Class I - Dangerous
Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775 Biodegradable suture anchor
Smith & Nephew, Inc. Endoscopy Division
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
The products may have been stored at temperatures outside their required storage conditions.
Microbore tubing disconnecting from male luers on the extension sets.
Class I - Dangerous
One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8 Removal head failing during removal of the CD Horizon Spire and Spire Z Spinal System implant. There is a potential for tissue damage to occur and/or minor surgical delay to remove the remaining fragments of the tip.
RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number: 72201805 Biodegradable suture anchor
Smith & Nephew, Inc. Endoscopy Division
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number: 72200783 Biodegradable suture anchor
Smith & Nephew, Inc. Endoscopy Division
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Report that size 5 KLTD airways were packaged in pouches indicating a size of 2.5 and shipped to your facility. The correct size of the KLTD airway is clearly marked on the actual airway product and the physical size difference between 2.5 and 5 is distinct and obvious.
TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue; Part Number: 72202597 Biodegradable suture anchor
Smith & Nephew, Inc. Endoscopy Division
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on August 26, 2011 due to an issue in which the Outlook ES Safety Infusion System may halt infusion but the "RUN" Light Emitting Diodes (LEDs) on the front display continue to advance as if the pump were infusing. The pump emits a backup alarm, but there are no visual indicators that the infusion
OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 Biodegradable suture anchor
Smith & Nephew, Inc. Endoscopy Division
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Laserworld RGB & Piko Nano RGB Models All models are laser light show projectors, and will be used as such.
Laserworld Usa
Class I - Dangerous
A potential lack of certification, and/or missing laser certification, laser safety warning and administrative labels, and potentially incomplete Performance Feature set and incomplete User Information were discovered.
Product not cleared for sale/use in the United States.
Product not cleared for sale/use in the United States.
Class I - Dangerous
The product has the potential to be laser marked as a Medium when it actually is a Small.
GE Healthcare has recently become aware of a number of potential issues associated with the CARESCAPE Monitor B650. No injuries or illnesses have been reported.
Class I - Dangerous
Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
Class I - Dangerous
Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.