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.

41626–41650 of 50511

  • HighFDA (Food)·F-1644-2014·2014-03-19

    StoneWall Kitchen Cupcake Mix Recalled for Missing Milk Allergen Labeling

    Raymond-Hadley Corp. is recalling StoneWall Kitchen Chocolate Coconut Cupcake Mix because the packaging fails to list milk as an allergen, despite containing sodium caseinate.

    Product
    STONEWALL KITCHEN brand Chocolate Coconut Cupcake Mix, Net Wt. 22.5 oz. (637.9 g), UPC 7 11381 31535 4 -- DISTRIBUTED BY STONEWALL KITCHEN, STONEWALL LANE, YORK, ME 03909
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1158-2014·2014-03-19

    Smith & Nephew RENASYS-F Foam Dressing Kit Recall for Sealing Issues

    Smith & Nephew is recalling RENASYS-F Foam Dressing Kits with Soft Port due to inadequate sealing that may prevent fluid evacuation and fail to trigger alarms.

    Product
    Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794, 66800795, and 66800796 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1649-2014·2014-03-19

    Morrison's Brown Gravy Mix Recalled for Undeclared Soy Allergen

    C. H. Guenther & Sons, Inc. is recalling Morrison's Brown Gravy Mix mislabeled as pancake mix due to undeclared soy.

    Product
    MORRISON'S BROWN GRAVY MIX, NET WT 13 OZ (369 g) mislabeled as MORRISON'S PANCAKE MIX, NET WT 5 LB (2.27 kg)
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1188-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to a reported issue with the plunger tip. The devices are sterile, single-use, in-vitro diagnostic tools used for drawing arterial blood.

    Product
    G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Japan only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood…
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1172-2014·2014-03-19

    Accumetrics Recalls VerifyNow IIb/IIIa Test Kits Due to Erroneous Results

    Accumetrics is recalling VerifyNow IIb/IIIa test kits because they may report erroneous low platelet aggregation unit results, potentially affecting clinical decisions.

    Product
    VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. Product Usage: The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1197-2014·2014-03-19

    Elekta XiO RPT System Recalled for Incorrect Dose Calculations

    Elekta is recalling the XiO RPT System because dose and monitor unit values are not computed correctly when specific wedges are used with dynamic arcs.

    Product
    XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on screen and in hard-copy, either two or three dimensional…
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1155-2014·2014-03-19

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Shock Delivery Failure

    Philips is recalling HeartStart MRx Monitor/Defibrillators because they may display a Red X during automated tests, indicating a failure that could prevent the delivery of a shock or pacing.

    Product
    Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V135000·2014-03-19

    McNeilus Concrete Mixers Recalled for Falling Extension Chutes

    McNeilus is recalling 2013-2014 Concrete Standard and Bridgemaster V mixers because extension chutes may fall from the rack, creating a road hazard.

    Product
    MCNEILUS — MCNEILUS BRIDGEMASTER V MIXER, STANDARD MIXER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1198-2014·2014-03-19

    GE Healthcare Recalls Infinia Nuclear Medicine Systems for Detector Motion Risk

    GE Healthcare is recalling Infinia and Infinia Hawkeye Nuclear Medicine Systems due to a potential safety issue where the detector may drift toward the patient.

    Product
    GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1182-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to a reported issue with the plunger tip. The devices are sterile, single-use in-vitro diagnostic tools used for drawing arterial blood.

    Product
    4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line.…
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Food)·F-1646-2014·2014-03-19

    Meijer Pretzel Dinner Rolls Recalled for Unlabeled Milk Allergen

    Meijer Distribution is recalling Pretzel Dinner Rolls because milk is not listed as an allergen. People with milk allergies risk serious reactions.

    Product
    Markets of Meijer Pretzel Dinner Roll, 8 count, 14.0 oz ( 0.87 lb) UPC 0-4125099036-9 Ingredients: Enriched Flour ( Wheat Flour, Malted Barley Flour, niacin, iran, thiamine mononitrate....) water, sugar, canola oil, salt, why (milk) , yeast, wheat starch soy lecithin, wheat…
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1151-2014·2014-03-19

    Megadyne Recalls Suction Coagulators Due to Self-Activation Risk

    Megadyne Medical Products is voluntarily recalling specific lots of Hand Control 12FR Suction Coagulators because they may self-activate when connected to a generator.

    Product
    Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek¿ polyester peel pouch, 25 pouches per box. This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU)…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-1647-2014·2014-03-19

    Nicomex Camaron Entero Whole Shrimp Recalled for Undeclared Sulfites

    Nicomex Inc. is recalling Camaron Entero Whole Shrimp due to undeclared sulfites identified by NYSDAM Laboratory analysis.

    Product
    Nicomex Camaron Entero Whole Shrimp Net Wt 1 oz (28.35 grams). Productos Mexicanos Distributed by Nicomex Inc. 88 First Street, Passaic, NJ 07055 Tel. (973) 815-2062. UPC 8 84678 10173 9.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1170-2014·2014-03-19

    Biomet 3i Recalls Dental Torque Driver Kits Due to Sterility Failure

    Biomet 3i is recalling 250 Contra-Angle Torque Driver Kits because the included surgical trays failed to meet required Sterility Assurance Levels during validation testing.

    Product
    Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14132·2014-03-19

    Vera Bradley Recalls Bear Rattles and Bunny Toys for Choking Hazard

    Vera Bradley is recalling about 98,000 Bear Ring Rattles and Bunny stuffed toys because the pom-pom tail can detach, posing a choking hazard to young children.

    Product
    Vera Bradley Bear Ring Rattles and Bunny Stuffed Toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V128000·2014-03-18

    Heartland Recreational Vehicle Recall for Microwave Fire Risk

    Heartland is recalling certain fifth wheel trailers because the installed microwave may start on its own, posing a fire risk if unattended.

    Product
    HEARTLAND — HEARTLAND CYCLONE, LANDMARK, BIGHORN SILVERADO, BIGHORN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14134·2014-03-18

    Schneider Electric Recalls Square D Circuit Breakers Due to Fire Hazard

    Schneider Electric is recalling specific Square D F and K frame circuit breakers because they may fail to trip during overloads, posing fire, burn, and shock risks.

    Product
    Square D branded, molded case F and K frame circuit breakers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V125000·2014-03-17

    Volkswagen Recalls 2012-2013 Passat Vehicles for Loose Headlight Bulbs

    Volkswagen is recalling 2012-2013 Passat vehicles because the low beam headlight bulb may become loose and lose electrical contact, potentially reducing visibility.

    Product
    VOLKSWAGEN — VOLKSWAGEN PASSAT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14723·2014-03-14

    MobilePower Instant Boost 500 Power Packs Recalled for Fire Hazard

    MobilePower is recalling about 9,800 Instant Boost 500 power packs sold by QVC because they can overheat and cause fires. No injuries have been reported.

    Product
    MobilePower Instant Boost 500 power packs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V123000·2014-03-14

    Jaguar Recalls 2013 XJ and XF Vehicles for Missing Certification Labels

    Jaguar is recalling 2013 XJ and XF vehicles because they lack required certification labels specifying weight ratings. This non-compliance could lead to vehicle overloading and increased crash risk.

    Product
    JAGUAR — JAGUAR XJ, XF
    Category
    Vehicle
    Distribution
    Distributed nationwide