting/moving the system, which could lead to patient or user musculoskeletal injury.

Jul 22, 2021 Other Medical Devices Nationwide View Details →

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

Jun 21, 2021 Surgical Instruments Nationwide View Details →