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.

18276–18300 of 21645

  • ModerateFDA (Devices)·Z-1792-2014·2014-06-25

    Roche cobas 8000 Analyzer Filters Recalled for Potential Performance Issues

    Roche Diagnostics is recalling cobas 8000 analyzer filters that may cause discrepant results, alarms, or foam under certain conditions.

    Product
    cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1384-2014·2014-06-25

    Thorne Research Recalls Captomer-250 Capsules Marketed Without Approval

    Thorne Research is recalling Captomer-250 capsules because they are marketed as dietary supplements but contain DMSA, an active drug ingredient, making them unapproved new drugs.

    Product
    Captomer-250 [succinic acid (from 250 mg DMSA)] capsules, 162 mg, 45-count bottles, Manufactured By: Thorne Research, Inc., P.O. Box 25, Dover, Idaho 83825, UPC 6 93749 73502 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1799-2014·2014-06-25

    Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters

    Boston Scientific is recalling 968 IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.

    Product
    IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2042-2014·2014-06-25

    Kodiak Wild Alaska Seafood Recalls Unpermitted Frozen Pacific Halibut Fillets

    Kodiak Wild Alaska Seafood is recalling 42 pounds of frozen Pacific halibut fillets because the firm operated without a required permit or HACCP controls.

    Product
    Pacific halibut, skin-on boneless fillet; vacuum packaged in a clear plastic bag. The wt of the fish is the only labeling included on the product..
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1834-2014·2014-06-25

    NIPRO Safe Touch Safety Scalp Vein Set Recalled for Potential Cracks

    Nipro Medical Corporation is recalling NIPRO Safe Touch Safety Scalp Vein Sets because a crack in the connector could cause fluid leakage.

    Product
    NIPRO Safe Touch Safety Scalp Vein Set
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1789-2014·2014-06-25

    Philips Smart Monitor 2 Professional Series Infant Apnea Monitor Recall

    Children's Medical Ventures is recalling 112 infant apnea monitors due to a battery wire harness defect that renders the devices inoperable.

    Product
    Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1801-2014·2014-06-25

    Biomet Recalls EZPass Suture Retriever Due to Nitinol Wire Buckling

    Biomet is recalling 100 units of EZPass Suture Retriever instruments because the nitinol wire may buckle and become kinked, making the device difficult to use.

    Product
    EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1795-2014·2014-06-25

    Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters

    Boston Scientific is recalling 968 IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.

    Product
    IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1802-2014·2014-06-25

    Biomet Recalls EZPass Nylon Monofilament Suture Passers Due to Buckling

    Biomet is recalling 100 units of EZPass Nylon Monofilament Suture Passers because the internal wire may buckle, making the instrument difficult to use.

    Product
    EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1790-2014·2014-06-25

    Roche MODULAR ANALYTICS EVO Serum Work Area Filter Recall

    Roche Diagnostics is recalling 462 Serum Work Area filters for the MODULAR ANALYTICS EVO analyzer due to potential loose components that may cause discrepant results and system alarms.

    Product
    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1804-2014·2014-06-25

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products Calibrator Kit 17

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 17 because calibrator values were assigned using a reference method that was not fully validated.

    Product
    VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·040-2014·2014-06-25

    Rudolph Foods Recalls Pork Cracklins Due to Undeclared MSG

    Rudolph Foods is recalling 34 pounds of pork cracklins because the product contains monosodium glutamate (MSG), which is not declared on the label.

    Product
    Rudolph Foods Company — Recall Notification Report 040-2014 (Pork Products)
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1797-2014·2014-06-25

    Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters

    Boston Scientific is recalling IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.

    Product
    IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1833-2014·2014-06-25

    Synthes External Fixation Systems Recalled for MR Labeling Changes

    Synthes, Inc. is recalling external fixation systems because labeling changes were made to reflect updated protocols for Magnetic Resonance (MR) imaging safety designations.

    Product
    Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2031-2014·2014-06-25

    Nutri-West Recalls Total Enzyme and Probiotics Due to Chloramphenicol Risk

    Nutri-West is voluntarily recalling Total Enzyme and Total Probiotics supplements because raw materials may contain Chloramphenicol.

    Product
    Total Enzyme, Dietary Supplement, Nutri-West, 120 capsules, Servicing Size 1 Capsule
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1765-2014·2014-06-18

    Stryker Recalls Zyphr Elite Round Fluted Bur Due to Missing Notches

    Stryker is recalling four sterile Zyphr Elite Round Fluted Burs because some units may have missing or partial notches, potentially affecting their use with Elite Attachments.

    Product
    Stryker 2.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1774-2014·2014-06-18

    Stryker Neuro Drill Accessories Recalled for Missing Notches

    Stryker is recalling 41 sterile neuro drill accessories due to missing or partial notches that may affect compatibility with Elite attachments.

    Product
    Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1755-2014·2014-06-18

    Stryker 5.5mm Round Fluted Bur Recall Due to Missing Notches

    Stryker is recalling 99 sterile 5.5mm Round Fluted Bur Soft Touch devices because some units may have missing or partial notches.

    Product
    Stryker 5.5mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1764-2014·2014-06-18

    Stryker Recalls Zyphr Elite Round Fluted Bur Due to Missing Notches

    Stryker is recalling 107 sterile Zyphr Elite Round Fluted Burs because some units may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 6.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1772-2014·2014-06-18

    Stryker 1.3mm Wire Pass Drill Recalled for Missing Notches

    Stryker is recalling 176 sterile 1.3mm Wire Pass Drills because some units may have missing or partial notches.

    Product
    Stryker 1.3mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1760-2014·2014-06-18

    Stryker Round Fluted Bur Recall Due to Missing Notches

    Stryker is recalling 301 sterile 6.0mm Round Fluted Bur Aggressive devices because some units have missing or partial notches.

    Product
    Stryker 6.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1769-2014·2014-06-18

    Stryker 5.0mm Acorn Bur Recalled for Missing Notches

    Stryker is recalling 71 units of 5.0mm Acorn Bur sterile cutting accessories due to missing or partial notches.

    Product
    Stryker 5.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1762-2014·2014-06-18

    Stryker Zyphr Elite Round Fluted Bur Recall for Missing Notches

    Stryker is recalling 39 sterile Zyphr Elite Round Fluted Burs because some units may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 3.5mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1758-2014·2014-06-18

    Stryker 5.0mm Round Fluted Bur Recall Due to Missing Notches

    Stryker is recalling 1,537 sterile 5.0mm Round Fluted Bur Aggressive devices because some units have missing, partial, or no notches.

    Product
    Stryker 5.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1739-2014·2014-06-18

    Fresenius NaturaLyte Liquid Bicarbonate Concentrate Recalled for Manganese Contamination

    Fresenius Medical Care is recalling NaturaLyte Liquid Bicarbonate Concentrate bottles because the container caps may contain foreign material with elevated manganese levels.

    Product
    NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
    Category
    Medical Device
    Distribution
    1 state