Class I - Dangerous
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
Class I - Dangerous
Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
THREAD RETRIEVAL DRILL REF 2224
Zimmer Dental
Class I - Dangerous
Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
Class I - Dangerous
Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.
Class I - Dangerous
Fujifilm is conducting a corrective action due to an FDA inspection.
Class I - Dangerous
It was discovered during a procedure that when the operator made an exposure on the wireless x-ray detector and the image data was sent to the digital radiography system, and error message was displayed " System Error (2063)" which required a reboot and loss of the image.
Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
Baxter Healthcare
Class I - Dangerous
The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette.
Class I - Dangerous
Failure to comply with performance standard requirements (21 CFR 1040.10(f))when operated in the user accessible auto and music modes of operation
Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.
Fujifilm Medical Systems U.S.A.
Class I - Dangerous
Fujifilm is reporting a corrective action due to an FDA inspection.
Class I - Dangerous
There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.
Class I - Dangerous
Specific lots have been reported to produce falsely lower than expected results for Vitamin D
Class I - Dangerous
The table shift in the vertical direction was inverted during the use of CMA (Couch Move Assistant). Therapy may be directed to an incorrect area.
Class I - Dangerous
Burn Sheet has possibility of being shredded.
Multiple shipments or forceful impact to a caster on a LuxOr/LX3 microscope may stress the microscope base, which could contribute to a caster breaking or detaching from the base.
Inadequate detectability of radiopaque stripes
CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc.
Smiths Medical ASD
Class I - Dangerous
The medication cassette reservoir, part number 21-7002-24, with lot number 16X659, may have been manufactured with the incorrect pressure plate and the tubing used on the cassette may have been routed incorrectly.