Class I - Dangerous
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Class I - Dangerous
Potential for hole in package compromising sterility of the medical kit.
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
Class I - Dangerous
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
Class I - Dangerous
Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
Class I - Dangerous
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
Medtronic Perfusion Systems
Class I - Dangerous
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
BD Pyxis MedStation ES AUX, REF 324
CareFusion 303
Class I - Dangerous
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;
Adept Medical
Class I - Dangerous
Lack of 510(k) clearance.
Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
Adept Medical
Class I - Dangerous
Lack of 510(k) clearance.
Class I - Dangerous
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
Boston Scientific
Class I - Dangerous
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
Baxter Healthcare
Class I - Dangerous
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.
Augustine Temperature Management
Class I - Dangerous
HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
8MM,HORIZON SMALL CLIP APPLIER,IS4000Āæ REF 470401
Intuitive Surgical
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
8MM,MEGA SUTURECUT ND,IS4000 REF 471309
Intuitive Surgical
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Reports of various packaging issues that may result in a breach of the sterile barrier.
8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
Intuitive Surgical
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.