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.

6351–6375 of 21595

  • ModerateFDA (Devices)·Z-0105-2021·2020-10-21

    Cook Inc. Recalls Percutaneous Neonatal Pigtail Nephrostomy Sets

    Cook Inc. is recalling 368 Percutaneous Neonatal Pigtail Nephrostomy Sets because the indwell time is decreasing from 4 months to 4 weeks.

    Product
    Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22 gage, 5 cm Chiba Needle; an 18 gage, 5 cm trocar needle; an .038-inch (.97 mm) diameter, 30 cm PTFE-coated stainless steel; a 5, 6, and 7 French, 10 cm radiopa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0034-2021·2020-10-21

    Leadiant Recalls Subpotent Cystaran Ophthalmic Solution

    Leadiant Biosciences is recalling 1,380 bottles of Cystaran ophthalmic solution because testing found decreased levels of the active ingredient.

    Product
    CYSTARAN — CYSTARAN (CYSTEAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0098-2021·2020-10-21

    Smart Care Hand Sanitizer Recall Due to Misleading Packaging Resembling Food and Drink

    The FDA is recalling Smart Care hand sanitizers because their container packaging is designed to look like food and drink pouches, potentially confusing consumers.

    Product
    Smart Care HAND SANITIZER, Ethyl Alcohol 62%, packaged in 0.84 FL.OZ (25 mL), labeled as a) Paw Patrol (Item #: 92321-144, UPC 8 50016 92321 9, NDC 70108-042-01); b) JoJo Siwa Dreamer (Item #: 92320-144, UPC 8 50016 92320 2, NDC 70108-044-01); c) Hot Wheels (Item #: 92317-144,
    Category
    Consumer Product
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0106-2021·2020-10-21

    Cook Inc. Recalls Pediatric Nephrostomy Stent Sets Due to Labeling Update

    Cook Inc. is recalling 380 Pediatric Nephrostomy Stent Sets because the indwell time is decreasing from 4 months to 4 weeks. The Instructions for Use are being updated to reflect this change.

    Product
    Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail catheter and stent, retention disc with pull tie, and a 10 French, 30 cm polyvinylchloride connecting tube with one-way stopcoc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0092-2021·2020-10-21

    Getinge Servo-i Ventilator Recall for Short Nebulizer Connector

    Getinge is recalling 431 Servo-i Ventilators because a nebulizer connector may be shorter than specified, potentially preventing the Aeroneb Nebulizer module from installing successfully.

    Product
    Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It supports a variety of breathing modes and can be used for N
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0093-2021·2020-10-21

    Biomet Shoulder Prosthesis Baseplate Packaging Error Recall

    Biomet is recalling 3 units of Comprehensive Reverse Shoulder Glenosphere Mini Baseplates due to packaging errors where components may be missing or duplicated.

    Product
    Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0107-2021·2020-10-21

    Ezycare Disposable Face Masks Recalled for Mislabeling as Non-Medical

    FDA is recalling Ezycare disposable face masks because they were labeled as non-medical but distributed to customers expecting medical use.

    Product
    Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0014-2021·2020-10-21

    J.R. Simplot Recalls Trader Joe's Potato Tots for Foreign Material

    J.R. Simplot is recalling Trader Joe's Trader Potato Tots due to the potential presence of small pieces of plastic or rubber material.

    Product
    TRADER JOE S TRADER POTATO TOTS is frozen potatoes, SKU # 94904, retail bag has net wt. 2 lbs. Product is packaged in plastic bag. TRADER JOE S TRADER POTATO TOTS, master case is labeled as 0094 9040, frozen potatoes. There are 18/2 lbs. bags per case. The retail label is
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0011-2021·2020-10-14

    Calvin Scott Recalls Phentermine Capsules Due to Stability Study Deviations

    Calvin Scott & Company is recalling specific lots of Phentermine 30 mg capsules because they were repackaged without supporting stability studies.

    Product
    Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-0597-10
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0077-2021·2020-10-14

    Biomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment

    Biomet 3i is recalling 35 units of BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.

    Product
    CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Food)·F-0011-2021·2020-10-14

    Nettle Meadow Artisan Cheese Recalled Due to Pasteurization Recording Failure

    LuMaZu, LLC dba Nettle Meadow is recalling artisan cheese because pasteurization temperatures were not recorded for two lots due to a recorder malfunction.

