American Surgical Delicot 30mm x 70mm Ref: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
American Surgical Ray-Cot 3" x 3" Ref Number: 60-15 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Ray-Cot 1/2" x 1.5" Ref Number: 60-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Delicot non-xray 5 mm x 8 mm Ref Number: 63-01 Non X-Ray Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Ray-Cot 1/4" x 3" Ref Number: 60-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
Class I - Dangerous
Operators noticed unwanted release of evaporating anesthetic agent at the end of the filling procedure. Eye contact with volatile anesthetics can result in serious irritation. Immediate eye flushing and consultation of a physician is recommended. Updated Material Safety Data Sheets (MSDS) for Desflurane recommend wearing safety glasses when handling these substances.
The sterile packaging may be compromised. A protective cap is to be secured on the tip of the drill bit. If the protective cap is not secured, the drill bit may puncture the sterile barrier.
Class I - Dangerous
When testing was conducted using certain lots, VITROS¿ Systems generated results within the measuring range for samples known to not contain measurable hCG. The system reported results up to approximately 7.40 mIU/mL (IU/L) for patient samples that should have been less than the measuring range of the assay (<2.39 mIU/mL (IU/L)).
GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
GE Medical Systems
Class I - Dangerous
Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure.
American Surgical Ultracot 5 mm x 8 mm (Glassine) Ref Number: 23-01G Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Delicot-J 15 mm x 20 mm Ref Number: 63-04J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Policot 1/2" x 1.5" Ref Number: 90-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Ultracot 5 mm x 8 mm Ref Number: 23-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Americot Blue 3/8" x 3/4" Ref Number: 20-14S Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Ultracot 13 mm x 60 mm Ref Number: 23-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Delicot 5 mm x 13 mm Ref Number: 63-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Telfa 1" x 3" Ref Number: 80-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Ultracot 9 mm x 50 mm (Glassine) Ref Number: 23-07G Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Americot Blue 1/8" x 1/8" Ref Number: 20-19S Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Ray-Cot 1" x 3" Ref Number: 60-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility