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.

34751–34775 of 50502

  • HighFDA (Food)·F-2099-2016·2016-09-14

    Dannon Recalls Activia Fiber Yogurt Due to Incorrect Gluten-Free Labeling

    The Dannon Company is recalling Activia FIBER Lowfat Yogurt because the packaging displays a Certified Gluten-Free mark despite containing wheat.

    Product
    Activia FIBER Lowfat Yogurt Strawberry/Pineapple Flavors 12 Packs of 4 OZ Cups UPC 3663202884 packaged in form fill seal plastic cups
    Category
    Food
    Distribution
    33 states
  • HighFDA (Food)·F-2064-2016·2016-09-14

    Bakery Express Recalls 7-Eleven Walnut Fudge Brownies for Undeclared Allergen

    Bakery Express is recalling 7-Eleven Fresh To Go Walnut Fudge Brownies due to an undeclared walnut allergen caused by incorrect labeling.

    Product
    7-Eleven, Fresh To Go, Walnut Fudge Brownie Net weight: 3.8 Ounces, Number of units per package: One Shelf life: Three Days Expiration date: 0708 (July 8, 2016)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2722-2016·2016-09-14

    Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm

    Hospira Inc. is recalling 357,778 Plum A+ Hyperbaric Infusion Pumps because an undersized fluid shield diaphragm may cause alarms or therapy interruptions.

    Product
    Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2736-2016·2016-09-14

    Philips BrightView XCT Gamma Camera Recalled for Software Defect

    Philips Medical Systems is recalling 424 BrightView XCT gamma cameras due to a software defect that may cause the detector to contact patients during specific scans.

    Product
    BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2055-2016·2016-09-14

    Oatmeal Pancake Mix Recalled for Undeclared Soy Allergen

    Productos La Finca, Inc. is recalling Maga Oatmeal Pancakes due to undeclared soy lecithin. The product was distributed in Puerto Rico.

    Product
    Product label reads in part: "Maga PANCAKES DE AVENA***OATMEAL PANCAKES***Peso Neto/Net Weight 16 oz (454.8gr)***Productos La Finca, Inc.*** Zona Ind. Machuchal*** Avenida Quilinchini #61***Sabana Grande, Puerto Rico 00637"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2745-2016·2016-09-14

    Smith & Nephew Whipknot Soft Tissue Cinch Suture Recalled for Sterility Breach

    Smith & Nephew is recalling Whipknot Soft Tissue Cinch sutures because sterile packaging was breached, compromising sterility. The recall covers 34,065 units distributed worldwide.

    Product
    Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during ligament reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16262·2016-09-14

    Zeagle Buoyancy Control Devices Recalled for Drowning Hazard

    Huish Outdoors is recalling Zeagle Grace and Element BCDs because they may leak air, causing loss of flotation and posing a drowning risk to scuba divers.

    Product
    Zeagle brand buoyancy control devices (BCDs)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2761-2016·2016-09-14

    Riverpoint Medical Recalls Nylon Surgical Sutures Due to Seal Integrity Issues

    Riverpoint Medical is recalling sterile nylon surgical sutures because the seals may become open during distribution or packaging.

    Product
    Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers: 663BK 663BL 664BL 928BK Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2728-2016·2016-09-14

    Hospira Recalls Plum A+3 Infusion Pumps Due to Undersized Diaphragm

    Hospira is recalling 357,778 Plum A+3 Infusion Pump Systems because an undersized fluid shield diaphragm may cause alarms and interrupt therapy.

    Product
    Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2068-2016·2016-09-14

    Nature Made Gummy Multivitamin Recalled for Possible Salmonella Contamination

    Pharmavite is recalling specific lots of Nature Made adult gummy multivitamins due to possible Salmonella contamination. Consumers should check their lot numbers and expiration dates.

    Product
    Nature Made(R) adult gummies Multi for Her plus Omega-3, 100 count, UPC 0-31604-04236-3
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2098-2016·2016-09-14

    McCain Foods Recalls Fire Roasted Poblano and Jalapeno Popper Bites

    McCain Foods USA is recalling Fire Roasted Poblano & Jalapeno popper bites because the flour used was contaminated with E. Coli O121.

    Product
    Fire roasted Poblano & Jalapeno popper bites packaged in a white box with black lettering. The product is labeled in part: Canchor Poppers Fire Roasted & Jalapeno popper bites, 2-4 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2724-2016·2016-09-14

    Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm

    Hospira is recalling 357,778 Plum A+ Infusion Pumps because an undersized fluid shield diaphragm may cause alarms and delay or interrupt therapy.

    Product
    Plum A+ Infusion Pump. List Number 11973. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2721-2016·2016-09-14

    Elekta Medical Linear Accelerator Recall for Loose Drive Gear Joint

    Elekta is recalling 553 Medical Linear Accelerators because a loose joint between the drive gear and gantry base drive wheel can lead to fatigue failure of securing bolts.

    Product
    Medical Linear Accelerator
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-2749-2016·2016-09-14

    Boston Scientific Recalls Five Unapproved MRI Pacemakers

    Boston Scientific is recalling five implanted pacemakers that used an unapproved module configuration. The devices were shipped to customers in five states.

    Product
    Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·F-2053-2016·2016-09-14

    Maga Pancake and Waffle Mix Recalled for Undeclared Soy Lecithin

    Productos La Finca, Inc. is recalling Maga Pancake and Waffle Mix because the product contains soy lecithin, an allergen not listed on the label.

    Product
    Product label reads in part: "Maga PANCAKES EL ORIGINAL***PANCAKE & WAFFLE MIX***Peso Neto/Net Weight 16 oz (454.8gr)***Productos La Finca, Inc.*** Zona Ind. Machuchal*** Avenida Quilinchini #61***Sabana Grande, Puerto Rico 00637"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2056-2016·2016-09-14

    Maga Pancakes Recalled for Undeclared Soy Allergen

    Productos La Finca, Inc. is recalling Maga Pancakes Cinnamon Brown Sugar in Puerto Rico due to an undeclared soy allergen.

    Product
    Product label reads in part: "Maga PANCAKES CINNAMON BROWN SUGAR***Peso Neto/Net Weight 16 oz (454.8gr)***Productos La Finca, Inc.*** Zona Ind. Machuchal*** Avenida Quilinchini #61***Sabana Grande, Puerto Rico 00637"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2730-2016·2016-09-14

    Hospira Recalls Plum A+3 Infusion Pumps Due to Undersized Diaphragm

    Hospira is recalling 357,778 Plum A+3 Infusion Pumps because an undersized fluid shield diaphragm may cause alarms or therapy interruption.

    Product
    Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2061-2016·2016-09-14

    Maga Cocoa Pancake Mix Recalled for Undeclared Soy Lecithin

    Productos La Finca, Inc. is recalling 153 boxes of Maga Cocoa Pancake Mix because the product contains soy lecithin, an undeclared allergen.

    Product
    Product label reads in part: "Maga PANCAKES COCOA***Peso Neto/Net Weight 16 oz (454.8gr)***Productos La Finca, Inc.*** Zona Ind. Machuchal*** Avenida Quilinchini #61***Sabana Grande, Puerto Rico 00637"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2057-2016·2016-09-14

    Maga White Whole Grain Pancakes Recalled for Undeclared Soy Lecithin

    Productos La Finca, Inc. is recalling Maga White Whole Grain Pancakes in Puerto Rico because the product contains soy lecithin, an undeclared allergen.

    Product
    Product label reads in part: "Maga PANCAKES INTEGRAL BLANCO***WHITE WHOLE GRAIN PANCAKES***Peso Neto/Net Weight 16 oz (454.8gr)***Productos La Finca, Inc.*** Zona Ind. Machuchal*** Avenida Quilinchini #61***Sabana Grande, Puerto Rico 00637"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2037-2016·2016-09-14

    Odyssey King Crab Legs Recalled for Listeria Contamination

    Odyssey Enterprises Inc. is recalling Split Cooked King Crab Leg & Claw due to Listeria monocytogenes contamination. The product was distributed in Wisconsin.

    Product
    Split Cooked King Crab Leg & Claw, repacked by Odyssey, net wt. 20 lbs. per box, keep frozen. UPC 28575 96323 The label is read in parts: "***SPLIT COOKED KING CRAB LEG & CLAW***PRODUCT OF RUSSIA***PACKED IN U.S.A. ***NET WT. 20 LBS***KEEP FROZEN***PACKED FOR: ODYSSEY BY…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2750-2016·2016-09-14

    Hill-Rom Recalls 94 Affinity Four Birthing Beds Due to Defect

    Hill-Rom is voluntarily recalling 94 Affinity Four Birthing Beds (Model P3700) distributed in the US and abroad. The recall was initiated by the firm.

    Product
    Affinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and utilizes a metal packing brace, standard corrugated cardboard and plastic banding. When possible these beds are shipped as a quantity of two (2) together as shown with the nylon strapping.…
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-2723-2016·2016-09-14

    Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm

    Hospira Inc. is recalling 357,778 Plum A+ Infusion Pumps because an undersized fluid shield diaphragm may cause alarms or therapy interruption.

    Product
    Plum A+ Infusion Pump. List Number 11971. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1485-2016·2016-09-14

    Amerisource Recalls Mispackaged Amphetamine Tablets Due to Dosing Errors

    Amerisource Health Services is recalling 156 cartons of 30 mg amphetamine tablets because blister cavities may contain more than one tablet.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 30 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging…
    Category
    Drug
    Distribution
    Distributed nationwide