🏥 Medical Devices Class I - Dangerous
The firm was unsuccessful in obtaining a satisfactory Certificate of Conformance from the original vendor of the mattress showing that they are in compliance with labeling requirements.
All Recalls
95,038 total recalls in our database
Incomplete seals on the sterile package may compromise the sterility
Safeline Y-Type Blood Set, Catalog Number V2500
B. Braun Medical
🏥 Medical Devices Class I - Dangerous
Potential for leakage at the joint between the blood filters and tubing
Centurion-Surgical trays DYNJ04079Z CIRCUMCISION TRAY STERILE DYNJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN CIRCUMCISION TRAY
Centurion Medical Products
🏥 Medical Devices Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility
🏥 Medical Devices Class I - Dangerous
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250
Pacific Medical Group
🏥 Medical Devices Class I - Dangerous
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013
Cardinal Health 200
🏥 Medical Devices Class I - Dangerous
The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (¿ 0.2¿C for Genius 2 and ¿ 0.3¿C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2¿C for Genius 2 or +0.3¿C for Genius 3.
AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB
Cardinal Health
🏥 Medical Devices Class I - Dangerous
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Centurion Dental Kits DH775 PREMIUM DENTAL EXAM TRAY DYKA1169B DENTAL KIT Y 2019011690
Centurion Medical Products
🏥 Medical Devices Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility
AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541
Cardinal Health
🏥 Medical Devices Class I - Dangerous
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visualize a patients upper airway and aid in the placement of a tracheal tube. Model Number: KVLVA12
King Systems Corp.
🏥 Medical Devices Class I - Dangerous
Exhibiting a reversed image. Although the image may appear normal, the users actions will be reversed on the display for left and right directions.
AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575
Cardinal Health
🏥 Medical Devices Class I - Dangerous
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Incomplete seals on the sterile package may compromise the sterility
🏥 Medical Devices Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility
Centurion-Skin Prep Trays SP1180 DRY PREP SET SP200 SKIN SCRUB TRAY SP415 STERILE GAUZE SPONGE
Centurion Medical Products
🏥 Medical Devices Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility
Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY TC7370 TRACHEOSTOMY KIT TC7450 DISPOSABLE TRACH TRAY
Centurion Medical Products
🏥 Medical Devices Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility
Centurion-Medicine Cup GMC205 GLASS MEDICINE CUP 2 OUNCE STERILE
Centurion Medical Products
🏥 Medical Devices Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility
Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250
Pacific Medical Group
🏥 Medical Devices Class I - Dangerous
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
Centurion-Infant Feeding Kit IFK840 INFANT FEEDING KIT (8 FR X 40 IN)
Centurion Medical Products
🏥 Medical Devices Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility
Centurion- PT225 PAIN MANAGEMENT TRAY
Centurion Medical Products
🏥 Medical Devices Class I - Dangerous
Incomplete seals on the sterile package may compromise the sterility