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.

3451–3475 of 3531

  • ModerateFDA (Devices)·Z-2085-2021·2021-07-28

    Liberty Drain Line Recalled for Freezing Temperature Exposure During Transport

    Fresenius Medical Care is recalling 6 cases of 026-20036A Liberty Drain Lines distributed in Texas due to exposure to freezing temperatures during refrigerated truck malfunction.

    Product
    026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2108-2021·2021-07-28

    Mindray battery cradle may prevent monitor from powering on

    Mindray is recalling the 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 and TM80 Telepack physiological monitors. The cradle may prevent the monitor from powering on. Approximately 804 units were distributed in the US and Canada.

    Product
    3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with physiological data monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0689-2021·2021-07-28

    Erythromycin Topical Solution 2% Recalled for Failed Impurities Specifications

    Teligent Pharma, Inc. is recalling Erythromycin Topical Solution USP 2% (60 mL, Lot 14180) distributed nationwide because it failed impurities and degradation specifications.

    Product
    Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2105-2021·2021-07-28

    Cell Marque Rabbit Monoclonal Antibody Distributed Without FDA Clearance

    Cell Marque recalled 41 kits of a rabbit monoclonal antibody product distributed for in-vitro diagnostic use without required FDA clearance. The product was distributed in 16 US states.

    Product
    Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-2067-2021·2021-07-21

    Medical device recall: Lingen SAMPLE Virus Sampling Kit lacks FDA clearance

    Mercedes Medical voluntarily recalled Lingen SAMPLE Virus Sampling Kits due to lack of FDA 510(k) clearance. The recall affects units distributed nationwide and internationally.

    Product
    Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·21169·2021-07-21

    Rite Aid Recalls Rechargeable Handheld Fans Due to Fire Hazard

    Rite Aid is recalling about 9,780 rechargeable handheld fans sold nationwide from April through June 2021 because the lithium ion battery can overheat while charging and pose a fire hazard. The company has received two reports of the fans overheating and emitting smoke, though no injuries have been reported.

    Product
    Rechargeable handheld fans
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0658-2021·2021-07-21

    Durisan Antimicrobial Hand Sanitizer Recalled for Manufacturing Deviations

    Sanit Technologies, LLC is recalling multiple lots of Durisan Antimicrobial Solutions hand sanitizer due to manufacturing deviations. The affected products were manufactured under the same conditions as contaminated lots.

    Product
    Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net Content 0.61 fl oz credit card size container, (UPC 8 52379 00614 1); b) 50 mL Net Content 1.69 oz bottle, (UPC 8 52379 00634 9 and 8 52379 0061
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0660-2021·2021-07-21

    Cipla Solifenacin Succinate Tablets Recalled for CGMP Deviations

    Cipla USA is recalling 7,228 bottles of Solifenacin Succinate Tablets, 10 mg (Lot #GG90819, expiring 06/2021) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna, Goa, India Manufactured for Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL, 33323, NDC 69097-261-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2059-2021·2021-07-21

    GE Healthcare MRI system button error causes incorrect diagnostic images

    GE Healthcare's SIGNA MR355 and MR360 MRI systems are recalled due to a button UI issue that may cause diagnostic images to be flipped or incorrectly annotated. No patient harm has been reported.

    Product
    SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0659-2021·2021-07-21

    Durisan Hand Sanitizing Wipes Recalled for CGMP Deviations

    Sanit Technologies, LLC is recalling Durisan Antimicrobial Solutions Hand Sanitizing Wipes (benzalkonium chloride, 0.13%) due to manufacturing deviations that could result in contaminated product.

    Product
    Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, packaged in 80-count canister (UPC 8 52379 00632 5), b) 160-count canister (UPC 8 52379 00631 8), and c) 240-count canister (UPC 8 52379 00633 2); Sanit Technologies, LLC, 7810 25th Court East,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2051-2021·2021-07-21

    Medical device recall: EASYGRIP FLO-41 barcode expiration date discrepancy

    Baxter Healthcare Corporation is recalling 4,752 units of EASYGRIP FLO-41 hemostatic delivery devices due to a discrepancy between the expiration date encoded in the 2D barcode and the human-readable date on the product.

    Product
    EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0652-2021·2021-07-21

    Nifedipine Extended-Release Tablets Recall for Failed Dissolution

    The Harvard Drug Group is recalling Nifedipine Extended-Release Tablets 30 mg due to failed dissolution specification discovered during routine stability testing. The affected lots were distributed in Ohio and New Jersey.

    Product
    NIFEDIPINE — NIFEDIPINE (NIFEDIPINE)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2066-2021·2021-07-21

    Medical Device Recall: Lingen Disposable Virus Sampling Kit, No 510(k) Clearance

    The Lingen Disposable Virus Sampling Kit by Mercedes Medical was voluntarily recalled due to lacking FDA 510(k) clearance. The recall affected approximately 11,711 boxes distributed nationwide and internationally.

