Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prolapse.
Boston Scientific
Class I - Dangerous
Potential for Capio sutures to break and /or detach.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent cartridge
Siemens Healthcare Diagnostics
Class I - Dangerous
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440
Siemens Healthcare Diagnostics
Class I - Dangerous
Incorrect calibrator level listed in qualitative calibration steps
IMMULITE ¿ /IMMULITE ¿ 1000 TG
Siemens Healthcare Diagnostics
Class I - Dangerous
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
Class I - Dangerous
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483
Siemens Healthcare Diagnostics
Class I - Dangerous
Incorrect calibrator level listed in qualitative calibration steps
Class I - Dangerous
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
Class I - Dangerous
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system.
Vygon U.S.A.
Class I - Dangerous
Potential friction holes may affect the sterility of the product.
Class I - Dangerous
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
Class I - Dangerous
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
Class I - Dangerous
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Class I - Dangerous
There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instructed, a transient minor allergic skin reaction may result when handling leaking succinylacetone reagent vials.
Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
Parker Laboratories
Class I - Dangerous
There is a potential for the gel packets to have leaks in the packet seal.
ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
Siemens Medical Solutions USA
Class I - Dangerous
The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.
Class I - Dangerous
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
ADVIA Centaur¿ Folate (FOL)
Siemens Healthcare Diagnostics
Class I - Dangerous
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region
Teleflex Medical Europe
Class I - Dangerous
Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.
Class I - Dangerous
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.