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.

15276–15300 of 53092

  • HighFDA (Devices)·Z-0312-2023·2022-11-30

    Neurosurgery convenience kits recalled due to included recalled surgical drapes

    ROi CPS LLC is recalling 248 regard NEURO TRAY neurosurgery convenience kits because they contain 3M surgical drapes that were previously recalled. The kits were distributed in LA, MO, NC, and FL.

    Product
    regard NEURO TRAY, NU00160R, Item Number 880158018; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0300-2023·2022-11-30

    Regard Retinal Pack surgical kits recalled for defective 3M drapes

    ROi CPS LLC is recalling Regard Retinal Pack surgical kits distributed in Louisiana, Missouri, North Carolina, and Florida because they contained recalled 3M surgical drapes.

    Product
    regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0304-2023·2022-11-30

    Hip Arthroplasty Surgical Convenience Kits Recalled Due to Defective 3M Drapes

    ROi CPS LLC is recalling regard TOTAL HIP ARTHROPLASTY surgical convenience kits containing recalled 3M surgical drapes distributed to facilities in Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0292-2023·2022-11-30

    Neurosurgery Kits Recalled Due to Defective 3M Surgical Drapes

    ROi CPS LLC is recalling 38 neurosurgery convenience kits distributed in four states because they contain 3M surgical drapes that were separately recalled.

    Product
    regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0266-2023·2022-11-30

    Allison Medical recalls InControl insulin syringes for incorrect needle gauge labeling

    Allison Medical is recalling 150,000 InControl insulin syringes distributed in Texas due to incorrect package labeling of needle gauge. The mislabeled packages may lead patients to unknowingly select the wrong needle size.

    Product
    InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0280-2023·2022-11-30

    Visionsense Infrared Microscope Recalled Due to Optical Fiber Cable Damage

    Visionsense is recalling 205 units of its VS3 Iridium microscope because optical fiber cables may become damaged during handling, causing loss of function and outer cable heating or melting.

    Product
    VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0279-2023·2022-11-30

    Surgical Blade Safety Cartridges Recalled Due to Missing Sterilization

    Southmedic is recalling 450 units of sterile surgical blade cartridges (Lot W92761) because the product was not sterilized but was labeled and distributed as sterile. Non-sterile surgical blades could cause infection if used on patients.

    Product
    Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0288-2023·2022-11-30

    Surgical Convenience Kits Recalled Due to Defective 3M Surgical Drapes

    ROi CPS LLC is recalling regard BASIC NEURO surgical convenience kits containing 3M surgical drapes that were previously recalled. Affected units were distributed to LA, MO, NC, and FL.

    Product
    regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-0167-2023·2022-11-30

    Tomato Head Beet Hummus Recalled for Potential Metal Fragments

    Tomato Head Foods is recalling Tomato Head Beet Hummus in 8oz cups due to potential metal fragments in the product. The recalled product was distributed to distribution centers in California, Florida, Georgia, and Illinois.

    Product
    The Tomato Head Beet Hummus packaged in 8oz PPE plastic cups - 8 cups per case
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0308-2023·2022-11-30

    Surgical convenience kits recalled for defective 3M drape components

    ROi CPS LLC recalls 213 surgical convenience kits containing 3M surgical drapes that were subsequently recalled. The affected kits were distributed in Louisiana, Missouri, North Carolina, and Florida.

    Product
    ¿regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0302-2023·2022-11-30

    Surgical Convenience Kits with Recalled 3M Surgical Drapes

    ROi CPS LLC is recalling 21 surgical convenience kits distributed to Louisiana, Missouri, North Carolina, and Florida because they contain 3M surgical drapes that were subsequently recalled.

    Product
    regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0265-2023·2022-11-30

    B. Braun Central Venous Catheter Tray Recalled for Incorrect Expiration Date Label

    Medical Action Industries is recalling 240 cases of B. Braun CARESITE Port Access Kits (REF 375214) due to incorrect expiration date labeling. The kits show an expiration date of 02/21/2024 when the actual expiration is 02/10/2024.

