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.

3101–3125 of 3531

  • ModerateFDA (Devices)·Z-0304-2022·2021-12-01

    Siemens Artis Q.zen Angiography System X-ray Activation Failure

    Siemens is recalling 15 Artis Q.zen angiography systems that may fail to generate x-rays when the lift mechanism and x-ray release are activated simultaneously, potentially causing a procedural delay.

    Product
    Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0300-2022·2021-12-01

    Siemens Artis Q floor angiography system: X-ray failure during SID lift operation

    Siemens Artis Q floor angiography systems may fail to produce x-ray when SID lift movement is activated during x-ray release, resulting in procedural delays. The system displays an error message.

    Product
    Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848280
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0240-2022·2021-12-01

    Medical X-Ray Systems Missing Required Radiation Warning Labels

    Philips Healthcare is recalling ProxiDiagnost N90 diagnostic X-ray systems that lack required FDA radiation warning labels. Some units nationwide were found missing the mandatory radiation safety labels and certification statements required by federal standards.

    Product
    ProxiDiagnost N90 is multi-functional general R/F systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0259-2022·2021-12-01

    Diclofenac Sodium Topical Solution recalled for defective container

    Teligent Pharma, Inc. is recalling Diclofenac Sodium Topical Solution USP 1.5% due to a defective container. The recall affects 5,400 units distributed nationwide.

    Product
    Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 70512-025-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0296-2022·2021-12-01

    Medical Imaging System May Fail to Release X-rays Under Specific Conditions

    Siemens Artis zee floor angiography systems may fail to release x-rays when the SID lift and x-ray functions are activated simultaneously, causing procedural delay. Three units are affected.

    Product
    Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0305-2022·2021-12-01

    Siemens Artis Q.zen Angiography System X-Ray Imaging Delay Issue

    Siemens has recalled two Artis Q.zen angiography systems due to a software issue that may prevent x-ray imaging and delay procedures when SID lift and x-ray controls are activated simultaneously.

    Product
    Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10848355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0302-2022·2021-12-01

    Siemens Artis Q Biplane X-ray System Software Imaging Delay Issue

    Siemens Medical Solutions is recalling 15 Artis Q biplane diagnostic x-ray systems due to a software issue in the VD12-angiography subsystem. When source-to-image distance lift is activated simultaneously with x-ray release, the system fails to activate and displays an error message, causing procedural delay.

    Product
    Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848282
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0258-2022·2021-12-01

    Diclofenac Sodium Topical Solution recalled for defective container

    Teligent Pharma, Inc. is recalling Diclofenac Sodium Topical Solution USP 1.5% w/w due to a defective container. The recall affects approximately 2,664 bottles distributed nationwide.

    Product
    Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 52565-002-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0254-2022·2021-11-24

    Lotrimin Daily Prevention Deo Tolnaftate Spray Recalled for Potential Benzene Contamination

    Bayer Healthcare Pharmaceuticals is recalling Lotrimin AF Daily Prevention deodorant powder spray due to cGMP deviations at the manufacturing facility where other lots were found contaminated with benzene.

    Product
    LOTRIMIN DAILY PREVENTION DEO — LOTRIMIN DAILY PREVENTION DEO (TOLNAFTATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0232-2022·2021-11-24

    Cartia XT Diltiazem Hydrochloride Capsules Recalled for Incorrect Expiration Date

    Teva Pharmaceuticals USA is recalling Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg due to an incorrect expiration date printed on the label. The affected lot was distributed nationwide.

    Product
    CARTIA — CARTIA (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0249-2022·2021-11-24

    Vitrification Freeze Kit Recalled Due to Incorrect Expiration Date Labeling

    Fujifilm Irvine Scientific is recalling Vit Kit-Freeze due to incorrect expiration date labeling on a component. The incorrect label could lead to use of degraded solutions in assisted reproductive procedures.

    Product
    Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0235-2022·2021-11-24

    Clonidine Transdermal System patches recalled for impurities and degradation

    Teva Pharmaceuticals USA is recalling 64,978 Clonidine Transdermal System patches (0.1 mg/day) due to failed specifications for impurities and degradation. The recall affects nationwide and Puerto Rico distribution.

