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.

11051–11075 of 21617

  • ModerateFDA (Devices)·Z-0852-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch + Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, CRESCENT BLADE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE E7510, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0950-2018·2018-03-14

    Springside Monterey Jack Chicken Soup Cheese Recalled for Pasteurization Issue

    Springside Cheese Corp is recalling Monterey Jack Chicken Soup Cheese because it may have been made with milk held for 13.8 seconds during pasteurization.

    Product
    Springside Monterey Jack Chicken Soup Cheese Packaged in the following sizes: Net Wt. 1 lb. and 40 lbs.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0929-2018·2018-03-14

    Euro Diagnostica Recalls DIASTAT ANA ELISA Kits Due to False Positives

    Euro Diagnostica is recalling 1,090 units of DIASTAT ANA ELISA kits because high background levels may cause false positive test results.

    Product
    DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0877-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch + Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 2.85MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7553A, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0899-2018·2018-03-14

    Medical Device Recall: Silicone Fluted Round Drain and Connector

    Degania Silicone, Ltd. is recalling Silicone Fluted Round Drain 24Fr and Connector units because sterile pouches are missing labels. The boxes are properly labeled, and only lot P1607442 is affected.

    Product
    Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0836-2018·2018-03-14

    Stryker AHTO Tube Set Recalled for High Bioburden Levels

    Stryker is recalling AHTO Tube Sets labeled sterile because routine testing found bioburden levels higher than internal acceptable rates.

    Product
    STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryker AHTO Tube Set with Tip Packaging (Model 0250070620);
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0945-2018·2018-03-14

    Springside Monterey Jack Cheese Recalled for Pasteurization Issue

    Springside Cheese Corp is recalling Monterey Jack Onion & Chives Cheese because it may have been made with milk held for 13.8 seconds during pasteurization.

    Product
    Springside Monterey Jack Onion & Chives Cheese Net Wt. 1 lb.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0924-2018·2018-03-14

    Wiener Lab Chagas Disease Diagnostic Test Recalled for Expiration Concerns

    Wiener Laboratories is recalling CHAGATEST ELISA RECOMBINANTE V. 3.0 diagnostic tests because internal testing suggests they may not reach their indicated expiration dates.

    Product
    Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0859-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch & Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 20 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7520, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0876-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch & Lomb is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 2.8MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7552ADB, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0855-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, CRESCENT KNIFE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE E7510G, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0870-2018·2018-03-14

    Bausch + Lomb Recalls LASEREDGE Knives Due to Dull Blades

    Bausch + Lomb is voluntarily recalling LASEREDGE Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 2.6 MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7550ADB, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0879-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7556ADB, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0915-2018·2018-03-14

    Ortho-Clinical VITROS DAT Performance Verifier V Recall for Storage Labeling Issues

    Ortho-Clinical Diagnostics is recalling VITROS DAT Performance Verifier V units due to storage labeling errors that may cause lower than expected VITROS BENZ results.

    Product
    VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0867-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch + Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 2.2 MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7548ADB, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0898-2018·2018-03-14

    Boston Scientific Recalls Auriga XL 4007 Laser Systems Due to Assembly Defect

    Boston Scientific is recalling nine Auriga XL 4007 Laser Systems because incorrectly assembled trigger wire components may cause error codes or prevent the consoles from starting.

    Product
    Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0862-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints

    Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives used in ophthalmic surgery due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.85 (6/BOX), REF/PRODUCT CODE E7528, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0853-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints

    Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, CRESCENT BLADE ANGLED TIP BEVEL UP (6/BOX), REF/PRODUCT CODE E7510AT, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0861-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch & Lomb is voluntarily recalling specific LaserEdge ophthalmic knives due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75 (6/BOX), REF/PRODUCT CODE E7527, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0868-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints

    Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of dull blade complaints.

    Product
    LASEREDGE Knives, 2.4 MM SLIT KNIFE ANGLED DOUBLE BEVEL, REF/PRODUCT CODE E7549ADB, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0866-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch + Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because an atypical volume of complaints reported dull blades.

    Product
    LASEREDGE Knives, 30 DEGREE STAB BLADE TIP (6/BOX), REF/PRODUCT CODE E7530T, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0882-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Knives Due to Dull Blades

    Bausch & Lomb is voluntarily recalling LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 3.2MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7557A, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0913-2018·2018-03-14

    Ortho-Clinical Recalls VITROS DAT Performance Verifier III Due to Labeling Error

    Ortho-Clinical Diagnostics is recalling 180 units of VITROS DAT Performance Verifier III because incorrect storage labeling may cause lower than expected test results.

    Product
    VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide