Medical device recalls

The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.

BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.

BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.

BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.

BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.

Firm is recalling first aid/emergency kits and cabinets which contain Honeywell Eyewash (3 lots) which is being recalled due to leaking bottles.

Users manuals not supplied with 4800-00T US Rapid Therapy System

During continuous postmarket surveillance activities, we have noticed a potential malfunction of individual foot controls of the type S-N1/S-N2. In case the error occurs, the foot control might not switch back to zero position when the pedal is released. Consequently, the motor keeps rotating. If this happens during automatic thread cutting or automatic screwing-in of implants, it may, in the worst case, lead to a serious injury of the patient.

The implant size is incorrectly etched on the implant. The size listed on the box is correct.

The manufacturer received complaints indicating that the device's central handle holder detaches easily from the handle holder ring on the light head during clinical use. In the event of such detachment, particles from the handle holder ring could fall into the sterile field during a procedure.

There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.

The infusion sets were manufactured with an incorrect spin collar.

The infusion sets were manufactured with an incorrect spin collar.

The infusion sets were manufactured with an incorrect spin collar.

The infusion sets were manufactured with an incorrect spin collar.

The infusion sets were manufactured with an incorrect spin collar.

The infusion sets were manufactured with an incorrect spin collar.

The device may process the same sample with two different sample IDs and sample information while using the single tube loader, which has the potential for erroneous results due to the mis-identification.

Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.

Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.

Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.

"Chattering" when cutting burrs are used in bone.

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.