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.

3376–3400 of 3531

  • ModerateFDA (Devices)·Z-2408-2021·2021-09-08

    FaStep COVID-19 Test Devices Recalled for Unauthorized Laboratory Distribution

    Versea Diagnostics recalled 563,290 FaStep COVID-19 antibody test devices that were distributed to laboratories not certified under federal standards. The devices were authorized only for use in CLIA-certified laboratories.

    Product
    FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. Intended for use as an aid in identifying individuals w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2359-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit Withdrawn for Labeling and Instructions Enhancement

    Covidien voluntarily withdrew Palindrome RT Chronic Catheter Kit worldwide to implement improved point-of-use labeling and enhanced instructions for use on each device.

    Product
    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2366-2021·2021-09-08

    Palindrome RT Repair Kit Withdrawn for Enhanced Labeling and Instructions

    Covidien is voluntarily withdrawing the Palindrome RT Repair Kit 15 FR TAL 28cm to improve point-of-use labeling and Instructions for Use. No illnesses or injuries have been reported.

    Product
    Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2361-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit Labeling Enhancement Withdrawal

    Covidien, LP is voluntarily withdrawing Palindrome RT Chronic Catheter Kits to implement improved point-of-use labeling and Instructions for Use. No injuries or illnesses have been reported.

    Product
    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0928-2021·2021-09-08

    Flourless Chocolate Torte mislabeled with wrong product and allergen information

    Gem City Fine Foods is recalling Flourless Chocolate Torte because the product is mislabeled with Triple Berry Streusel Cheesecake ingredients and nutrition information, and both products are labeled to contain pecans despite no nuts being used.

    Product
    Flourless Chocolate Torte, 14 oz., in recyclable plastic circular container with black base and clear lid, Gem City Fine Foods, 3403 S 1400 W, Suite C, West Valley City, UT 84119. There are 4/cs. UPC 855026001186. Store Frozen or Thawed in Fridge.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2336-2021·2021-09-01

    KeyPrint Soft Dental Resin Recalled for Incorrect European Labeling

    Straumann USA LLC recalled KeyPrint Soft resin bottles (Lot KJ2858) that were distributed with European product labels instead of US-compliant labeling. Dental professionals should verify if they received affected units.

    Product
    KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·21192·2021-09-01

    PetSmart Recalls Top Paw Double Diner Dog Bowls for Laceration Hazard

    PetSmart is recalling about 100,300 Top Paw Double Diner Dog Bowls because the gasket on the bottom can come off, leaving a sharp unfinished edge that poses a risk of laceration. Three reports of cuts and scratches have been received.

    Product
    Top Paw® Double Diner Dog Bowls
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2334-2021·2021-09-01

    FDA Recalls Reprocessed IVUS Catheters Due to Reprocessing Cycle Violation

    Northeast Scientific Inc. is recalling 690 reprocessed intravascular ultrasound catheters because they exceed the FDA-approved single reprocessing cycle limit. Devices were distributed nationwide across ten states.

    Product
    NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. NES Ref. No. R-88901
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0762-2021·2021-09-01

    PDI Povidone-Iodine Cleansing Scrub Swabstick Recalled for Subpotency

    Professional Disposables International is recalling PDI Povidone-Iodine Cleansing Scrub Swabsticks distributed nationwide because the product is subpotent—meaning it contains less active ingredient than specified.

    Product
    PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S48050, NDC 10819-3891-2, UPC (01)00310819000192.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0757-2021·2021-09-01

    Micafungin for Injection recalled for incomplete package insert

    Xellia Pharmaceuticals is recalling Micafungin for Injection due to an incomplete package insert that omits required sections on adverse reactions, drug interactions, and use in specific populations.

    Product
    Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-037-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0760-2021·2021-09-01

    PVP Iodine Prep Pads Recalled for Potency Below Specification

    Professional Disposables International is recalling PVP Iodine Prep Pads distributed nationwide because the product is subpotent—meaning the active ingredient strength falls below FDA specifications. Affected lots were distributed across the United States.

    Product
    PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0763-2021·2021-09-01

    PDI Povidone-Iodide Cleansing Scrub Swabstick Recall for Subpotency

    Professional Disposables International is recalling PDI Povidone-Iodide Cleansing Scrub Swabsticks distributed nationwide because the product is subpotent—meaning the active ingredient strength is below the required specification.

    Product
    PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376, Reorder No S82125, NDC 10819-3891-3, UPC (01)00310819000208.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0759-2021·2021-09-01

    PDI Povidone-Iodine Prep Pads Recalled for Subpotent Active Ingredient

    Professional Disposables International is recalling PDI Povidone-Iodine Prep Pads distributed nationwide because the product is subpotent—the active ingredient falls below specification. Consumers should stop using affected lots and consult their healthcare provider.

    Product
    PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0761-2021·2021-09-01

    PDI Povidone-Iodine Swabstick Prep Pads Recalled for Subpotency

    Professional Disposables International is recalling PDI Povidone-Iodine Swabsticks nationwide because the product is subpotent—meaning the active ingredient is below the required specification.

    Product
    PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2333-2021·2021-09-01

    BD Mouse IgG2a Antibody Reagent Recalled for Manufacturing Contamination

    This antibody reagent was recalled due to manufacturing contamination that may produce false positive staining results in laboratory tests. The affected lot was distributed worldwide.

    Product
    BD" Mouse IgG2a Isotype Control APC X39 ASR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0756-2021·2021-09-01

    Micafungin for Injection Recalled for Incomplete Package Insert

    Xellia Pharmaceuticals USA is recalling Micafungin for Injection 50 mg/vial due to an incomplete package insert that omits required sections on Adverse Reactions, Drug Interactions, and Use in Specific Populations.

    Product
    Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-036-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0764-2021·2021-09-01

    PDI Duo-Swab Povidone-Iodine Cleansing Swabstick Recalled for Subpotency

    Professional Disposables International is recalling PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabsticks due to subpotency—the active ingredient is below the specified strength, which may reduce effectiveness for skin antisepsis.

    Product
    PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S23125, UPC (01)0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0758-2021·2021-09-01

    PVP Iodine Prep Pads Recalled for Subpotent Active Ingredient

    Professional Disposables International is recalling PVP Iodine Prep Pads nationwide because the products are subpotent—containing less active ingredient than specified. The affected prep pads may not provide adequate antiseptic protection.

    Product
    PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0769-2021·2021-09-01

    Erythromycin Topical Solution Recalled for Defective Container Seal

    Teligent Pharma, Inc. is recalling Erythromycin Topical Solution USP 2% (60 mL bottles) due to defective containers that may lack seal integrity, potentially allowing contamination or leakage.

    Product
    Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0766-2021·2021-09-01

    Sodium Phenylbutyrate Powder Recalled for Failed Impurities Specifications

    SigmaPharm Laboratories is recalling Sodium Phenylbutyrate powder nationwide due to out-of-specification impurity results found during routine testing. Affected bottles have specific lot numbers and expiration dates ranging from May 2023 to May 2024.

    Product
    SODIUM PHENYLBUTYRATE — SODIUM PHENYLBUTYRATE (SODIUM PHENYLBUTYRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2339-2021·2021-09-01

    OASIS MRI table pads recalled for missing latex allergen labeling

    Hitachi Healthcare Americas has recalled OASIS MRI System table pads due to missing labels and user manual notification about dry natural rubber content. The missing notification violates federal labeling requirements for this latex allergen.

    Product
    OASIS MRI System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·21777·2021-08-26

    Ryan and Rose Cutie Spoovel Children's Eating Utensils Choking Hazard Recall

    Ryan and Rose is recalling Cutie Spoovel children's eating utensils because the handle can break off when bitten, releasing small parts that pose a choking hazard to young children. No injuries or choking incidents have been reported.

    Product
    Cutie Spoovel children's eating utensils
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0920-2021·2021-08-25

    Holle Goat Stage 2 Infant Formula Recalled for Missing FDA Pre-Market Notification

    Able Groupe Inc is recalling Holle Goat Stage 2 Organic Follow-On Infant Milk Formula (76,000 units) because required pre-market notifications were not submitted to the FDA and products lack mandatory labeling in English.

    Product
    Holle Goat Stage 2 Organic Follow-On Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • ModerateCPSC·21188·2021-08-25

    Wee Gallery wooden tray puzzles recalled for choking hazard

    Wee Gallery is recalling Ocean and Safari animal wooden tray puzzles because the octopus and elephant puzzle pieces can break, posing a choking hazard to young children.

    Product
    Ocean and Safari animal wooden tray puzzles
    Category
    Consumer Product
    Distribution
    Distributed nationwide