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.

2026–2050 of 3531

  • ModerateFDA (Devices)·Z-0235-2023·2022-11-23

    Atrium Ocean Wet Suction Chest Drains recalled due to storage temperature excursions

    Atrium Medical Corporation is recalling Atrium Ocean Wet Suction Water Seal Chest Drains (Product Code 2002-000) distributed in the United States due to warehouse temperature excursions in July and August 2021. No patient harm has been reported.

    Product
    Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0234-2023·2022-11-23

    GentleWave System Posterior Procedure Instrument Recall for Erroneous Carton Labels

    Sonendo Inc is recalling 16 GentleWave System Posterior CleanFlow procedure instruments with lot number W2022080204R due to erroneous unit carton labels that could affect proper identification and use.

    Product
    GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0157-2023·2022-11-23

    Similac 360 Total Care Infant Formula Recalled for Compromised Bottle Seals

    Abbott Laboratories is recalling batches of Similac 360 Total Care and Total Care Sensitive infant formula 2 fl oz discharge kits for compromised seal integrity that could allow spoilage. The affected batch is identified by product code 39480N200 with a Best By date of 04/01/23.

    Product
    Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as: 6 count kit
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0233-2023·2022-11-23

    GentleWave System APM Procedure Instruments recalled for erroneous carton labels

    Sonendo Inc is recalling 15 GentleWave System APM Procedure Instruments (Model GW-APM-PI02) due to erroneous unit carton labels. The instruments were distributed worldwide, including Ohio and Canada.

    Product
    GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0065-2023·2022-11-23

    Neostigmine Injection Recall for Potential Cross-Contamination Due to Manufacturing Controls

    Nephron Sterile Compounding Center is recalling 56,220 vials of PF-Neostigmine Methylsulfate Injection due to potential cross-contamination from manufacturing control deviations.

    Product
    PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0134-2023·2022-11-16

    Pomegranate Fruit Roll Ups recalled for higher sodium content than labeled

    Shemshad Food Products, Inc. is recalling Pomegranate Fruit Roll Ups due to sodium content measured at 131% of the declared level. The product was distributed to 8 retail locations in the Los Angeles area.

    Product
    2 oz. units of Pomegranate Fruit Roll Ups in boxes of 24, sold as individual units. Ingredients: Apple, Pomegranate, Water Sugar, Citric Acid, Salt. UPC: 0 84613 13066 8 Product of USA
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0196-2023·2022-11-16

    Alphatec Spine Disc Preparation Instruments Recalled for Regulatory Non-Compliance

    Alphatec Spine, Inc. is recalling 42 disc preparation surgical instruments due to manufacturing modifications that lacked proper regulatory clearance. The recall is limited to California.

    Product
    Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial Tip, 11A X 8P X 10 X 25mm, 15¿ TC11050 00840180510810 CI-11050-09102515 Longer IdentiTi PO Trial Tip, 12A X 9P X 10 X 25mm, 15¿ TC11050 00840180510827 CI-1105
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0192-2023·2022-11-16

    Cardinal Health Reusable Gel Pack Recalled for Unsafe Infant Use

    Cardinal Health Reusable Gel Packs are being recalled because they are unsafe for use on infants or neonates. The company will add a warning label stating the product is not for use on infants.

    Product
    Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0181-2023·2022-11-16

    Dialysis concentrate labeling error for chemical composition

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate (dialysis product) due to incorrect labeling. The label misidentifies 5.62g/L as potassium chloride when it actually represents calcium chloride, though the product itself is potassium-free.

    Product
    NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-0220-2023·2022-11-16

    Diagnostic Calibrator Kit Recalled for Software Defect Affecting System Calibration

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Calibrator Kit 9 due to incorrect calibration software (DRVs 6194-6200) that prevents laboratory systems from successfully calibrating, causing delayed test results.

    Product
    VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 . VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·23041·2022-11-10

    Hunter Fan Recalls Five Lighting Collections Due to Electric Shock Hazard

    Hunter Fan Company is recalling approximately 2,600 light fixtures from five collections because internal wires can become damaged, posing an electric shock hazard. Consumers should stop using the products immediately and contact Hunter for a full refund.

    Product
    Hunter branded Devon Park, Astwood, Highland Hill, Kerrison and Van Nuys light fixtures
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0025-2023·2022-11-09

    Ranibizumab eye implant recalled for non-functioning delivery system

    Genentech is recalling Susvimo ocular implants (452 units nationwide) due to manufacturing defects in the drug delivery system. A few patients have experienced non-functioning implants.

