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.

28526–28550 of 50488

  • HighFDA (Devices)·Z-2155-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

    Sun Med, LLC is recalling 60 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, allowing the port to detach and impact air delivery.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH LARGE ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126FL
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2193-2018·2018-06-20

    Angiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxins

    Angiodynamics Inc. is recalling Bio-Stable 5F kits because components may contain unsafe levels of bacterial endotoxins.

    Product
    Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2150-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Retaining Ring Defect

    Sun Med, LLC is recalling 40 cases of Medline Adult Manual Resuscitators because a retaining ring may not seat fully, allowing the patient port to detach and impact air delivery.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116PC
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1579-2018·2018-06-20

    Newly Weds Foods Recalls Commercial Breaders and Batters Due to Foreign Plastic

    Newly Weds Foods Inc is recalling specific lots of commercial breaders and batters because they may contain foreign plastic material.

    Product
    Commercial breaders and batters Product B58042 Breader XI- 50 pound bags Product B58915 Breader X1- 40 pound bags Product B29767 Batter Mix X1- 50 pound bags Product B57802 CTFSH BRDR X1 - 25 pound bags Product B91412 MSRM BRDR X1- 40 pound bags Product B97705 Breader X3…
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1559-2018·2018-06-20

    H-E-B Lime Sherbet Recalled for Potential Broken Metal Pieces

    H-E-B is recalling Lime Sherbet quarts because they may contain broken metal pieces. The product was distributed in Texas and Mexico.

    Product
    HEB Creamy Creations Lime Sherbet quart
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2179-2018·2018-06-20

    Datascope Recalls Pediatric Cardiopulmonary Bypass Tubing Kits Due to Valve Defect

    Datascope Corporation is recalling 27 pediatric cardiopulmonary bypass tubing kits because the over-pressure safety valve may fail to allow flow.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2177-2018·2018-06-20

    Zimmer Biomet Recalls 75mm Tibial Tray Implants Due to Sizing Error

    Zimmer Biomet is recalling 16 units of 75mm tibial tray implants that may be incorrectly labeled as 79mm. This error could lead to surgical delays or the need for immediate revision surgery.

    Product
    Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total Knee Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-1575-2018·2018-06-20

    BISCUIT FOOD Cheese Biscuits Recalled for Undeclared Milk

    SDQ Trading Inc. is recalling BISCUIT FOOD Cheese Biscuits because the product contains undeclared milk. The recall affects retailers in New York.

    Product
    BISCUIT FOOD Cheese Biscuits, The product comes in a 16.5 oz. (468g), clear plastic package. The product UPC codes 6926145714029 and 6926145712902. Manufacturer: Dongguan Jiayou Food Co., Ltd. Product of China.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2154-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

    Sun Med, LLC is recalling 110 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially detaching the port and impacting air delivery to the patient.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126F
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2191-2018·2018-06-20

    Angiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxin Risk

    Angiodynamics Inc. is recalling 20 boxes of Bio-Stable 5F kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2200-2018·2018-06-20

    Angiodynamics Recalls RS TANDEM 5F DL XPP Kits Due to Endotoxins

    Angiodynamics Inc. is recalling 7 units of RS TANDEM 5F DL XPP kits because components may contain unsafe levels of bacterial endotoxins.

    Product
    RS TANDEM 5F DL XPP, Catalog Number 60M019881
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2224-2018·2018-06-20

    Angiodynamics Recalls BioFlo PICC Kits Due to Bacterial Endotoxins

    Angiodynamics Inc. is recalling BioFlo PICC nursing kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-038
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Drugs)·D-0859-2018·2018-06-20

    Bocchi Labs Recalls Acne Shave Post-Shave Moisturizer Due to Bacterial Contamination

    Shadow Holdings DBA Bocchi Labs is recalling Acne Shave Post-Shave Moisturizer because products may be contaminated with bacteria due to CGMP deviations.

    Product
    Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5%, 3.3 FL OZ (98 mL) tube, Distributed by: United Exchange Corp., 17211 Valley View Blvd., Cerritos, CA 90703 USA, UPC 7 80707 73112 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2209-2018·2018-06-20

    Angiodynamics Recalls RS 5F DL BIOFLO PASV Kits Due to Endotoxins

    Angiodynamics Inc. is recalling 2 boxes of RS 5F DL BIOFLO PASV kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    RS 5F DL BIOFLO PASV, Catalog Number 60M161567
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2186-2018·2018-06-20

    Roche Recalls Accu-Chek Performa Test Strips Due to Potential Measurement Errors

    Roche Diabetes Care is recalling Accu-Chek Performa test strips because they may produce biased results or fail to detect blood samples, potentially leading to incorrect user actions.

    Product
    Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product Usage: The Accu-Chek Performa test strips are for use with the Accu-Chek Performa meter to quantitatively measure glucose (sugar) in venous whole blood or fresh capillary whole…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1560-2018·2018-06-20

    H-E-B Orange Sherbet Recalled for Potential Broken Metal Pieces

    H-E-B is recalling Creamy Creations No Sugar Added Orange Sherbet quarts because they may contain broken metal pieces.

    Product
    HEB Creamy Creations No Sugar Added Orange Sherbet quart
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2058-2018·2018-06-20

    Zeiss Laser Scanning Microscopes Recalled for Potential Laser Shutter Failure

    Zeiss is recalling specific laser scanning microscopes because the laser shutter may not close completely, allowing reflected beams to exceed Class I safety limits.

    Product
    Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes. Laser scanning microscopes are used in cell biology research.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2147-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Potential Port Detachment

    Sun Med, LLC is recalling 60 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach during use.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1116F
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2187-2018·2018-06-20

    Roche Recalls Accu-Chek Inform II Test Strips Due to Potential Errors

    Roche Diabetes Care is recalling Accu-Chek Inform II test strips because they may produce errors or biased results, potentially leading to incorrect user actions.

    Product
    Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product Usage: The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2190-2018·2018-06-20

    Angiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxin Risk

    Angiodynamics Inc. is recalling Bio-Stable 5F kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871
    Category
    Medical Device
    Distribution
    34 states