    Product
    B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0298-2023·2022-11-30

    Surgical Convenience Kits Recalled Due to Recalled Surgical Drapes

    Regard ACDF surgical convenience kits containing 3M surgical drapes that were subsequently recalled are being recalled by ROi CPS LLC. Approximately 30 kits were distributed in Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0291-2023·2022-11-30

    Surgical convenience kits recalled due to included recalled 3M drapes

    Surgical convenience kits (regard NEURO PACK) were recalled because they contain 3M surgical drapes that are subject to a separate recall. Affected units were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0260-2023·2022-11-30

    3M Steri-Drape surgical drape recalled for adhesive skin injuries

    3M recalls specific batches of Steri-Drape surgical drapes due to reported adhesive-related skin injuries and potential product damage from difficult-to-remove adhesive liners.

    Product
    3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·22V884000·2022-11-29

    Winnebago travel trailers recalled for incorrect cargo capacity labels

    Winnebago is recalling certain 2021-2022 Minnie and Voyage travel trailers due to incorrect cargo carrying capacity labels, which could lead to vehicle overloading and loss of control.

    Product
    WINNEBAGO — WINNEBAGO MINNIE, VOYAGE!
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V882000·2022-11-29

    Travel trailer LP gas fittings may crack and leak, risking fire

    Holiday House is recalling 2021–2022 travel trailers because the quick disconnect fittings in the LP gas system may be cracked, causing gas leaks that could lead to fires. Owners should contact Holiday House for inspection and free replacement.

    Product
    HOLIDAY HOUSE — HOLIDAY HOUSE 18RB, 27RQ, 24TB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22C007000·2022-11-28

    Marainbow Portable Infant Safe Seat Recall for Incorrect Installation Labels

    JD E-Commerce America Limited is recalling Marainbow Portable Infant Safe Seats because incorrect installation labels and design flaws prevent proper installation, increasing crash injury risk.

    Product
    CHILD SEAT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0154-2023·2022-11-23

    Pedialyte Unflavored Electrolyte Solution Recalled for Seal Integrity Issues

    Abbott Laboratories is recalling Pedialyte Unflavored Electrolyte Solution 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. The recall affects 14,588,544 bottles distributed in the US and internationally.

    Product
    Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case
    Category
    Drug
    Distribution
    50 states
  • HighFDA (Devices)·Z-0205-2023·2022-11-23

    CareFusion Genesis STERRAD containers fail sterilization testing

    Healthcare sterilization containers failed aerosol challenge testing, indicating potential inadequate sterilization of surgical instruments. 493 units affected across US and international markets.

    Product
    CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD1-4ST
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·22V874000·2022-11-23

    2021-2022 Chevrolet Heavy-Duty Trucks Recalled for Suspension Lock Nut Defect

    General Motors is recalling 2021-2022 Chevrolet 4500HD/5500HD/6500HD and XD models due to improperly heat-treated hex flange lock nuts in suspension and steering joints. The defective nuts may break, causing steering instability and increasing crash risk.

    Product
    CHEVROLET — CHEVROLET 4500HD, 5500XD, 4500XD, 6500HD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0159-2023·2022-11-23

    Similac 360 Total Care Sensitive infant formula recalled due to compromised seal integrity

    Abbott Laboratories is recalling Similac 360 Total Care Sensitive infant formula due to compromised seal integrity that could lead to spoilage. Affected consumers should not use the product and contact Abbott for further instructions.

    Product
    Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packaged as: 4 - 6 count carton
    Category
    Food
    Distribution
    50 states
  • HighFDA (Devices)·Z-0207-2023·2022-11-23

    CareFusion Genesis Sterilization Containers Fail Required Aerosol Challenge Testing

    CareFusion Genesis sterilization containers failed to meet aerosol challenge testing requirements and may not properly sterilize medical instruments.

    Product
    CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD1-6ST
    Category
    Medical Device
    Distribution
    0 states