Class I - Dangerous
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that the instrument malfunctioned and golden stop slid from its fixed position during use.
Class I - Dangerous
The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.
Class I - Dangerous
The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.
Class I - Dangerous
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
Class I - Dangerous
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Terumo Cardiovascular Systems
Class I - Dangerous
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
Class I - Dangerous
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
Smith & Nephew, Inc. Endoscopy Division
Class I - Dangerous
Sterility of device is compromised due to breach in sterile barrier
Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.
Baxter Healthcare
Class I - Dangerous
Inadequate iodine and packaging related defects.
SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue
Smith & Nephew, Inc. Endoscopy Division
Class I - Dangerous
Sterility of device is compromised due to breach in sterile barrier
Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
MTI Precision Products
Class I - Dangerous
Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece.
SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue
Smith & Nephew, Inc. Endoscopy Division
Class I - Dangerous
Sterility of device is compromised due to breach in sterile barrier
SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue
Smith & Nephew, Inc. Endoscopy Division
Class I - Dangerous
Sterility of device is compromised due to breach in sterile barrier
Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The motor has a speed range of 100 to 5000 rpm capability.
Dental EZ Group Star Dental Division
Class I - Dangerous
The housing of 5K motor was laser marked incorrectly as a 20K motor. The recall was expanded in September 2014 to include additional lot #2251181.
SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener, fixation, nondegradable, soft tissue
Smith & Nephew, Inc. Endoscopy Division
Class I - Dangerous
Sterility of device is compromised due to breach in sterile barrier
Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
Teleflex Medical
Class I - Dangerous
The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
Amerigel Wound Dressing 1 oz. tube
Kova Laboratories
Class I - Dangerous
Product may not have been manufactured pursuant to a validated process protocol and CGMP.
Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas humidifier adaptor.
Teleflex Medical
Class I - Dangerous
The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
Class I - Dangerous
The Aquatec¿ Fixed Backrest withstands a load of only 250 newtons at uneven load. This may result in the Fixed Backrest becoming detached from the frame.