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.

251–275 of 3531

  • ModerateFDA (Devices)·Z-1272-2025·2025-03-12

    Dental abutment implants recalled for incorrect patient chart stickers

    Hiossen Inc. is recalling ET Rigid Abutment (Mini) dental implant components due to patient chart stickers that incorrectly identify the product version. The stickers may identify Mini versions as Regular, or Multi-versions as Mini.

    Product
    ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4537MP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0603-2025·2025-03-12

    Noble Made Garlic Parmesan Wing Sauce recalled for foaming issue

    Noble Made Garlic Parmesan Wing Sauce is being recalled due to customer complaints of bottles foaming when opened. The product was distributed to retail locations across multiple states.

    Product
    Noble Made Garlic Parmesan Wing Sauce, net wt 9.25oz, UPC 850000398542, #0897 BEST BY 06/02/2026 14:02 33724 L1, Code: F20920061
    Category
    Food
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-1296-2025·2025-03-12

    BD BBL TB Stain Kit Expiration Date Labeling Discrepancy

    BD BBL TB Stain Kit component shipped with incorrect expiration date labeling. One component has printed expiration 30 September 2024 while Certificate of Analysis indicates 30 April 2025, creating confusion about product validity.

    Product
    BD BBL TB Stain Kit K, Catalog (REF): 212522
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1274-2025·2025-03-12

    Hiossen Dental Abutments Misidentified on Patient Chart Stickers

    Hiossen is recalling patient chart stickers for dental abutments that incorrectly identify product versions. Stickers mislabel ET Rigid Abutments as Regular and ET Multi Abutments as Mini. Dentists should verify actual product versions against packaging labels.

    Product
    Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA503RV1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1252-2025·2025-03-12

    Philips IntelliSpace Cardiovascular Software Data Archival Failure Recall

    Philips cardiovascular diagnostic software version 7.0.0.0 cannot archive, copy, or export study data, affecting 139 units distributed nationwide. Users may experience data management and workflow disruptions.

    Product
    Philips IntelliSpace Cardiovascular software, Model 830089.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1228-2025·2025-03-05

    BD PYXIS MEDBANK Medication Systems: Labeling Update for Operating Room Restriction

    CareFusion is updating labeling for BD PYXIS MEDBANK medication systems to include a contraindication against use in procedure and operating rooms. Healthcare facilities should review updated labeling and ensure appropriate device placement.

    Product
    155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD PYXIS MEDBANK MINI 1FH-2HH 138921-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 155159-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 169-101 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 139122-01 BD PYXIS MEDBANK MINI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1248-2025·2025-03-05

    Medical device recall: sterilization validator with incorrect incubation time

    TERRAGENE S.A. is recalling 914 ASP BIOTRACE Auto Read 60 sterilization process challenge devices due to incorrect incubation time listed in the product instructions. The IFU lists 20 minutes instead of the correct 60 minutes.

    Product
    ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1227-2025·2025-03-05

    BD PYXIS MEDBANK systems operating room contraindication labeling update

    BD PYXIS MEDBANK medication management systems are subject to a labeling update adding a contraindication against use in procedure and operating rooms. Approximately 6,075 units were distributed nationwide.

    Product
    138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115 BD PYXIS MEDBANK MINI CR-4HH-P 139001-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FH-P 139002-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FM-P 139000-01 BD PYXIS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1229-2025·2025-03-05

    BD PYXIS medication cabinets labeling update: operating room contraindication

    CareFusion is updating labeling for BD PYXIS medication management cabinets to add a contraindication statement prohibiting use in procedure and operating rooms.

    Product
    139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2HH-2FH-3FM 139041-01 BD PYXIS MEDFLEX MN 1000 2HH-2FM 139046-01 BD PYXIS MEDFLEX MN 1000 2HH-5FM 139038-01 BD PYXIS MEDFLEX MN 1000 3FM 139040-01 BD PYXIS MEDFL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·23V032000·2025-03-01

    2023 Winnebago Revel: incorrect tire size on safety label

    Certain 2023 Winnebago Revel camper vans have an incorrect tire size listed on the Tire and Loading Information Label (R16 instead of R17). Installing the wrong tires based on this incorrect information could increase the risk of a crash.

    Product
    WINNEBAGO — 2023 WINNEBAGO REVEL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0238-2025·2025-02-26

    Atomoxetine Capsules Recalled for Chemical Impurity Above FDA Limits

    Glenmark Pharmaceuticals is recalling 120,000 bottles of Atomoxetine 10 mg capsules nationwide due to N-nitroso Atomoxetine impurity exceeding FDA recommended limits. Multiple lot numbers are affected with expiration dates through July 2026.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0560-2025·2025-02-19

    Marionberry Jelly Sticks Recalled Due to Undeclared Food Additives and Dyes

    The Candy Basket Inc recalls Marionberry Jelly Sticks DARK due to undeclared food dyes and additives including Red #3, Blue #1, Potassium Sorbate, and Propylene Glycol.