    Product
    "Nettle Meadow Artisan Cheese *** Roasted Red Pepper Fromage Frais***Contains pasteurized goat and cows milk***5 oz."
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0052-2021·2020-10-14

    Siemens Troponin I Reagent Cartridge Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling Dimension LOCI High Sensitivity Troponin I reagent cartridges due to positive bias in test results.

    Product
    Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0056-2021·2020-10-14

    Brainlab Ultrasound Navigation Software Recalled for Image Width Limitation

    Brainlab AG is recalling Ultrasound Navigation Software 1.0 and related integration software because the system does not support modifying the probe's image width.

    Product
    Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0075-2021·2020-10-14

    Biomet 3i Recalls Misaligned BellaTek Dental Abutments

    Biomet 3i is recalling 9 units of BellaTek Encode Definitive Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.

    Product
    CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Drugs)·D-0010-2021·2020-10-14

    Calvin Scott Recalls Diethylpropion Tablets Due to Missing Stability Studies

    Calvin Scott & Company is recalling specific lots of Diethylpropion 75 mg tablets because they were repackaged without supporting stability studies.

    Product
    Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1477-01
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Food)·F-0012-2021·2020-10-14

    Nettle Meadow Truffle Fromage Frais Recalled Due to Pasteurization Record Failure

    LuMaZu, LLC dba Nettle Meadow is recalling 16 units of Truffle Fromage Frais because pasteurization temperatures were not recorded for two lots due to a recorder malfunction.

    Product
    "Nettle Meadow Artisan Cheese *** Truffle Fromage Frais***Contains pasteurized goat and cows milk*** 5 oz."
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0009-2021·2020-10-14

    Calvin Scott Recalls Diethylpropion Tablets Due to Stability Deviations

    Calvin Scott & Company is recalling specific lots of Diethylpropion 25 mg tablets because they were repackaged without supporting stability studies.

    Product
    Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1475-01
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Food)·F-0009-2021·2020-10-14

    Nettle Meadow Fig Honey Fromage Frais Recalled for Pasteurization Record Failure

    LuMaZu, LLC dba Nettle Meadow is recalling Fig Honey Fromage Frais because pasteurization temperatures were not recorded for two lots due to a recorder malfunction.

    Product
    "Nettle Meadow Artisan Cheese *** Fig Honey Fromage Frais*** Contains pasteurized goat and cows milk*** 5 oz.***"
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0013-2021·2020-10-14

    Nettle Meadow Artisan Cheese Recalled Due to Unrecorded Pasteurization Temperature

    LuMaZu, LLC dba Nettle Meadow is recalling two cases of Habanero Peach Fromage Frais because pasteurization temperatures were not recorded due to a recorder malfunction.

    Product
    "Nettle Meadow Artisan Cheese *** Habanero Peach Fromage Frais***Contains pasteurized goat and cows milk*** 5 oz."
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0057-2021·2020-10-14

    Zimmer Biomet Recalls Dual Mobility Vivacit-E Bearing Due to Sizing Error

    Zimmer Biomet is recalling 31 Dual Mobility Vivacit-E bearings because the outer package label indicates a different size than the implant inside.

    Product
    Dual Mobility Vivacit-E Bearing, Model Number 110031009
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-0053-2021·2020-10-14

    Ultradent PermaFlo Flowable Composite Recalled for Manufacturing Cross-Contamination

    Ultradent Products, Inc. is recalling PermaFlo Flowable Composite due to a potential manufacturing issue causing cross-contamination and non-homogeneity.

    Product
    PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0030-2021·2020-10-14

    Skippy Super Chunk Peanut Butter Recalled for Aflatoxin Levels

    Hormel Foods is recalling Skippy Super Chunk Peanut Butter because aflatoxin levels were slightly above the actionable limit.

    Product
    SKIPPY Super Chunk Peanut Butter 16.3oz UPC: 00037600110723 packaged in non-flexible plastic container
    Category
    Food
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-0074-2021·2020-10-14

    Biomet 3i Recalls Misaligned BellaTek Titanium Abutments

    Biomet 3i is recalling BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement in patients.

    Product
    BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0071-2021·2020-10-14

    Skytron VGA to Fiber Converter Recall for Video Signal Failure

    Skytron is recalling 11 VGA to Fiber Converter units for the SkyVision Linx 300 system due to faceplate failures that cause video signal loss on secondary displays.

    Product
    VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System Model: VGDF-SKY (version 2). For communication and visual image management in the operating room suite.
    Category
    Medical Device
    Distribution
    5 states