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.

28226–28250 of 50488

  • HighFDA (Devices)·Z-2542-2018·2018-08-01

    Life Technologies Recalls Gibco CTS OpTmizer T Cell Expansion Medium

    Life Technologies is recalling Gibco CTS OpTmizer T Cell Expansion Serum Free Medium due to compromised fill port tube seals that may allow mold growth.

    Product
    Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2539-2018·2018-08-01

    Ad-Tech Drill Sleeve Guides Recalled Due to Raw Material Tolerance Defect

    Ad-Tech Medical Instrument Corporation is recalling 65 Drill Sleeve Guides because raw material diameter was under tolerance, which could cause drill bits to seize during surgery.

    Product
    AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from vendor 00-0001062., AD0021502, AD0021628. Product Usage: The drill sleeve guides are accessories to the Ad-Tech Cranial Drill Bits. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1680-2018·2018-08-01

    Biscomerica Caramel Sea Salt Chocolate Chip Cookies Recalled for Milk Allergen Mislabeling

    Biscomerica, Inc. is recalling Sweet Serenity Caramel Sea Salt Chocolate Chip Cookies because the packaging fails to list milk in the 'contains' statement, despite milk being an ingredient.

    Product
    Sweet Serenity Caramel Sea Salt Chocolate Chip Cookies, with caramel flavored chips; NET WT; 2 oz. UPC: 0 31535 59962 2 Manufactured by Biscomerica Corp, Rialto, CA Ingredients: Enriched unbleached flour (wheat flour, niacin, reduced iron, thiamine mononitrate {Vitamin…
    Category
    Food
    Distribution
    22 states
  • HighFDA (Food)·F-1674-2018·2018-08-01

    Papa John's Superfood Salad Kit Recalled for Peanut Mislabeling

    Papa John's Salads & Produce is recalling Superfood Salad Kits because peanuts were packed instead of cashews, creating an undeclared allergen hazard.

    Product
    Superfood Salad Kit - 6.8 lbs. - sold to Kroger owned stores and prepared and purchased at deli department at retail stores. Size purchased is dependent on customer order. 6.8 lb. kit UPC: 7 82796 0174 3 Fry's, King Sooper;Smith's Food and Drug: UPC 2541465XXXX - last 4…
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-1661-2018·2018-08-01

    Kowalski's Markets kalbi rub recalled for undeclared wheat

    J and J Bunting, Inc. is recalling Kowalski's Markets kalbi rub because it contains wheat, which is not declared on the label.

    Product
    Kowalski's Markets kalbi rub. Net Wt 5.5 oz. (155.9 g), UPC 79147-00243. Distributed by: Kowalski's Markets, Woodbury, MN 55125
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2532-2018·2018-08-01

    Ethicon Recalls PDS Plus Antibacterial Sutures Due to Tensile Strength Defect

    Ethicon, Inc. is recalling specific lots of PDS Plus Antibacterial Sutures because they do not meet tensile strength specifications.

    Product
    PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G (GTIN 10705031203983)
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·18197·2018-08-01

    BMC Recalls Timemachine 01 Bicycles Due to Front Wheel Clearance Fall Hazard

    BMC is recalling about 430 Timemachine 01 bicycles because insufficient space between the front wheel and downtube poses a fall hazard. Four fall incidents were reported, including one broken finger.

    Product
    Timemachine 01 bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1773-2018·2018-08-01

    AMPI Recalls Whey Powder Due to Potential Salmonella Contamination

    AMPI is recalling specific lots of whey powder because they may be contaminated with Salmonella. The product was distributed to nine states.

    Product
    AMPI Whey Powder, Sweet Type, Formula 521, Extra Grade, spray process pasteurized, packaged in 50 lbs net (22.68 kg net) and 25 kg net (55.12 lbs net).
    Category
    Food
    Distribution
    9 states
  • HighNHTSA·18E074000·2018-08-01

    H&H Sports Recalls VCAN V531 Motorcycle Helmets Due to Strap Defect

    H&H Sports Protection is recalling VCAN V531 motorcycle helmets because the straps may not be properly sewn, potentially failing to stay secured during a crash.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2535-2018·2018-08-01

    Elekta Recalls HexaPOD evo RT Couch Top for Positioning Errors

    Elekta, Inc. is recalling 725 HexaPOD evo RT Couch Top devices because they may tilt incorrectly after specific workflows, leading to improper patient positioning during radiation therapy.

    Product
    HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system. Product Usage: To support and aid in positioning a patient during radiation therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2544-2018·2018-08-01

    Life Technologies Recalls Gibco DMEM Tissue Culture Medium Due to Seal Defect

    Life Technologies is recalling Gibco DMEM tissue culture medium because compromised seal integrity may allow media to leak and grow mold.

