The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

23951–23975 of 50435

  • HighFDA (Devices)·Z-0905-2020·2020-02-05

    Haemonetics Recalls Cell Saver Bowl Sets Due to Leak Risk

    Haemonetics is recalling specific Cell Saver bowl sets because they may leak, potentially trapping fluid and causing incomplete washing.

    Product
    Japan DISP SET, 263J, 205J, 208 - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0863-2020·2020-02-05

    Custom Healthcare Systems Recalls Inpatient Dialysis Kits Due to Latex

    Custom Healthcare Systems is recalling 240 inpatient dialysis kits because a component contains latex that was not listed on the product labels.

    Product
    Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0898-2020·2020-02-05

    Haemonetics Recalls Cell Saver Bowl Sets Due to Leak Risk

    Haemonetics is recalling Cell Saver bowl sets because cracks in the inner core may cause leaks and incomplete blood washing.

    Product
    JAPAN BASIC HI SPEED CS5 SET,LN 263J - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0868-2020·2020-02-05

    LivaNova Recalls Cyberonics VNS Therapy AspireHC Model 105 Generators

    LivaNova USA Inc is recalling 106 Cyberonics VNS Therapy AspireHC Model 105 generators due to electrical leakage causing premature battery depletion.

    Product
    Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0900-2020·2020-02-05

    Haemonetics Recalls Cell Saver Bowl Sets Due to Leak Risk

    Haemonetics is recalling 739 Cell Saver bowl sets because cracks in the inner core can cause leaks and incomplete blood washing.

    Product
    JAPAN DISP SET, 261J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and washing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0921-2020·2020-02-05

    Mindray ABS800 Chemistry Analyzer Gas Spring Recall

    Mindray is recalling six ABS800 Chemistry Analyzers due to a potential gas spring failure that poses a low risk of impact injury to users.

    Product
    ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0892-2020·2020-02-05

    Haemonetics Recalls CS Elite Processing Sets Due to Potential Bowl Cracks

    Haemonetics is recalling CS Elite Processing Sets because cracks in the bowl core may cause fluid trapping and incomplete washing.

    Product
    CS Elite Processing Set (225 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0855-2020·2020-02-05

    Vitreq Recalls VitreQ 23G Silicone Tipped Cannula Due to Sterility Concerns

    Vitreq Bv is recalling VitreQ 23G Silicone Tipped Cannulas because microscopic tears in the sterile pouch may compromise sterility.

    Product
    VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0848-2020·2020-02-05

    Vitreq 20G Needles Recalled for Potential Sterility Compromise

    Vitreq Bv is recalling VitreQ 20G Blunt and Brush Needles because microscopic tears in the sterile pouch may compromise sterility.

    Product
    (1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51 GTIN: 8719214221089 (2) VitreQ 20G BF Brush Needles-REF: BF20.D52 GTIN: 8719214221102
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0852-2020·2020-02-05

    Vitreq Recalls VitreQ 25G VFI Cannulas Due to Sterility Concerns

    Vitreq Bv is recalling VitreQ 25G VFI Cannulas because microscopic tears in the sterile pouch may compromise sterility.

    Product
    VitreQ 25G VFI Cannula-REF: CN25.D03 GTIN: 8719214221447
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0890-2020·2020-02-05

    Haemonetics Recalls Cell Saver Fastpacks Due to Potential Bowl Cracks

    Haemonetics is recalling 8,641 Cell Saver 5/5+ Fastpacks because cracks in the bowl core can trap fluid, causing incomplete washing and device errors.

    Product
    CS5/5+ Fastpacks, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0894-2020·2020-02-05

    Haemonetics Recalls CS Elite Fastpack Autotransfusion Devices Due to Leak Risk

    Haemonetics is recalling CS Elite Fastpack autotransfusion devices because cracks in the bowl core may cause leaks and incomplete blood washing.

    Product
    CS Elite Fastpack, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0886-2020·2020-02-05

    Haemonetics Recalls CS5/5+ Bowl Kits Due to Potential Leaks

    Haemonetics is recalling CS5/5+ Bowl Kits because potential leaks may trap fluid, causing device errors and incomplete washing.