    Product
    CLONIDINE TRANSDERMAL SYSTEM — CLONIDINE TRANSDERMAL SYSTEM (CLONIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0248-2022·2021-11-24

    Reproductive Medical Device Recalled for Incorrect Expiration Date Labeling

    Fujifilm Irvine Scientific is recalling Vit Kit-Freeze, a medical device used in assisted reproductive procedures, due to kit components being labeled with incorrect expiration dates.

    Product
    Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0256-2022·2021-11-24

    REGARD Vitrectomy Tray Recalled for Out-of-Specification Antiseptic Component

    ROi CPS LLC is recalling 22 REGARD Vitrectomy Trays because the povidone-iodine swab component was manufactured out of specifications. Distribution was limited to Florida, Louisiana, and Missouri.

    Product
    REGARD Vitrectomy Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0234-2022·2021-11-24

    Flocinolone Acetonide 0.01% Topical Oil Recalled for Subpotent Drug

    Amneal Pharmaceuticals is recalling Flocinolone Acetonide 0.01% Topical Oil because testing found out-of-specification assay results, meaning the drug may contain less active ingredient than labeled.

    Product
    Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-703-86
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0211-2022·2021-11-24

    Chopped Romaine Lettuce Recalled for Plastic Contamination

    Church Brothers, LLC is recalling True Leaf VA Romaine Chopped lettuce due to plastic pieces found in the product. The affected lot was distributed in Maryland.

    Product
    True Leaf VA - Romaine Chopped, 6x2 lb. True Leaf Product of USA
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0263-2022·2021-11-24

    FDA Class II Quantum 2000 Electrosurgical Generators Voluntary Recall

    CooperSurgical is voluntarily recalling 154 Quantum 2000 Electrosurgical Generators under FDA Class II classification. The specific reason for recall is not documented in available source information.

    Product
    Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0233-2022·2021-11-24

    Flocinolone Acetonide 0.01% Topical Oil Recalled for Subpotency

    Amneal Pharmaceuticals is recalling Flocinolone Acetonide 0.01% Topical Oil due to an out-of-specification assay result indicating the drug is subpotent and may not deliver the intended therapeutic dose.

    Product
    Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-704-86
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateCPSC·22022·2021-11-23

    Impex Fitness Olympic Dumbbell Handles Recalled for Impact Injury Hazard

    Impex Fitness is recalling about 77,200 Olympic Dumbbell Handles because the locking collars can slip, causing weights to drop and potentially cause impact injuries. No injuries have been reported to date.

    Product
    Olympic Dumbbell Handles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·22711·2021-11-18

    AmazonBasics Memory Foam Mattresses Recalled for Fire Hazard

    Amazon is recalling about 15,300 AmazonBasics Memory Foam Mattresses sold between April 2020 and March 2021 because they fail to meet federal flammability standards, posing a fire hazard. No injuries have been reported.

    Product
    AmazonBasics Memory Foam Mattresses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0095-2022·2021-11-17

    Acetaminophen Oral Suspension Recalled Due to Contaminated Raw Ingredient

    Precision Dose Inc. is recalling Acetaminophen Oral Suspension (325 mg/10.15 mL) due to contaminated raw ingredient used in manufacturing. The recall affects 151,100 unit dose cups distributed nationwide for hospital use.

    Product
    ACETAMINOPHEN — ACETAMINOPHEN (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0138-2022·2021-11-17

    Country Oven Chocolate Cake recalled for possible metal fragments

    The Kroger Co is recalling Country Oven Chocolate Cake in multiple package sizes due to possible metal fragments in the starch used to manufacture the product.

    Product
    Country Oven Chocolate Cake 13.5oz, 60oz, 40oz
    Category
    Food
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0214-2022·2021-11-17

    T4 EIA Diagnostic Kit Recall Due to Shelf-Life Quality Standards Failure

    BioCheck, Inc. is recalling 314 T4 EIA Kit units due to failed shelf-life standards that resulted in failed quality control tests. The kits were distributed to five U.S. states and three overseas countries.

    Product
    T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.
    Category
    Medical Device
    Distribution
    5 states