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.

10401–10425 of 21617

  • ModerateFDA (Drugs)·D-0850-2018·2018-06-20

    Geritrex Senna Syrup Recalled for Microbial Contamination

    RIJ Pharmaceutical LLC is recalling Geritrex Senna Syrup due to out-of-specification microbial counts in a water sample.

    Product
    Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle, Distributed by Geritrex, LLC 144 Kingsbridge Rd East Mt Vernon, NY 10550, 1-800-736-3437, NDC 54162-007-08, UPC 354162007088
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2167-2018·2018-06-20

    BioMérieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Temperature Excursion

    BioMérieux is recalling VITEK 2 Gram Positive Susceptibility Cards in Guadeloupe because a shipment experienced a temperature excursion up to 47.8°C, exceeding acceptable limits.

    Product
    The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents. Fully automated short
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2144-2018·2018-06-20

    Philips IntelliVue MX40 Patient Monitor Recall for Missing Warning Statements

    Philips is recalling 94 IntelliVue MX40 Patient Monitors because five warning statements are missing from the instructions for use.

    Product
    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146
    Category
    Medical Device
    Distribution
    53 states
  • ModerateFDA (Devices)·Z-2163-2018·2018-06-20

    Smith & Nephew Recalls GENESIS II Tibial Punches Due to Size Defect

    Smith & Nephew is recalling 5 units of GENESIS II 13 mm tibial punches because they are 2 mm smaller than the specified size.

    Product
    smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1576-2018·2018-06-20

    Yukon Jackson Recalls Herd of Turtles Milk Chocolate for Allergen Labeling Error

    Yukon Jackson is recalling Herd of Turtles milk chocolate because pecans are listed in the ingredients but missing from the 'Contains' statement.

    Product
    Herd of Turtles confection milk chocolate, 4 oz. and 8 oz. packages. UPC of 4 oz: 6 55974 89004 3. UPC of 8 oz: 6 55974 89008 1. The label is read in parts: "***INGREDIENTS: MILK CHOCOLATE 35% (SUGAR, COCOA BUTTER, WHOLE MILK POWDER, EMULSIFIER, SOYA LECITHIN, VANILLA), C
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2137-2018·2018-06-20

    Thermo Fisher Recalls Remel SUPERPACK CS/ 500 SEG/FLASK Due to Performance Failure

    Thermo Fisher is recalling 67 units of Remel SUPERPACK CS/ 500 SEG/FLASK because the product may fail performance testing for Staphylococcus aureus.

    Product
    remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0842-2018·2018-06-20

    RIJ Pharmaceutical Recalls Antacid Due to Microbial Count Deviation

    RIJ Pharmaceutical LLC is recalling Preferred Plus Pharmacy Antacid Extra Strength due to out-of-specification microbial counts in a water sample.

    Product
    Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Magnesium Hydroxide 400mg, Simethicone 40 mg), packaged in 12 FL. OZ. (355 mL), Manufactured By: RIJ Pharmaceutical Corp.40 Commercial Avenue, Middletown, NY 10941, Distributed by: Kinray Inc. Whitestone,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0844-2018·2018-06-20

    RIJ Pharmaceutical Recalls Senna Syrup Due to Microbial Contamination

    RIJ Pharmaceutical LLC is recalling RPC Senna Syrup due to out-of-specification microbial counts in a water sample.

    Product
    RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NJ 10941, NDC 5380755608, UPC 353807556080
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·050-2018·2018-06-14

    Winter Sausage Manufacturing Recalls Poultry and Meat Products for Misbranding

    Winter Sausage Manufacturing Co. is recalling poultry, pork, and beef products because religious exemption slaughter was not declared on the labels.

    Product
    Winter Sausage Manufacturing Company Inc. — Winter Sausage Manufacturing Co. Recalls Poultry and Meat Products due to Misbranding
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2080-2018·2018-06-13

    Tosoh ST-AIA PACK FT3 Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK FT3 assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate thyroid results.

    Product
    ST-AIA PACK FT3; Part Number: 025286 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2054-2018·2018-06-13

    Siemens ADVIA Centaur TSH3-Ultra Assay Recalled for Analyzer Compatibility Issues

    Siemens is recalling specific lots of ADVIA Centaur TSH3-Ultra assays because they may cause reduced dilution recovery or inoperability when used with Multi-Diluent 15 on certain analyzers.

    Product
    ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests)
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Food)·F-1529-2018·2018-06-13

    Driscoll's Blackberries Recalled for Pesticide Residue Tolerance Exceedances

    Driscoll's is recalling 6 oz. blackberries from Mexico due to pesticide levels exceeding tolerance limits.

    Product
    Driscoll's Blackberries; 6 oz. clamshell container; Keep refrigerated. Product of Mexico Driscoll's Inc. Watsonville, CA 95077
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2057-2018·2018-06-13

    Stryker Recalls Expired Arthroscopic Cannulas Due to Labeling Error

    Stryker is recalling 10 units of 8.0mm x 90mm Dri-Lok Threaded Cannulas because the expiration date was misprinted as August 2018 instead of August 2016.

    Product
    3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cannula device is designed to be used as a port of entry for arthroscopic instruments into the joints.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2112-2018·2018-06-13

    Baxter SIGMA Spectrum Infusion Pump Recall for Instructional Mismatch

    Baxter is recalling SIGMA Spectrum Infusion Pumps because the instructions for use specify a 20-inch bag drop, but the firm supplies 12.5-inch hangers.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2067-2018·2018-06-13

    Tosoh Tumor Marker Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK PA tumor marker assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2092-2018·2018-06-13

    Tosoh ST-AIA SHBG Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA SHBG assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2113-2018·2018-06-13

    Baxter SIGMA Spectrum Infusion Pump Instructions for Use Update

    Baxter Healthcare is updating the Instructions for Use for SIGMA Spectrum Infusion Pumps to correct a discrepancy regarding the height of secondary infusion hangers.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include phar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2091-2018·2018-06-13

    Tosoh ST-AIA PACK Prog II Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK Prog II assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2068-2018·2018-06-13

    Tosoh ST-AIA Prostate Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA Prostate Assay kits because the drug Strensiq can cause inaccurate test results.

    Product
    ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2115-2018·2018-06-13

    Invivo Xper Flex Cardio Physiomonitoring System Recalled for Software Defect

    Invivo Corporation is recalling Xper Flex Cardio Physiomonitoring Systems because users may inadvertently close the Full Disclosure Control Window using the ESC key.

    Product
    Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2085-2018·2018-06-13

    Tosoh ST-AIA DHEA-S Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA DHEA-S assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide