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.

651–675 of 3531

  • ModerateFDA (Devices)·Z-2697-2024·2024-08-28

    Medline Medical Soft Liner Recall Due to Dimensional Variation

    Medline Industries recalls 1.5L medical soft liners due to slight dimensional variations that may cause difficulty fitting into the outer canister. The recall affects 88,703 units distributed worldwide.

    Product
    1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2694-2024·2024-08-28

    Medline Soft Suction Canister Liner Recalled for Dimensional Variation

    Medline Industries recalls soft suction canister liners due to dimensional variation that may cause difficulty fitting the product into the outer canister. The issue affects units distributed worldwide.

    Product
    LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2699-2024·2024-08-28

    Medical Device Liner Recalled for Dimensional Variation Affecting Fit

    Medline Industries has recalled 316,125 units of its MED-SOFT Single Liner with Solidifier due to a dimensional variation that may cause difficulty when inserting the product into the outer canister.

    Product
    1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2709-2024·2024-08-28

    Medline medical procedure kits recalled due to dimensional variation

    Medline Industries is recalling 1,700 medical procedure kits due to a dimensional variation that may cause fitting difficulty into the outer canister. The affected kits were distributed in the US and internationally.

    Product
    Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM2169
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2700-2024·2024-08-28

    Medline Anesthesia Circuit Kits Recalled for Dimensional Variation

    Medline is recalling three models of anesthesia circuit kits due to slight dimensional variations that may cause difficulty fitting into the outer canister. The recall affects 1920 units distributed worldwide.

    Product
    Medline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT ADULT, REF DYNJAAF6666B; b) ANESTHESIA CIRCUIT PEDS-LF, REF DYNJAP9918A; c) CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0640-2024·2024-08-28

    HAND-I-SAN Hand Sanitizer Recalled for Manufacturing Process Deviation

    HAND-I-SAN No-Rinse Hand Sanitizer is being recalled due to manufacturing process deviations involving the use of non-sterile water in production. The product was distributed nationwide and to Canada.

    Product
    HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4x1 gallon jugs), b) 18.92L (5-gallon pail), c) 208.19L (55-gallon drum), and d) 1040.98L (275-gallon tote), ZEE Company 3401 Cummings Road, Chattanooga, TN, 374
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2708-2024·2024-08-28

    Medline Medical Procedure Kits Recalled for Dimensional Variation in Canister Fitting

    Medline Industries is recalling 75,098 medical procedure kits due to slight dimensional variations that may cause difficulty fitting into their outer canisters. No injuries or illnesses have been reported.

    Product
    Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN KIT, REF DYKM1184; c) DENTAL CDS, REF CDS984010B; d) EGD KIT, REF DYK1253578F; e) EGD REG KIT, REF DYKE1830; f) ENDO KIT, REF DYKE1516A; g) ERCP REG KIT, REF DYKM2127; h) GI P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2639-2024·2024-08-28

    C-Flow Bag Decanter Packaging Defects Prompt Sterile Barrier Recall

    Microtek Medical Inc. recalls C-Flow Bag Decanters (10,366 cases) due to pin holes and tears in sterile barrier packaging discovered during quality testing. The defects could allow bacterial contamination.

    Product
    C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2691-2024·2024-08-28

    Clinical Chemistry Analyzer Software Issue Causes Delayed Results

    Beckman Coulter clinical chemistry analyzers have a software issue that delays diagnostic results after processing 250 racks. Affected units experience buffer errors and result delays.

    Product
    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2717-2024·2024-08-28

    Covidien McGRATH MAC Video Laryngoscope Instruction Update for Battery Handling

    Covidien is recalling the McGRATH MAC Video Laryngoscope to address battery handling information in its instructions. The recall affects devices distributed worldwide.

    Product
    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2714-2024·2024-08-28

    Medline Surgical Procedure Kits Recalled for Dimensional Fit Issue

    Medline is recalling 14,977 surgical procedure kits due to dimensional variations that may cause difficulty fitting into the outer canister.

    Product
    Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYNJ909699; b) BACK CDS, REF CDS984000C; c) EXTREMITY, REF DYNJ900847A; d) HAND-LF, REF DYNJ902619G; e) HIP PINNING CDS, REF CDS984009C; f) HIP PINNING/TFN/ANTERIOR HIP, REF DYNJ902380K; g) KNEE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2707-2024·2024-08-28

    Medline Medical Procedure Kits Recalled for Dimensional Variation

    Medline Industries recalled 3,539 medical procedure kits due to a dimensional variation that may prevent proper fitting into their outer storage canister. The FDA classified this as a Class II recall.

    Product
    Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b) MINOR BREAST, REF DYNJ905002B; c) SUCTION MEDI VAC, REF DYKM2033
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2687-2024·2024-08-28

    Dental Digital Analog Products Recalled for Out-of-Specification Rotation

    Preat Corp is recalling 185 dental digital analog products due to out-of-specification rotation affecting inspection accuracy. The devices are used in dental laboratories for visual inspection of abutments and restorations.

    Product
    Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303 3i Certain-compatible 5.0mm Digital Analog, REF 9001903 3i Certain-compatible 6.0mm Digital Analog,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2713-2024·2024-08-28

    Medline Medical Procedure Kits Recalled for Dimensional Variation Affecting Outer Canister Fit

    Medline Industries is recalling certain C-Section surgical kits due to dimensional variations that could cause difficulty fitting into the outer canister. The recall affects 1,753 units distributed worldwide.

    Product
    Medline medical procedure kits labeled as follows: a) C-SECTION CDS, REF CDS983998C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0633-2024·2024-08-21

    Hydrocortisone & Acetic Acid Otic Solution Recalled for Potency and Impurity Failures

    Taro Pharmaceuticals recalled Hydrocortisone 1% & Acetic Acid 2% Otic Solution (lot AD12890) due to failed impurity specifications and lower-than-established active ingredient levels during stability testing.

    Product
    Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-3007-01
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2545-2024·2024-08-21

    Discrete Chemistry Analyzer Recalled Due to Carousel Malfunction

    Beckman Coulter is recalling 59 units of its Access 2 Immunoassay System Analyzer due to misaligned index wheels causing carousel motion errors that disable the analyzer and cancel patient tests.

    Product
    Discrete photometric chemistry analyzer for clinical use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1731-2024·2024-08-21

    Pariva Marinated Labneh Bites Recalled for Potential Mold Contamination

    Pariva LLC recalls Marinated Labneh Bites due to potential mold contamination. Approximately 4,261 units were distributed across seven states.

    Product
    Pariva Marinated Labneh Bites Rosemary Garlic; NET WT 8 OZ (225g); INGREDIENTS: YOGURT (CULTURED PASTEURIZED GRADE A MILK & CREAM, SKIM MILK, WHEY PROTEIN CONCENTRATE, SALT AND PECTIN), *SUNFLOWER OIL, *EXTRA VIRGIN OLIVE OIL, ROSEMARY SPICES; CONTAINS: MILK, Distributed by, Mayu
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2622-2024·2024-08-21

    Salivary Testosterone ELISA Quality Control Failure Invalidates Test Results

    DRG International is recalling Salivary Testosterone ELISA kits (Model SLV-3013) due to out-of-range quality controls that invalidate test runs and delay patient results. The recall affects 257 units distributed nationwide in six states.

    Product
    Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2638-2024·2024-08-21

    PICC Catheter Package Contains Wrong Length, Causing Procedural Delay

    Argon Medical Devices recalls PICC catheters that are mislabeled. Packages marked 26G/1.9Fr x 30cm actually contain 26G/1.9Fr x 50cm catheters, which could delay procedures.

    Product
    L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2580-2024·2024-08-21

    VITROS Folate Reagent Pack Recalled for Delayed Test Results

    Ortho-Clinical Diagnostics is recalling VITROS Folate Reagent Pack due to fibrinogen precipitation causing delayed test results. The recall affects 18,467 units distributed worldwide.

    Product
    VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1705-2024·2024-08-21

    Fox's u-bet Vanilla Syrup Recalled for Potential Microbiological Contamination

    SUBCO Foods is recalling Fox's u-bet Vanilla Flavored Syrup due to bloated bottles and elevated pH and water activity levels that indicate potential microbiological contamination and food-borne illness risk.

    Product
    Fox's u-bet Vanilla Flavored Syrup, 20oz, UPC 070216241016, 12 retail units per wholesale case
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-1634-2024·2024-08-14

    Urban River Spirits Cocktail Mixer Recalled for Potential Under-Processing

    Urban River Spirits Crisp Cucumber and Mint cocktail mixer recalled due to production in an unlicensed, uninspected facility. Potential under-processing poses a safety risk.

    Product
    Crisp Cucumber and Mint is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1626-2024·2024-08-14

    Non-alcoholic cocktail mixer recalled for potential under-processing

    Urban River Spirits is recalling Lush Lavender & Wildberry Spritz non-alcoholic mixer due to potential under-processing. The product was manufactured in an unlicensed and uninspected facility.

    Product
    Lush Lavender & Wildberry Spritz is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1619-2024·2024-08-14

    Urban River Spirits Grapefruit Mixer Recalled for Potential Under-Processing

    Urban River Spirits is recalling Ruby-Red Grapefruit Mixer due to potential under-processing of the non-alcoholic beverage made in an unlicensed facility. No illnesses have been reported.

    Product
    Ruby-Red Grapefruit Mixer is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    0 states