    Product
    Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0653-2021·2021-07-21

    Homeopathic supplement B Force recalled for being superpotent

    B Force, a homeopathic oral supplement containing multiple active ingredients, is being recalled because it is superpotent. The product was distributed in Florida.

    Product
    B FORCE — B FORCE (ECHINACEA ANGUSTIFOLIA, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, LYMPH NODE (SUIS), SPLEEN (SUIS), THYMUS (SUIS), THYROIDINUM (SUIS), ARSENICUM ALBUM, BELLADONNA, HYPERICUM PERFORATUM, PHOSPHORUS, BOTULINUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS), PSEUDOMONAS AERUGINOSA, PROTEUS (MORGANI), SALMONELLA TYPHI NOSODE, CLOSTRIDIUM PERFRINGENS)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2069-2021·2021-07-21

    Arrow Temporary Pacing Catheter Kit Recalled for Marketing Without FDA 510K Clearance

    Arrow International is recalling its Temporary Pacing Catheter/Introducer Kit (5 units) because it was marketed without FDA 510K clearance. Affected lot numbers: 16F20C0035 and 16F20F0124.

    Product
    Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2060-2021·2021-07-21

    SIGNA MR380 MRI System Patient Orientation Button May Click Unintentionally

    GE Healthcare is recalling the SIGNA MR380 MRI system due to a user interface flaw where the Patient Orientation button may be inadvertently clicked instead of the Save RX button. This can result in incorrectly annotated or flipped MRI images.

    Product
    SIGNA MR380, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateCPSC·21763·2021-07-15

    Real Flame Arroyo and Hideaway Wood Burning Fire Pits Recalled for Fire Hazard

    Real Flame is recalling approximately 700 Arroyo and Hideaway wood burning fire pits sold at Crate and Barrel because wood stored under the units can ignite, posing a fire hazard. One incident with minor property damage has been reported.

    Product
    Arroyo and Hideaway Wood Burning Fire Pits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2021-2021·2021-07-14

    GE Revolution CT User Interface Issue with Scan Groups

    The GE Revolution CT user interface may fail to confirm when scan group names are added if they contain characters other than letters, numbers, or spaces.

    Product
    The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs inclu
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0771-2021·2021-07-14

    Yakult Nonfat Probiotic Drink recalled for Candida pelliculosa

    Yakult U.S.A. Inc. is recalling Yakult Nonfat Probiotic Drink (2.7 FL. OZ. bottles) because testing found trace levels of yeast and the presence of Candida pelliculosa in the product.

    Product
    Yakult Nonfat Probiotic Drink; Live and active Lactobacillus casei Shitota; 2.7 FL. OZ. (80 mL), 5 individual bottles per pack, 10 packs per case. Bottle UPC: 4520 8812 5 pack UPC: 6 99235 00100 7 Ingredients: Water, Sugar, Nonfat Milk, Glucose, Natural Flavors, Lactobacillus
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2031-2021·2021-07-14

    Sterile Femoral Angiography Drape Sticks; Cannot Unfold Properly

    Cardinal Health is recalling 574 units of Sterile Femoral Angiography Drapes because the plastic film causes the drapes to stick, preventing proper unfolding and application during surgery.

    Product
    Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2012-2021·2021-07-14

    ACE Control Set stability claim failure requires updated handling instructions

    Sentinel CH SpA is recalling ACE Control Set diagnostic control kits due to stability claims after reconstitution that do not meet specified requirements. Updated handling instructions have been provided to affected users.

    Product
    ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0786-2021·2021-07-14

    Hatch Verde Salsa Recalled for Potential Foreign Material

    Heritage Family Specialty Foods, Inc. is recalling Hatch Verde Salsa Medium (12 oz jars) due to potential foreign material contamination. The recall affects 646 cases distributed nationwide.

    Product
    Hatch Verde Salsa Medium Net Wt. 12 oz (340g) 6 jars per case packaged in clamshell container UPC Code: 810041591999
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateCPSC·21164·2021-07-14

    Walgreens Recalls Disney Baby Winnie the Pooh Rattle Sets for Choking Hazard

    Walgreens is recalling about 54,000 Disney Baby Winnie the Pooh Rattle Sets because the feet can detach and pose a choking hazard to young children. Consumers should immediately remove the rattle from children and contact Walgreens for a refund.

    Product
    Disney Baby Winnie the Pooh Rattle Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2022-2021·2021-07-14

    GE Healthcare Revolution CT user interface fails to confirm scan group addition

    The GE Healthcare Revolution CT system's user interface fails to update and confirm when scan group names are added using certain characters. This configuration defect requires a software fix to ensure proper scan group setup.

    Product
    The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs includ
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2023-2021·2021-07-14

    GE Revolution CT scanner user interface fails to confirm scan group names

    The GE Revolution CT imaging system's user interface fails to update and confirm when scan group names contain characters other than letters, numbers, or spaces, potentially causing user uncertainty during scan setup.

    Product
    The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either witho
    Category
    Medical Device
    Distribution
    0 states