    Product
    Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995115. Tissue and cell culture medium.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2543-2018·2018-08-01

    Life Technologies Recalls GIBCO CTS AIM V Serum-Free Media Due to Seal Defect

    Life Technologies is recalling 141 units of GIBCO CTS AIM V Serum-Free Media because compromised seal integrity may allow media to leak and grow mold.

    Product
    GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture medium.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2549-2018·2018-08-01

    FDA Recalls Prevent G Safety Winged Blood Collection Sets Due to Leaks

    Guangzhou Improve Medical Instruments Co., Ltd. is recalling 200,000 Prevent G Safety Winged Blood Collection Sets in Kansas due to leak complaints.

    Product
    Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2537-2018·2018-08-01

    Forte Automation Patient Positioning System Recalled for Communication Failures

    Forte Automation Systems is recalling 13 patient positioning systems in California due to periodic communication failures with the accuracy filter that may not be indicated to the operator.

    Product
    Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2546-2018·2018-08-01

    Life Technologies Recalls Gibco RPMI 1640 Medium Due to Seal Integrity Issues

    Life Technologies is recalling Lot 1930752 of Gibco RPMI 1640 Medium because compromised fill port tube seals may allow media to leak and mold to grow.

    Product
    Gibco RPMI 1640 Medium, Model Number 61870150. Tissue and cell culture medium.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Food)·F-1669-2018·2018-08-01

    H-E-B Creamy Creations Ice Cream Cups Recalled for Metal Fragments

    H-E-B is recalling Creamy Creations Vanilla Chocolate Ice Cream Cups due to a potential risk of containing metal fragments.

    Product
    HEB Creamy Creations Vanilla Chocolate Cup 3 oz packaged in a 12 count plastic bag - (6-3oz. Chocolate Ice Cream cups and 6-3oz. Vanilla Ice Cream cups)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2527-2018·2018-08-01

    GE MR Surgical Suite Option Recalled for Patient Transfer Mechanism Defect

    GE Medical Systems is recalling 54 MR Surgical Suite Option units because a defect in the table transfer release may cause an unexpected loss of function in the patient transfer mechanism.

    Product
    MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa¿ 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used to produce head and whole body magnetic resonance images that are high resolution high signal-to-noise…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2557-2018·2018-08-01

    Roche Recalls cobas m 511 Hematology Analyzer for Discrepant Results

    Roche Diagnostics Hematology is recalling 17 cobas m 511 integrated hematology analyzers due to discrepant results in patients with severe microcytic anemia.

    Product
    cobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The cobas m 511 integrated hematology analyzer is a quantitative, automated analyzer with cell locating capability. It is intended for in vitro diagnostic use by a skilled operator in the…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2545-2018·2018-08-01

    Life Technologies Recalls Gibco DMEM Tissue Culture Medium Due to Seal Defect

    Life Technologies is recalling 91 units of Gibco DMEM tissue culture medium because compromised fill port seals may allow media to leak and grow mold.

    Product
    Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175. Tissue and cell culture medium.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2526-2018·2018-08-01

    Siemens Artis zee Systems Recalled for Defective Cooling Unit Seals

    Siemens is recalling Artis zee angiography systems with specific Laird cooling units due to defective seals that may allow coolant to leak into electrical parts, potentially causing sudden system shutdowns.

    Product
    Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-1668-2018·2018-08-01

    H-E-B Creamy Creations Sherbet Cups Recalled for Metal Fragments

    H-E-B is recalling Creamy Creations Orange and Lime Sherbet Cups due to a potential risk of containing metal fragments. The product was distributed in Texas.

    Product
    HEB Creamy Creations Orange and Lime Sherbet Cup 3 oz packaged in a 12 count plastic bag - (6-3oz. Orange Flavored Sherbet cups and 6-3oz. Lime Flavored Sherbet cups)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2533-2018·2018-08-01

    Ethicon Recalls PDS Plus Antibacterial Sutures for Tensile Strength Defects

    Ethicon, Inc. is recalling 756 units of PDS Plus Antibacterial Sutures because they do not meet tensile strength specifications. The affected products were distributed in Japan.

    Product
    PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1787-2018·2018-08-01

    Kerry Inc Recalls Soy Honey Cluster Due to Salmonella Risk

    Kerry Inc is recalling 165,600 lbs of Soy Honey Cluster distributed in Minnesota because an ingredient was processed on equipment linked to a salmonella outbreak.

    Product
    Soy Honey Cluster 30 lb. case, plastic bag in cardboard box Product code 30666529.137
    Category
    Food
    Distribution
    1 state