    Product
    CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0903-2020·2020-02-05

    Haemonetics Recalls Cell Saver Elite Sets Due to Potential Bowl Leaks

    Haemonetics is recalling Cell Saver Elite sets because potential leaks in the bowl core may cause fluid trapping and incomplete washing.

    Product
    JAPAN CELL SAVER ELITE SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0889-2020·2020-02-05

    Haemonetics Recalls Cell Saver 5/5+ Fastpacks Due to Potential Leaks

    Haemonetics is recalling 1,340 units of Cell Saver 5/5+ Fastpacks because potential leaks in the inner core may cause fluid trapping and incomplete washing.

    Product
    CS5/5+ Fastpacks, 125 mL, 20¿ Res Autotransfusion Device- Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0870-2020·2020-02-05

    Energetiq EQ-400 Light Source Recalled for Safety Interlock Failure

    Energetiq Technology is recalling 15 EQ-400 light sources because a safety interlock may fail to shut down the system if the laser collimator is removed.

    Product
    EQ-400-RH-QZ and EQ-400-LH-BK products Product Usage: The device is a very broadband light source emitting incoherent non-laser light from the Deep UV through the visible wavelengths.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0887-2020·2020-02-05

    Haemonetics Recalls Cell Saver Bowl Sets Due to Leak Risk

    Haemonetics is recalling Cell Saver 5/5+ and Elite bowl sets because they may leak, trapping fluid and causing incomplete washing.

    Product
    High Speed Cell Saver¿5/5+ Bowl Set Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0885-2020·2020-02-05

    Haemonetics Recalls CS5/5+ Fastpacks Due to Potential Bowl Cracks

    Haemonetics is recalling CS5/5+ Fastpacks because cracks in the bowl core may trap fluid, causing device errors and incomplete washing.

    Product
    CS5/5+ Fastpacks, 225 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0893-2020·2020-02-05

    Haemonetics Recalls CS Elite Processing Sets Due to Potential Bowl Cracks

    Haemonetics is recalling CS Elite Processing Sets (125 ml) because cracks in the bowl core may cause fluid trapping and incomplete blood washing.

    Product
    CS Elite Processing Set (125 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0814-2020·2020-02-05

    Sildenafil 200 mg Troche Recall for Labeling and Expiry Issues

    Sildenafil 200 mg Troche is recalled for incorrect labeling and being compounded with expired components. Consumers in Texas should check their bottles and contact the manufacturer for instructions.

    Product
    Sildenafil 200 mg Troche (Clinic)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-0588-2020·2020-02-05

    Frozen Yellowfin Tuna Recalled Due to Elevated Histamine Levels

    Truong Phu Xanh Co. is recalling frozen yellowfin tuna products from Vietnam due to elevated histamine levels. The recall affects multiple brands and cuts distributed to four states.

    Product
    Frozen Yellowfin Tuna, Product of Vietnam, Packaged under the following brands and cuts: Tidal Seafood Tuna Round Steak, size 6 - 8 oz, Size 8 - 10 oz, pack 2X10 lbs; and Sea Mart PREMIUM FROZEN YELLOWFIN TUNA LOINS 5-8 LBS IVP, 30 LBS; Sea Mart GRADE AAA FROZEN…
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0895-2020·2020-02-05

    Haemonetics Recalls CS Elite Fastpack Autotransfusion Devices Due to Leak Risk

    Haemonetics is recalling CS Elite Fastpack autotransfusion devices because cracks in the bowl core may cause leaks and incomplete blood washing.

    Product
    CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0849-2020·2020-02-05

    Vitreq Recalls VitreQ 23G Injection Needles Due to Sterility Concerns

    Vitreq Bv is recalling VitreQ 23G PFC Injection Needles because microscopic tears in the sterile pouch may compromise sterility.

    Product
    VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362
    Category
    Medical Device
    Distribution
    Distributed nationwide