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BeneView Series. Operator's Manuals: T5 / T8 Class III

Reason: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Mindray DS USA, Inc. 20260831 Ongoing
Distributed: Worldwide - Nationwide and the country of Canada.
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LAPAROSCOPIC PROSTATECTOMY; Model/Item Number (Kit): NIHB0036-07; Class II

Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process.

AVID Medical, Inc. 20260810 Ongoing
Distributed: US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.
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Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number: 804-33-300 (Enovis); 3105-400-030 (Stryker); internal BC-0001 / BC-0220 Software Version: N/A Product Description: Surgical beach-chair positioner that mounts to the accessory rails of the OR table leg section to elevate and support the patient's upper body in the upright (beach chair) position during surgical procedures. Component: No, finished device. The failure is in the BC-0105, subcomponent. Class II

Reason: Due to a manufacturing issue (inadequate weld) for patient head positioning system.

QUANTUM OPS Inc 20260724 Ongoing
Distributed: U.S. Nationwide distribution in the states of CA and TX.
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Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF: 000-0249 Class II

Reason: A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery recall, that may overheat and pose a fire safety risk.

Intellijoint Surgical, Inc. 20260828 Ongoing
Distributed: Worldwide - US Nationwide distribution in the states of CA, TX, MS, NJ and the countries of Singapore, Spain.
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Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test); Class II

Reason: Potential for false negative patient results.

DRG International, Inc. 20260702 Ongoing
Distributed: Worldwide - US Nationwide distribution in the state of NJ and the countries of Azerbaijan, Belgium, Czech Republic, Germany, Hungary, India, Italy, Kuwait, Russia, Spain, Ukraine.
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T1 Patient Monitor. Operator's Manual: T1 Patient Monitor Class III

Reason: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Mindray DS USA, Inc. 20260831 Ongoing
Distributed: Worldwide - Nationwide and the country of Canada.
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TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88; Class II

Reason: Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.

LeMaitre Vascular, Inc. 20260828 Ongoing
Distributed: US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.
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PACK OPEN HEART CFH; Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07; Class II

Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process.

AVID Medical, Inc. 20260810 Ongoing
Distributed: US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.
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HEART PREP TRAY; Model/Item Number (Kit): MECV97W; Class II

Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process.

AVID Medical, Inc. 20260810 Ongoing
Distributed: US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.
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Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V Class III

Reason: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Mindray DS USA, Inc. 20260831 Ongoing
Distributed: Worldwide - Nationwide and the country of Canada.
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