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.

15676–15700 of 53092

  • HighFDA (Devices)·Z-0079-2023·2022-10-19

    Scalpel Handle Recall: Hu-Friedy K360 Separates and Poses Choking Risk

    Hu-Friedy K360 scalpel handles may separate from the grip during use, allowing the tip to fall into a patient's mouth and cause cuts or choking.

    Product
    Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0051-2023·2022-10-19

    Freeman Pancreatic Flexi-Stent Kit Recalled for Mislabeled Expiration Date

    Hobbs Medical recalls Freeman Pancreatic Flexi-Stent Kit units with incorrect expiration dates on labels, extending apparent shelf life. Units distributed in the US and Canada, Austria, Belgium, Finland, and Norway from 2018–2020 are affected.

    Product
    Freeman Pancreatic Flexi-Stent Kit (containing 6533) Catalog Number: 6507
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0088-2023·2022-10-19

    Medline Venclose cardiovascular procedure kits recalled for wrong component size

    Medline Industries is recalling 1,760 Venclose procedure packs due to incorrect introducer/sheath component size. Affected kits contain 12cm components instead of the required 7cm.

    Product
    VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0012-2023·2022-10-19

    Hobbs Medical Flex-Ez Guide Wire With Incorrect Expiration Date

    Hobbs Medical Flex-Ez Guide Wire devices were labeled with an incorrect expiration date that extends shelf life beyond the intended duration. Affected devices were distributed in the US and internationally from March 2018 to September 2020.

    Product
    Hobbs Medical Flex-Ez Guide Wire Disposable For endoscopy procedures Ref: 3412
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0056-2023·2022-10-19

    Freeman Pancreatic Flexi-Stent Medical Device Recalled for Mislabeled Expiration Date

    Hobbs Medical recalls Freeman Pancreatic Flexi-Stent devices with incorrect expiration dates that extend shelf life, affecting devices distributed in the US and five other countries from 2018 to 2020.

    Product
    Freeman Pancreatic Flexi-Stent Catalog Number: 6534
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0078-2023·2022-10-19

    Olympus VC-10 Vacuum Curettage System Recalled for Incompatible Accessories

    Olympus recalls the VC-10 Vacuum Curettage System due to serious injury risk from incompatible collection canisters. The FDA warns users against using accessories not listed in the device's instructions.

    Product
    Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0049-2023·2022-10-19

    Freeman Pancreatic Flexi-Stent Kits recalled for incorrect expiration dates

    Hobbs Medical recalls Freeman Pancreatic Flexi-Stent Kits due to mislabeled expiration dates that may extend shelf life. Affected devices with lot numbers ending in R were distributed in the US and internationally from 2018-2020.

    Product
    Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0086-2023·2022-10-19

    Veritas Advanced Infusion Packs Recalled for Broken Irrigation Luer

    Johnson & Johnson Surgical Vision is recalling 53,624 units of Veritas Advanced Infusion Packs due to manufacturing defects causing broken or cracked irrigation luers that could compromise ophthalmic surgical procedures.

    Product
    Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0018-2023·2022-10-19

    Hobbs Medical Transbronchial Aspiration Needle Recalled for Incorrect Expiration Date

    Hobbs Medical recalls Transbronchial Aspiration Needle (Catalog 4621) for incorrect expiration dates extending shelf life. Affected devices distributed in the US and internationally from March 2018 to September 2020.

    Product
    Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0070-2023·2022-10-19

    Hobbs Medical Polypectomy Snare Incorrect Expiration Date Label Recall

    Hobbs Medical polypectomy snares have incorrect expiration dates on labels that extend the device shelf life beyond safe limits. Affected products distributed from March 2018 to September 2020 may be used past their intended expiration.

    Product
    Hobbs Medical Polypectomy Snare Catalog Number: 4575-OLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0035-2023·2022-10-19

    Ready Meals crab legs product recalled for undeclared fish allergen

    Albertsons Companies is recalling Ready Meals Snow Crab Legs Imitation Surimi in Oregon and Washington due to undeclared fish (anchovy) allergen. Consumers with fish allergies should not consume this product.

    Product
    Ready Meals Snow Crab Legs Imitation Surimi SCE NET WT 12 OZ CAL 300 NET WT. 0lb 12oz (340g) ready2eat Ingredients: Fish Protein (one or more Pollock, Pacific Whiting), Water, Lemon, Tomato Paste, What Starch, High Fructose Corn Syrup, Sugar, Egg Whites, Sorbitol, Crabmeat…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0026-2023·2022-10-19

    Medical device retrieval basket labels show incorrect expiration dates

    Hobbs Medical recalls the Helical Retrieval Basket due to labels displaying incorrect expiration dates that extend the device's shelf life. Affected units distributed worldwide from March 2018 to September 2020 may be used beyond their validated lifespan.

    Product
    Hobbs Helical Retrieval Basket Catalog Number: 4806
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0067-2023·2022-10-19

    Hobbs Medical Polypectomy Snare with Incorrect Expiration Date Label

    Hobbs Medical is recalling Polypectomy Snares (Catalog 7202) with incorrect expiration dates on labels, which could allow use of expired devices. Units were distributed in the US and several other countries from March 2018 to September 2020.

    Product
    Hobbs Medical Polypectomy Snare Catalog Number: 7202
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0050-2023·2022-10-19

    Freeman Pancreatic Flexi-Stent Kits Recalled Due to Incorrect Expiration Dates

    Freeman Pancreatic Flexi-Stent Kits are recalled due to device labels displaying incorrect expiration dates that extend shelf life. Affected units were distributed in the US and select countries from March 2018 to September 2020.

    Product
    Freeman Pancreatic Flexi-Stent Kits: Single Pigtail (containing 6544) Catalog Number: 6503
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0060-2023·2022-10-19

    Freeman Pancreatic Flexi-Stent Recall Due to Incorrect Expiration Date

    Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices due to incorrect expiration dates on product labels. The incorrect dates extend the shelf life, potentially allowing use beyond the actual safe expiration.

    Product
    Freeman Pancreatic Flexi-Stent Catalog Number: 6562
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0071-2023·2022-10-19

    COVID Test Kits Recalled for Incorrect Labeling and Device Incompatibility

    American Contract Systems is recalling COVID test kits incorrectly labeled for SARS-CoV-2 testing use. The 39,575 kits distributed in Pennsylvania should not be used with COVID devices.

    Product
    COVID Test Kit Nonsterile
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0032-2023·2022-10-19

    Hobbs Helical Retrieval Basket Recall Due to Incorrect Expiration Date Label

    Hobbs Medical is recalling Hobbs Helical Retrieval Basket (Catalog Number 4830) due to an incorrect expiration date on the device label. Affected devices have lot numbers ending in 'R' and were distributed in the US from March 2018 to September 2020.

    Product
    Hobbs Helical Retrieval Basket Catalog Number: 4830
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0074-2023·2022-10-19

    Yellowfin Tuna Round Steaks Recalled for Elevated Histamine Levels

    Worldwide Seafood Products LLC is recalling Tidal Seafood Yellowfin Tuna Round Steaks due to elevated histamine levels. The affected product was distributed to California, Texas, and New Mexico.

    Product
    Tidal Seafood Yellowfin Tuna Round Steaks 7 oz MED and LG Best Buy 6/17/2024 & 6/20/2024
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0046-2023·2022-10-19

    Freeman Pancreatic Flexi-Stent Kit recalled for incorrect expiration date labeling

    Hobbs Medical recalls the Freeman Pancreatic Flexi-Stent Kit due to incorrect expiration dates on product labels that extend shelf life. Affected devices were distributed to the US and international markets from March 2018 through September 2020.

    Product
    Freeman Pancreatic Flexi-Stent Kit (containing 6352) Catalog Number: 6321
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0023-2023·2022-10-19

    Hobbs Posi-Stop Injection Needle recalled for incorrect expiration date on label

    Hobbs Medical is recalling Posi-Stop Injection Needles (lot numbers ending in R) due to incorrect expiration dates on labels that extend shelf life. Affected devices were distributed in the US from March 2018 to September 2020.

    Product
    Hobbs Posi-Stop Injection Needle Catalog Number: 4718
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0027-2023·2022-10-19

    Hobbs Helical Retrieval Basket Recalled for Incorrect Expiration Date Labels

    Hobbs Medical is recalling Helical Retrieval Baskets with incorrect expiration dates that extend shelf life. Devices distributed from March 2018 through September 2020 may be used beyond their safe operating period.

    Product
    Hobbs Helical Retrieval Basket Catalog Number: 4808
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0020-2023·2022-10-19

    Hobbs Posi-Stop Injection Needle Recalled for Incorrect Expiration Date Labeling

    Hobbs Medical is recalling Hobbs Posi-Stop Injection Needles with certain lot numbers because device labels display an incorrect expiration date, extending the product's indicated shelf life.

    Product
    Hobbs Posi-Stop Injection Needle Catalog Number: 4702
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22E089000·2022-10-18

    Comoto Recalls Youth Helmets for Inadequate Impact Protection

    Comoto is recalling specific Bilt Grommet Youth helmets that may not adequately protect the wearer during a crash.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V781000·2022-10-18

    Harley-Davidson Touring and Trike Motorcycles Unintended Brake Light Illumination Recall

    Harley-Davidson is recalling certain 2019-2022 Touring, Trike, and CVO models due to a software error causing brake lights to illuminate without rider input. This malfunction may confuse other drivers and increase crash risk.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON FLTRXS, FLTRXSE, FLTRXST, FLHTCUTGSE
    Category
    Vehicle
    Distribution
    Distributed nationwide