The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

5576–5600 of 21589

  • ModerateFDA (Devices)·Z-1829-2021·2021-06-16

    VIA Microcatheter VIA 21 Recalled for International Labeling Error

    MICROVENTION INC. is recalling VIA Microcatheter VIA 21 units (Lot 19110403M) because they were shipped with international labeling instead of FDA-cleared US labeling.

    Product
    VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0605-2021·2021-06-16

    DELFLEX Peritoneal Dialysis Solution Recalled for Temperature Abuse

    Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution nationwide because the product was exposed to temperatures outside specified limits during distribution, which may compromise sterility or safety.

    Product
    DELFLEX — DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0630-2021·2021-06-16

    Levetiracetam Tablets 250 mg Recalled for Incorrect Barcode

    McKesson Corporation is recalling Levetiracetam Tablets USP 250 mg due to a barcode error that could cause some units to be misread as Naproxen 500 mg, although the product label itself is correct.

    Product
    Levetiracetam Tablets USP, 250 mg UD 100 Tablets (10x10) boxes, Rx Only, Distributed By: McKesson Corporation 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 090, India NDC 63739-795-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0603-2021·2021-06-16

    Sodium Chloride 0.9% USP 1000 mL Recall for Temperature Abuse

    Fresenius Medical Care is recalling Sodium Chloride 0.9% USP 1000 mL injection (Lot #20NG02095, expiration October 2021) because the product was exposed to temperatures outside specified limits, which may affect its sterility and safety.

    Product
    Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1835-2021·2021-06-16

    Medical microscope slide stainer recalled due to defective pump tubing

    Hardy Diagnostics is recalling the Quickslide GramPro 1 Automated Gram Stanier due to defective tubing in the pump mechanism that could cause device malfunction.

    Product
    Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·21V448000·2021-06-14

    Utilimaster Velocity Recalled for Incorrect Seating Capacity Placard

    Shyft Group is recalling 2021 Utilimaster Velocity vehicles because the tire and loading placard incorrectly states a seating capacity of one instead of two.

    Product
    UTILIMASTER — UTILIMASTER VELOCITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0600-2021·2021-06-09

    Micardis (Telmisartan) 80 mg Tablets Recall Due to Subpotency

    Boehringer Ingelheim Pharmaceuticals is recalling Micardis 80 mg tablets (Lot #860412, expiration September 2022) because the tablets contain less active ingredient than required. This is a voluntary Class II recall.

    Product
    Micardis Tablets, (telmisartan Tablets) 80 mg, 30 ct. per folding cartons, Rx only, NDC 0597-0041-37), Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877
    Category
    Drug
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1790-2021·2021-06-09

    Terumo Sarns Temperature Control Devices Recalled for Cleaning Protocol Validation Issues

    Terumo is recalling Sarns Temperature Control Monitor units (1,176 devices) because it cannot validate a cleaning protocol meeting current FDA requirements. Users should discontinue use and dispose of affected devices immediately.

    Product
    The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. The TCM with options will also supply water for cardioplegia, free
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1699-2021·2021-06-09

    NexSite HD hemodialysis catheter directions for use consistency recall

    MARVAO MEDICAL DEVICES is correcting the Directions for Use (DFU) for NexSite HD hemodialysis catheters to ensure consistency between field documentation and website information for 292 devices distributed in the U.S.

    Product
    NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1695-2021·2021-06-09

    K2M Cascadia AN Interbody Implants Recalled for Mislabeled Dimensions

    K2M, Inc is recalling Cascadia AN Interbody Convex lumbar implants with mislabeled product dimensions. The affected sizes include 10x22x14mm, 10x28x14mm, and 10x22x15mm. No injuries have been reported.

    Product
    Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0647-2021·2021-06-09

    Lipodrene With 25mg Ephedra Extract recalled for unapproved food additive

    Hi Tech Pharmaceuticals is recalling Lipodrene With 25mg Ephedra Extract because the product contains 1,4-dimethylamylamine (DMAA), an unapproved food additive.

    Product
    Lipodrene With 25mg Ephedra Extract 100CT UPC 8 57084 00056 9
    Category
    Drug
    Distribution
    38 states
  • ModerateFDA (Food)·F-0649-2021·2021-06-09

    Genpak Bake n Show Muffin Trays Recalled for Foreign Objects

    Genpak is recalling Bake n Show Muffin Trays in three sizes due to the discovery of foreign objects in product packaging. The recall affects units distributed across multiple US states and Canada.

    Product
    Bake n Show¿ Muffin Tray 4 Cavity Large, Bake n Show¿ Muffin Tray 4 Cavity Large Shallow & Bake n Show¿ Muffin Tray 6 Cavity
    Category
    Consumer Product
    Distribution
    24 states
  • ModerateFDA (Food)·F-0651-2021·2021-06-09

    Genpak Bake n Show Cake Trays Recalled for Foreign Objects

    Genpak is recalling Bake n Show Round and Square Cake Trays due to the presence of foreign objects found in product packaging. The trays were distributed across multiple U.S. states and Canada.

    Product
    Bake n Show¿ Cake Tray Round & Bake n Show¿ Cake Tray Square
    Category
    Consumer Product
    Distribution
    24 states
  • ModerateFDA (Food)·F-0650-2021·2021-06-09

    Bake n Show Pizza Cookie Tray recalled for foreign objects

    Genpak is recalling Bake n Show Pizza Cookie Trays (12") because foreign objects were found in product packaging. The recall affects multiple states and Canada.

    Product
    Bake n Show¿ Pizza Cookie Tray 12"
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Food)·F-0648-2021·2021-06-09

    Genpak Bake n Show Angel Food Trays Recalled for Foreign Objects

    Genpak is recalling Bake n Show Angel Food Trays (8-inch and 8-inch shallow models) because foreign objects were found in the product packaging. Consumers should stop using affected trays.

    Product
    Bake n Show¿ Angel Food Tray 8 Inch & 8 inch shallow
    Category
    Consumer Product
    Distribution
    24 states
  • ModerateFDA (Food)·F-0644-2021·2021-06-09

    Wegmans Everything Bagel Hummus Recalled for Hard Plastic Fragments

    Wegmans Food You Feel Good About Everything Bagel Seasoned Hummus may contain pieces of hard black plastic. The product was distributed in Massachusetts, New York, Pennsylvania, New Jersey, Maryland, Virginia, and North Carolina.

    Product
    Wegmans Food You Feel Good About Everything Bagel Seasoned Hummus, 8oz packaged in a clear plastic container with a clear plastic snap lid
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·F-0654-2021·2021-06-09

    Wegmans Bagged Ice Recalled for Possible Metal Fragment Contamination

    Wegmans Food Markets is recalling its 7-pound bagged ice products due to possible contamination with metal fragments. The recall affects products distributed in New York, Massachusetts, and Pennsylvania.

    Product
    Wegmans brand Bagged Ice, 7lb, packaged in a clear plastic bag
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0652-2021·2021-06-09

    Genpak Bake n Show Oven Ready Food Trays recalled for foreign objects

    Genpak is recalling Bake n Show Oven Ready Food Trays (16 ounce) due to foreign objects found in the packaging. The affected product was distributed across multiple U.S. states and Canada.

    Product
    Bake n Show¿ Oven Ready Food Tray 16 ounce
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Drugs)·D-0540-2021·2021-06-02

    Cardinal Health Recalls HySept Solution Due to Temperature Excursions

    Cardinal Health is recalling 236 bottles of HySept Solution 0.25% Sodium Hypochlorite due to intermittent temperature excursions during storage.

    Product
    HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.) NDC 39328-063-25 Manufactured in USA Patrin Pharma, Skokie, IL 60076
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0580-2021·2021-06-02

    Cardinal Health Recalls Levalbuterol Inhalers Due to Temperature Excursions

    Cardinal Health is recalling 828 Levalbuterol tartrate HFA inhalers distributed in Florida, Georgia, and South Carolina due to intermittent temperature excursions during storage.

    Product
    LEVALBUTEROL TARTRATE HFA INHALATION — LEVALBUTEROL TARTRATE HFA INHALATION (LEVALBUTEROL TARTRATE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Food)·F-0566-2021·2021-06-02

    Kauffman's Sweet Apple Cider Recalled for Elevated Patulin Levels

    A L Kauffman & Sons Co. is recalling 1,740.5 gallons of Sweet Apple Cider due to elevated levels of patulin. The product was distributed in PA, MD, TN, and NJ.

    Product
    Kauffman's Fruit Farm & Market Sweet Apple Cider; Keep Refrigerated; Packaged in plastic bottles with screw-cap lids in the following sizes: 12-once: 25 bottles per case. 1/2-gallon: 9 bottles per case 1-gallon: 4 bottles per case. 350-gallon tote 250-gallon tote
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0411-2021·2021-06-02

    Cardinal Health Recalls COSOPT Eye Drops Due to Temperature Excursions

    Cardinal Health Inc. is recalling 12 bottles of COSOPT ophthalmic solution due to intermittent temperature excursions during storage.

    Product
    COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolamide Hydrochloride 22.3 mg/mL Timolol Maleate 6.8 mg/mL) 10ML Ocumeter Plus Ophthalmic Dispenser Sterile Ophthlamic Solution Rx only NDC/UPC 174780-605-10 Distributed by: Akorn, Inc. Lake Forest, IL 60
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1679-2021·2021-06-02

    Nobel Biocare Implant Crown Recalled for Manufacturing Specification Defects

    Nobel Biocare Procera LLC is recalling specific implant crown units because they were not manufactured to specification. The recall affects units distributed in the US and several international countries.

    Product
    NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77363
    Category
    Medical Device
    Distribution
    Distributed nationwide