    Product
    Marionberry Jelly Sticks DARK, item number CB745-D, is packed and sold in bulk 4lbs. boxes. Product does not have a UPC and is not repackaged for retail. Product was sold out of bulk chocolate cases from candy stores to consumers without any labeling. Label on bulk 4lbs. box d
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0535-2025·2025-02-19

    Nestle Toll House Cookie Dough Recalled Due to Improper Storage Conditions

    Target Corporation recalled Nestle Toll House Valentine's Chocolate Chip cookie dough (UPC 028000344085) due to improper storage temperature. The product was distributed in AK, CA, ID, MT, OR, and WA.

    Product
    Nestle Toll House Valentine's Chocolate Chip cookie dough, Makes 20 cookies. Net wt 14 oz. UPC 0 28000-34408 5. Distributed by Nestle USA, Arlington, VA 22209.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1125-2025·2025-02-19

    BD Pyxis MedStation 4000 Recalled for Drawer and Door Failures

    CareFusion 303, Inc. is recalling the BD Pyxis MedStation 4000 medication cabinet due to potential drawer and door failures that could delay access to stored medications.

    Product
    BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0559-2025·2025-02-19

    Marionberry Jelly Sticks Recalled for Undeclared Food Additives

    The Candy Basket Inc recalls Marionberry Jelly Sticks due to undeclared food additives and dyes. The product was sold in bulk in California, Oregon, and Washington.

    Product
    Marionberry Jelly Sticks MILK, item number CB745-M, is packed and sold in bulk 4lbs. boxes. Product does not have a UPC and is not repackaged for retail. Product was sold out of bulk chocolate cases from candy stores to consumers without any labeling. Label on bulk 4lbs. box d
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1123-2025·2025-02-19

    BD Pyxis MedStation Auxiliary ES medication cabinet drawer and door failures

    BD Pyxis MedStation Auxiliary ES medication cabinets are being recalled due to potential drawer and door failures following increased complaints. The failures could delay access to medications stored in the cabinet.

    Product
    BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0561-2025·2025-02-19

    Raspberry Jelly Sticks recalled for undeclared food dyes and preservatives

    The Candy Basket Inc is recalling Raspberry Jelly Sticks due to undeclared Red #40 and Potassium Sorbate. Products were distributed in California, Oregon, and Washington.

    Product
    Raspberry Jelly Sticks MILK, item number CB747-M, is packed and sold in bulk 4lbs. boxes. Product does not have a UPC and is not repackaged for retail. Product was sold out of bulk chocolate cases from candy stores to consumers without any labeling. Label on bulk 4lbs. box dec
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1120-2025·2025-02-19

    BD Pyxis Medication Dispensing Systems Recalled for Insufficient Labeling

    CareFusion is recalling six models of BD Pyxis medication management systems due to insufficient labeling regarding potential delays in medication access. The manufacturer is strengthening product labeling to address this risk.

    Product
    (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis MedStation 4000 Console, Catalog No. 309; (5) BD Pyxis MedStation 4000, Catalog No. 303; (6) BD Pyxis Anesthes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0562-2025·2025-02-19

    Raspberry Jelly Sticks Dark recalled for undeclared Red #40 and Potassium Sorbate

    The Candy Basket Inc is recalling Raspberry Jelly Sticks DARK for undeclared Red #40 and Potassium Sorbate. A total of 516 four-pound bulk boxes were distributed in California, Oregon, and Washington.

    Product
    Raspberry Jelly Sticks DARK, Item Number CB747-D, packed and sold in bulk 4lbs. boxes. Product does not have a UPC and is not repackaged for retail. Product was sold out of bulk chocolate cases from candy stores to consumers without any labeling. Label on bulk 4lbs. box declar
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1104-2025·2025-02-12

    Integra Miltex Cryosolutions Cartridges Recalled for Premature Valve Opening

    The Integra Miltex Cryosolutions Cartridges (Model C-CA-23) are being recalled because the valve may open prematurely during assembly, causing the cartridge to empty before use. Approximately 3,352 units were distributed nationwide in the US and Canada.

    Product
    Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0222-2025·2025-02-12

    Guaifenesin and Codeine Cough Syrup Recalled for Superpotent Strength

    PAI Pharmaceutical Associates is recalling Guaifenesin and Codeine Phosphate Oral Solution because the product contains higher-than-labeled active ingredient concentrations. The affected product was distributed in Ohio.

    Product
    GUAIFENESIN AND CODEINE PHOSPHATE — GUAIFENESIN AND CODEINE PHOSPHATE (GUAIFENESIN AND CODEINE PHOSPHATE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0214-2025·2025-02-12

    Timolol Maleate eye drops recalled for defective dropper cap

    FDC Limited is recalling Timolol Maleate ophthalmic solution because the dropper cap spike may become lodged in the bottle nozzle, preventing access to the medication. The recall affects one lot distributed to a single U.S. distributor in New Jersey.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1103-2025·2025-02-12

    Nitrous Oxide Cartridges Recalled Due to Premature Valve Opening

    Integra Miltex CryoSolutions N2O cartridges are recalled because the valve may open prematurely, causing partial or complete cartridge emptying before use. Affected units were distributed nationwide and to Canada.

    Product
    Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1112-2025·2025-02-12

    Beckman Coulter Access PCT Reagent Pack Recalled for Calibration Failures

    Beckman Coulter Inc. is recalling specific lots of Access PCT Reagent Pack due to high rates of calibration failures that delay test result reporting on immunoassay systems used in healthcare and laboratory settings.

    Product
    Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide