Includes Information not stated in the intended use.
All Recalls
95,114 total recalls in our database
Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete.
🏥 Medical Devices Class I - Dangerous
During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture
🏥 Medical Devices Class I - Dangerous
GE Healthcare has recently become aware of a potential safety issue due to uncontrolled motion of the walking belt on your T2100 Treadmill.
🏥 Medical Devices Class I - Dangerous
The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the expiration date of 2016-04-30 printed on label in error.
🏥 Medical Devices Class I - Dangerous
Small sized specula were incorrectly packaged in printed bags for the medium sized speculum
🏥 Medical Devices Class I - Dangerous
Stryker Endoscopy is recalling all non expired SERFAS 90 degree Energy Probes due to reports of fragments of the probe breaking off into the patient.
🏥 Medical Devices Class I - Dangerous
Use of the recalled product may result in false positive reports.
🏥 Medical Devices Class I - Dangerous
Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038.
🏥 Medical Devices Class I - Dangerous
IMMULITE 2000/2000XPi Italian Cypress (T23L4), Lots 206 and 208, fail to meet specifications to support the shelf-life stability of 2 years (24 months) expiration date as indicated on the products label.
Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
Varian Medical Systems
🏥 Medical Devices Class I - Dangerous
Varian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzig-style Surface Applicator's Instructions for Use (IFU): Dose Characterization GM11010080 2012-09-06. The actual dose rate of the applicator is approximately 14% higher than the rate published within the IFU. Use of the dose rate as provided by the IFU without modification or independent confirmat
Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
Stryker Sustainability Solutions
🏥 Medical Devices Class I - Dangerous
Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.
🏥 Medical Devices Class I - Dangerous
The intake port may be blocked which can cause the bag to fail to fill.
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
Terumo Cardiovascular Systems
🏥 Medical Devices Class I - Dangerous
The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user.
Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
Stryker Sustainability Solutions
🏥 Medical Devices Class I - Dangerous
Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.
🏥 Medical Devices Class I - Dangerous
There exists a possible position sensor fault in the swivel base axis not being detected by the system software. When moving, the system could potentially exceed its usual speed, resulting in a collision. No injuries reported.
🏥 Medical Devices Class I - Dangerous
Use of the recalled product may result in false positive reports.
Potential component failure resulting in inoperability
🏥 Medical Devices Class I - Dangerous
During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture
🏥 Medical Devices Class I - Dangerous
Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin.