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.

16276–16300 of 53092

  • HighFDA (Devices)·Z-1554-2022·2022-08-24

    Surgical forceps recalled due to potentially compromised sterile barrier

    Stradis Medical recalls 850 surgical forceps (NARMD MEDICAL DEPOT Forceps, part ZZ-0701) due to potentially compromised sterile barriers. Healthcare facilities with these units should identify affected lot numbers and contact the manufacturer for guidance.

    Product
    NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"; Part Number: ZZ-0701
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1354-2022·2022-08-24

    Injectable ketorolac tromethamine recalled nationwide for potential cross-contamination

    Nephron Pharmaceuticals is recalling Ketorolac Tromethamine Injection due to manufacturing deviations that could lead to cross-contamination. The recall affects 5,040 vials distributed nationwide.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1351-2022·2022-08-24

    Prescription cancer drug lot recalled for failed quality specifications

    Zydus Pharmaceuticals recalls Fulvestrant Injection lot B200076 due to failed purity and stability specifications. Distributed nationwide; expiration January 31, 2024.

    Product
    FULVESTRANT — FULVESTRANT (FULVESTRANT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1541-2022·2022-08-24

    Skin liquid bandage recalled for improper temperature storage

    Family Dollar's NEW SKIN Liquid Bandage was not stored in temperature-controlled conditions, potentially compromising product integrity. Affected units were sold nationwide during May through June 2022.

    Product
    NEW SKIN LIQUID BANDAGE CLEAR .3FL OZ, SKU 999417
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1553-2022·2022-08-24

    Surgical forceps recalled due to compromised sterile barrier

    Stradis Medical is recalling NARMD MEDICAL DEPOT Kelly Straight forceps because the sterile barrier may be compromised. The recall affects 825 units distributed nationwide in South Carolina.

    Product
    NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1561-2022·2022-08-24

    Buckwheat Flour Recalled Due to Plastic Contamination

    Minn Dak Growers recalls Fancy Buckwheat Flour due to plastic foreign material contamination. Two lot numbers were distributed in Indiana; affected consumers should discard the product.

    Product
    Fancy Buckwheat Flour, Item #327, 50 lbs. net wt, Packed by Min-Dak Growers Grand Forks, ND - Product of the USA. Manufactured for Enjoy Life Foods.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1528-2022·2022-08-24

    Veriquick Pregnancy Test 2CT Recalled for Improper Storage

    Family Dollar is recalling Veriquick Pregnancy Test 2CT kits (SKU 903756) sold from May 1 to June 10, 2022 due to improper storage outside temperature-controlled areas.

    Product
    Veriquick Pregnancy Test 2CT, SKU 903756
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1538-2022·2022-08-24

    Fixodent denture adhesive cream recalled for improper storage

    Family Dollar is recalling Fixodent Org Cream denture adhesive (2.4oz and 0.75oz travel sizes) sold May-June 2022 due to improper storage in non-temperature-controlled areas. No illnesses reported.

    Product
    FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1361-2022·2022-08-24

    PrednisoLONE Oral Solution Recalled for Defective Container Seals

    Akorn, Inc. is recalling 14,712 bottles of PrednisoLONE Oral Solution (15 mg/5 mL) due to incomplete induction seals in containers. No illnesses have been reported, but the defect may affect product integrity.

    Product
    PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1550-2022·2022-08-24

    Factor Shrimp & Asparagus Risotto Recalled for Glass Contamination in Rice

    Factor Shrimp & Asparagus Risotto with pesto green beans is being recalled because the arborio rice ingredient contains glass. Consumers should not consume this product.

    Product
    Factor Shrimp & Asparagus Risotto with pesto green beans 14.2oz.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-1355-2022·2022-08-24

    Avant Foaming Hand Sanitizer Recalled Due to Manufacturing Process Deviation

    Aire-Master of America Inc. is recalling Avant Foaming Hand Sanitizer because the deionized water system used in manufacturing lacked appropriate microbial control measures.

    Product
    Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufactured for B4 Brands, Lisbon, Iowa 62253
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-1346-2022·2022-08-24

    Injectable Bupivacaine Recalled Due to Manufacturing Cross-Contamination Risk

    Nephron Sterile Compounding Center is recalling 2,030 bags of injectable bupivacaine due to potential cross-contamination from manufacturing process defects. No illnesses have been reported.

    Product
    PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-970-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1556-2022·2022-08-24

    FDA Recalls Echelon-14 Microcatheters Due to Moisture-Exposed Packaging

    Micro Therapeutics is recalling Echelon-14 microcatheters whose outer carton packaging was exposed to a wet substance during transport, posing a risk to device sterility.

    Product
    Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1557-2022·2022-08-24

    Echelon-14 Micro Catheter Recall Due to Moisture Exposure During Transport

    Micro Therapeutics is recalling Echelon-14 Micro Catheters because outer packaging was exposed to moisture during transport. The moisture exposure could compromise the sterility or function of the device.

    Product
    Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1546-2022·2022-08-24

    Factor Sweet Pea Risotto recalled for glass in rice ingredient

    Factor is recalling 849 units of Sweet Pea Risotto & Roasted Brussel Sprouts due to glass fragments in the arborio rice ingredient. No illnesses have been reported.

    Product
    Factor Sweet Pea Risotto & Roasted Brussel Sprouts 17.6 oz.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1518-2022·2022-08-24

    Abbott Alinity m Diagnostic System Recalled for Incorrect Optical Calibration

    Abbott Molecular is recalling the Alinity m System due to incorrect optical calibration. The affected unit (Serial Number 00654) was distributed to Italy.

    Product
    The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1549-2022·2022-08-24

    Factor Ready-to-Eat Meals Recalled Due to Glass in Arborio Rice

    Factor is recalling 10,545 units of Summertime Filet & Sweet Corn Risotto meals (best-by 07/20/2022) because the arborio rice ingredient contains glass fragments.

    Product
    Factor Summertime Filet & Sweet Corn Risotto with Sweet Peach-Berry Crumble & Zucchini Medley 15.2oz.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1560-2022·2022-08-24

    Sweet Loren's Place and Bake Sugar Cookie Dough Recalled for Undeclared Gluten

    Sweet Loren's Place and Bake Sugar Cookie Dough labeled as gluten-free has been recalled because it actually contains gluten. This poses a risk to consumers with celiac disease or gluten sensitivity.

    Product
    Sweet Loren's Place and Bake Sugar Cookie Dough, Net Wt. 12 oz.
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-1548-2022·2022-08-24

    Medical dressing tray mislabeled as latex-free but contains natural rubber latex

    Trinity Sterile's IV catheter dressing trays are mislabeled as latex-free despite containing natural rubber latex in component 94-7002, risking allergic reactions in latex-sensitive users.

    Product
    Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-08232022-01·2022-08-23

    Perdue Frozen Gluten-Free Chicken Tenders Alerted for Foreign Material Contamination

    USDA issued a public health alert for Perdue frozen gluten-free chicken tenders due to potential contamination with plastic and blue dye. No illnesses have been reported.

    Product
    Perdue Foods LLC — FSIS Issues Public Health Alert for Perdue Frozen Ready-To-Eat Chicken Tender Products Due to Foreign Material Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·22V636000·2022-08-23

    Indian FTR 1200 S Motorcycles Recalled for Coolant Junction Leak Risk

    Indian Motorcycle Company is recalling certain FTR 1200 and FTR 1200 S motorcycles due to a coolant junction that may leak, posing burn and crash risks to riders.

    Product
    INDIAN — INDIAN FTR1200, FTR 1200 S, FTR 1200 RALLY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22E070000·2022-08-23

    Firefly Recalls Multiplex Electronic Control Modules for Unintended Awning Movement

    Firefly Integrations is recalling certain Multiplex Electronic Control Modules (ECM) because software defects may cause vehicle awnings to move unintentionally while parked, increasing the risk of injury.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V635000·2022-08-19

    Indian Motorcycle Recalls 28,689 Models for Electrical Connection Failure

    Indian Motorcycle is recalling 28,689 motorcycles from 2014-2020 because a failing electrical connection may cause loss of front lights, increasing crash risk.

    Product
    INDIAN — INDIAN CHIEFTAIN DARK HORSE, CHIEFTAIN, CHIEF VINTAGE, SPRINGFIELD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V633000·2022-08-18

    2020-2022 Hyundai Palisade vehicles recalled for tow hitch fire

    Hyundai is recalling 2020-2022 Palisade vehicles with tow hitch harnesses that may accumulate debris and moisture, causing electrical shorts and fire risk. Dealers will install replacement fuses and wire kits.

    Product
    HYUNDAI — HYUNDAI PALISADE
    Category
    Vehicle
    Distribution
    Distributed nationwide