    Product
    SUSVIMO — SUSVIMO (RANIBIZUMAB)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0173-2023·2022-11-09

    BD Multitest 6-Color TBNK tubes recalled for partial label detachment

    BD Multitest 6-Color TBNK tubes are being recalled due to partial label detachment. The defect can cause tubes to stick together or lead to automation errors when used with the flow cytometer's automated loader.

    Product
    BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II, and BD FACSCanto flow cytometers to determine the percentages and absolute counts of human lymphocyte subsets in peripheral whole blood for immunophenotyping.
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-0129-2023·2022-11-02

    ConvaTec Active Life Stoma Pouch Recalled for Release Liner Malfunction

    ConvaTec is recalling 3,209 units of its Active Life One-Piece Drainable Pouch due to impaired functionality of the release liner. Contact the manufacturer with your batch number.

    Product
    ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a colostomy or ileostomy procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0079-2023·2022-11-02

    The Chai Box Chai Concentrate Recalled for Botulinum Contamination

    The Chai Box Chai Concentrate is being recalled due to potential Clostridium botulinum contamination identified during testing. Affected products have best-by dates from September 2022 to March 2023.

    Product
    THE CHAI BOX CHAI CONCENTRATE UNSWEETENED 16FL OZ/473ML glass bottles UPC 7 93611 81925 2 REGRIGERATE AFTER OPENING. USE WITHIN 14 DAYS and 64FL OZ/1892ML plastic bottles KEEP REFRIGERATED USE WITHIN 7 DAYS OF OPENING UPC 7 93611 81926 9. INGREDIENTS Water, Black Teas, Spices - C
    Category
    Food
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-0123-2023·2022-11-02

    Blood Culture Collection Kit Distributed with Mismatched Component Expiration Dates

    Medline is recalling 760 blood culture kits because the expiration dates printed on the kit do not match the expiration dates on the CHG Solution and Bactec bottle components inside.

    Product
    MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0121-2023·2022-11-02

    Medline Peripheral Blood Culture Draw Kit Recall: Incorrect Expiration Dates

    Medline is recalling 1,020 peripheral blood culture draw kits due to incorrect expiration dates on kit components. The CHG solution and Bactec bottle plastic have expiration dates that do not match the date listed on the kit.

    Product
    MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0126-2023·2022-11-02

    EMPOWER 3D Knee Tibial Insert Recall Due to Packaging Mix-Up

    Hip and knee implant boxes from Encore Medical may contain the wrong product, potentially causing surgery delays. The FDA is recalling affected units to prevent unavailability of correct implants.

    Product
    EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0135-2023·2022-11-02

    LumiraDx SARS-CoV-2 Quality Control Kit: Incorrect Lot Numbers

    LumiraDx is recalling 83 SARS-CoV-2 Antigen Liquid Quality Control Kits (batch 2002204017) with incorrect vial lot numbers. The kits contain Flu A/B lot numbers instead of SARS-CoV-2 Ag numbers, causing error messages and preventing device use.

    Product
    LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0120-2023·2022-11-02

    Medline Blood Culture Collection Kits Recalled for Incorrect Expiration Dates

    Medline recalls Adult Blood Culture Collection Kits due to incorrect expiration dates on kit components. The expiration dates on the CHG Solution and Bactec bottle plastic do not match the dates listed on the kit packaging.

    Product
    MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0012-2023·2022-10-26

    Rifampin Capsules recalled due to excess nitrosamine impurity

    Golden State Medical Supply Inc. is recalling Rifampin Capsules, 150 mg, due to elevated levels of 1-Methyl-4-Nitrosopiperazine (MNP) exceeding the FDA interim specification limit of 5 ppm. Affected lots are distributed nationwide.

    Product
    Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA, NDC 51407-322-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0056-2023·2022-10-26

    Lyons Ready Care Thickened Cranberry Honey Nectar Recalled for Product Spoilage

    Lyons Magnus LLC is recalling Lyons Ready Care Thickened Cranberry Honey Nectar due to indication of product spoilage. The recall involves 468 cases distributed across 49 states.

    Product
    Lyons Ready Care Thickened Cranberry Honey Nectar packaged in combi-bloc multi wall paper cartons 46 fl oz cartons - 6 cartons to a case
    Category
    Food
    Distribution
    48 states
  • ModerateFDA (Drugs)·D-0014-2023·2022-10-26

    OTC Sinus Pressure and Pain Cough Product Mislabeled as Decongestant-Free

    Walgreens Sinus Pressure, Pain & Cough tablets are mislabeled as 'Decongestant Free' but contain Phenylephrine HCl, a nasal decongestant. The labeling error affects 66,384 boxes distributed nationwide.

    Product
    SINUS PRESSURE, PAIN AND COUGH — SINUS PRESSURE, PAIN AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide