🏥 Medical Devices • 6,839 recalls
Siemens Medical Solutions Diagnostics
The keyboard and monitor may not be properly secured to the monitor arm.
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.
The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. This component (wipes) were initially manufacturer by Smith & Nephew and recalled due to a potential bacterial contamination.
Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
CooperSurgical
Sterility of the device may be compromised due to unsealed pouch
Maquet Medical Systems USA
Maquet has identified an issue with the Maquet PowerLED 700 (certain serial numbers). One or several plastic fixation tabs can break, which can cause the ambient light module to partially detach.
Several complaints were received for the metal support tube missing from the cholangiogram catheter.
On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. This component (wipes) were initially manufacturer by Smith & Nephew and recalled due to a potential bacterial contamination.
The recalling firm reported there was inadvertent omission of quarterly (Q4 - 2013 and Q1 - 2014) dose audits/verifications on the affected products. All of the affected products were appropriately sterilized
AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.
Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.
CP Medical, Inc., is recalling one lot of Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Sutures for failing to meet the USP minimum average value for knot pull (tensile) strength.
Microport Orthopedics
Difficulty removing the cup adaptor from the impaction handle during surgery
Serum albumin component monomer failed to meet internally established end of shelf-life specification.
Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to over- or under-tightening of bolts that may result in system faults, mechanical sound (e.g. scraping, squeaking, rattling), cracks or vibration in the system.
ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. The complaints have been confirmed by ConMed.