The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

42576–42600 of 50511

  • HighFDA (Devices)·Z-0181-2014·2013-11-13

    Siemens Healthcare Recalls Emit 2000 Phenobarbital Assay Due to Imprecision

    Siemens Healthcare Diagnostics is recalling specific lots of the Emit 2000 Phenobarbital Assay because they may produce imprecise results. The recall covers units distributed in the US and Mexico.

    Product
    Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0175-2014·2013-11-13

    Mesa Laboratories Recalls pH 7.0 Buffer Solution Due to Mold Growth

    Mesa Laboratories is recalling specific lots of pH 7.0 Buffer Solution bottles because of mold growth. The product is used to calibrate pH meters in hemodialysis settings.

    Product
    pH 7.0 Buffer Solution Pint and Quart Bottles, Part Number 02.0030 for Pints and 02.0031 for Quarts. Packaged in Plastic Bottles. Can be sold individually or in cartons with 6 bottles per box (for quart bottles only). Used in the hemodialysis setting to calibrate pH meters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0127-2014·2013-11-13

    Stryker Recalls Dekompressor Percutaneous Discectomy Probes Due to Fracture Risk

    Stryker is recalling Dekompressor Percutaneous Discectomy Probes because the auger or cannula may fracture if the device is manually bent, potentially requiring additional medical intervention.

    Product
    Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus material.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0164-2014·2013-11-13

    Smiths Medical Recalls Portex Spinal Trays with Particulate Contamination

    Smiths Medical is recalling Portex Spinal Anaesthesia Trays because visual particulate was found in the included Lidocaine and Dextrose ampules.

    Product
    Portex¿ Saddleblock Tray with Drugs  25g Quincke; 4795-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0142-2014·2013-11-13

    Sorin Recalls S5 Heart-Lung Machines Due to Cardioplegia Control Malfunction

    Sorin Group is recalling 84 S5 Heart-Lung Machines because of a malfunction in the cardioplegia control system.

    Product
    S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-0119-2014·2013-11-13

    Irwin Naturals Recalls Dual Action Cleanse Due to Chloramphenicol Contamination

    Irwin Naturals is recalling Dual Action Cleanse and Daily Digestive Enzymes because they may be contaminated with chloramphenicol.

    Product
    Dual Action Cleanse by Cellular Research Formulas with Green Tea Bonus 60 ct, Item AN056906E, UPC Code: 7 10363 56906 8
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0106-2014·2013-11-13

    Gladiola White Cornbread Mix Recalled for Aflatoxin Contamination

    JM Smucker is recalling Gladiola White Cornbread Mix because independent testing found aflatoxin levels exceeding FDA specifications.

    Product
    Gladiola¿ White Cornbread Mix, Net Wt 6 oz (170g) Laminated Pouch Mfg Code 3101 501 BEST IF USED BY: 11 APR 14 Product labeled in part, INGREDIENTS: ENRICHED DEGERMINATED WHITE CORN MEAL, AND ENRICHED BLEACHED FLOUR***PARTIALLY DEHYDROGENATED SOYBEAN OIL, DEXTROSE, BAKING…
    Category
    Food
    Distribution
    33 states
  • HighFDA (Food)·F-0109-2014·2013-11-13

    Martha White Corn Meal Mix Recalled for Aflatoxin Levels

    J M Smucker Co is recalling Martha White Self-Rising Buttermilk Corn Meal Mix because independent testing found aflatoxin levels exceeding FDA specifications.

    Product
    Martha White¿ SELF-RISING BUTTERMILK CORN MEAL MIX White-Enriched Hot Rize NET WT 32 OZ (2 LB) 907g Paper Bag Mfg Code 3151 511 BEST IF USED BY: 31 JAN 14 Product labeled in part, INGREDIENTS: ENRICHED WHITE CORN MEAL, WHEAT FLOUR AND DEGERMINATED WHITE CORN MEAL***BAKING…
    Category
    Food
    Distribution
    33 states
  • HighFDA (Devices)·Z-0171-2014·2013-11-13

    Handicare Bath Bliss Handset Recall for Inoperable Lifts

    Handicare Accessibility is recalling 3,301 handsets for Minivator Bath Bliss Reclining Bath Lifts because two units became inoperable while users were in the tub.

    Product
    Handset component of the Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), Part Number BP300-100/BP300-400RSUS (handset) - Model Numbers BBR0311USAB (blue) and BBR0311USSS (silver) Handset component devices operate the Minivator Bath Bliss Reclining Bath…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2014·2013-11-13

    Portex Spinal Trays Recalled Due to Visual Particulate in Lidocaine Ampules

    Smiths Medical ASD is recalling 73 Portex Spinal Trays because visual particulate was found in the included Lidocaine HCL ampules.

    Product
    Portex¿ Spinal Tray with Drugs 22g/25g Quincke; 15249-21 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0147-2014·2013-11-13

    Beckman Coulter Recalls UniCel DxH 800 and DxH 600 Hematology Analyzers

    Beckman Coulter is recalling 1,025 UniCel DxH 800 and DxH 600 hematology analyzers because specific check valves may fail, potentially causing air or liquid leaks.

    Product
    UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0016-2014·2013-11-13

    Siemens Fluoroscopic X-Ray Systems Recalled for Potential Radiation Malfunction

    Siemens is recalling 23 fluoroscopic X-ray systems due to a potential malfunction that may cause radiation to continue longer than expected, resulting in unnecessary dose.

    Product
    Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0158-2014·2013-11-13

    Smiths Medical Recalls Portex Spinal Trays with Particulate Contamination

    Smiths Medical ASD, Inc. is recalling Portex Spinal Trays because visual particulate was found in the included Lidocaine and Dextrose ampules.

    Product
    Portex¿ Spinal Tray with Drugs 25g Whitacre; 15545C-21 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0150-2014·2013-11-13

    Ethicon Adjustable Gastric Band Recalled for Force to Lock Failure

    Ethicon Endo-Surgery Inc is recalling 2,475 Adjustable Gastric Bands because aging studies showed they failed to meet Force to Lock test requirements.

    Product
    Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of morbid obesity
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0134-2014·2013-11-13

    Edwards Lifesciences Recalls Fem-Flex Femoral Arterial Cannulas Due to Cracks

    Edwards Lifesciences is recalling two lots of Fem-Flex Femoral Arterial Cannulas because cracks were found in the t-connectors during product evaluation.

    Product
    Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usage: Edwards Lifesciences femoral access cannulae are intended for use in situations which require rapid femoral venous and arterial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13E061000·2013-11-12

    Seat Belt Assemblies Recalled for Non-Compliant Latch Plate Release Mechanism

    Indiana Mills and Manufacturing Inc. is recalling seat belt assemblies manufactured between August and October 2013 that may fail to release properly, potentially hindering vehicle egress during emergencies.

    Product
    SEAT BELTS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V559000·2013-11-07

    Starcraft Recalls 2013 RT and Comet Trailers for Roof Collapse Risk

    Starcraft RV is recalling 2013 RT and Comet pop-up camping trailers because a roof lifter failure could cause the roof to collapse, increasing injury risk.

    Product
    STARCRAFT — STARCRAFT COMET, STARCRAFT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13E067000·2013-11-07

    Lippert Travel Trailer Doors Recalled for Deadbolt Jamming Risk

    Lippert is recalling 2006-2013 travel trailer doors with Fastec deadbolts that may jam, potentially trapping occupants inside the vehicle.

    Product
    LATCHES/LOCKS/LINKAGES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide