The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

27176–27200 of 32219

  • SevereFDA (Food)·F-0226-2014·2013-11-27

    Sunny Pine Farm Recalls Organic Black Pepper Garlic Chevre for Pasteurization Concerns

    Sunny Pine Farm is voluntarily recalling Organic Black Pepper Garlic Chevre due to possible improper pasteurization. The product was sold in Washington state.

    Product
    Organic Black Pepper Garlic Chevre is sold in 3 lbs. vacuum plastic bag without labels since it sold to restaurants. However, the retail label is read in parts: "***Organic Goat Dairy***Black Pepper Garlic Chevre***6 oz***SUNNY PINE FARMS***Handcrafted in Twisp, Washington…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0268-2014·2013-11-27

    Medtronic Zinger Steerable Guidewires Recalled for Coating Delamination Risk

    Medtronic Vascular is recalling Zinger Steerable Guidewires because the PTFE coating may delaminate and detach from the device.

    Product
    ZINGER¿ Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S, LVZRXT180J, LVZRXT180S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0221-2014·2013-11-27

    Trader Joe's Caesar Salad Recalled for Undeclared Allergens

    Ghiringhelli Specialty Foods is recalling Trader Joe's Caesar Salads due to undeclared soy, fish, and wheat allergens.

    Product
    Trader Giotto's CAESAR Salad with Caesar Dressing; Perishable, keep refrigerated. Packaged in Net Wt. 8.5 oz (241 g) plastic clamshell. Manufactured for Trader Joe's Manufactured by Ghiringhelli Specialty Foods, inc. Vallejo, CA 94950.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0267-2014·2013-11-27

    Medtronic Thunder Steerable Guidewire Recalled for Coating Delamination Risk

    Medtronic Vascular is recalling 1,205 Thunder Steerable Guidewires because the PTFE coating may delaminate and detach from the device.

    Product
    THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0179-2014·2013-11-27

    Lifeforce Medical Institute Ultra Power Dietary Supplement Recalled for Contamination

    ProThera, Inc. is recalling Lifeforce Medical Institute Ultra Power dietary supplements because the enzyme Xylanase ingredient was found to be contaminated with chloramphenicol.

    Product
    Lifeforce Medical Institute Ultra Power; Optimal Vitamin/Mi neral. Trace Element/Anti-Oxidant Detox Support Dietary Supplement. 10 tablets/Packet and 30 packets/1000cc bottle. Distributed by: Mark Rosenbloom, MD LIFEFORCE Medical Institute 60 Revere Dr., Ste. 820…
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0349-2014·2013-11-27

    Hospira Recalls GemStar Infusion Pumps Due to Pressure Sensor Calibration Drift

    Hospira is recalling GemStar infusion pumps because pressure sensor calibration drift may cause the device to fail occlusion tests or report false errors.

    Product
    The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two…
    Category
    Medical Device
    Distribution
    51 states
  • SevereFDA (Drugs)·D-011-2014·2013-11-27

    Greenstone Recalls Spironolactone Tablets Due to Unapproved Manufacturing Site Change

    Greenstone LLC is recalling 4,848 bottles of Spironolactone 50 mg tablets because the manufacturing site change resulted in an unapproved dissolution profile.

    Product
    Spironolactone tablets, USP 50 mg, Rx only, 100 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5012-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0265-2014·2013-11-27

    Medtronic Vascular Recalls Attain Hybrid Guide Wires Due to Coating Defect

    Medtronic Vascular is recalling 1,674 Attain Hybrid Guide Wires because the PTFE coating may delaminate and detach from the device.

    Product
    ATTAIN HYBRID¿ Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0215-2014·2013-11-27

    New Algae Company Recalls EDGE Dietary Supplement for Undeclared Shark Cartilage

    New Algae Company is recalling EDGE dietary supplement packets because the label fails to declare shark cartilage. The product was distributed nationwide.

    Product
    EDGE, Item number 21-620, dietary supplement, 60 packet per box. The Edge product includes two different packets of capsules - a "Before" packet and an "After" packet. The suggested use for the After packet is one packet (or 6 capsules) per day. The suggested use for…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0262-2014·2013-11-27

    Medtronic Zinger Guidewires Recalled for Coating Delamination Risk

    Medtronic Vascular is recalling Zinger Stainless Steel Workhorse Guidewires because the PTFE coating may delaminate and detach.

    Product
    Zinger¿ Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS, ZNGRMS180HJ, ZNGRMS180HS, ZNGRMS180S, ZNGRS180HJ, ZNGRS180HS, ZNGRS180S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0266-2014·2013-11-27

    Medtronic Cougar Steerable Guidewires Recalled for Coating Delamination Risk

    Medtronic Vascular is recalling 20 units of Cougar Steerable Guidewires because the PTFE coating may delaminate and detach.

    Product
    COUGAR¿ Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0362-2014·2013-11-27

    Ossur Fixed Offset Adapter Recalled for Fatigue Cracks and Separation Risk

    Ossur North America Inc is voluntarily recalling 66 units of the A-642100 Fixed Offset Adapter because the component can develop fatigue cracks and separate completely during normal use.

    Product
    Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the…
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-0348-2014·2013-11-27

    Candela Laser GentleLase Pro Recalled for Unintended Pulse Emission Risk

    Candela Corporation is recalling 1,258 GentleLase Pro laser surgical instruments because they may emit an unintended single pulse before the trigger is pressed, posing an injury risk.

    Product
    Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE, Model number: 9914-00-9040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0370-2014·2013-11-27

    FDA Recalls Medcare Max-500 Patient Lifts Due to Potential Load Failure

    Ergosafe Products LLC is recalling 97 Medcare Max-500 patient stands because the lift might fail with the labeled 500-lb load rating.

    Product
    Medcare Products Max-500 Stand, Total Support, patient stand, model #400006. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. Used for assisting patients/residents to a standing position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0180-2014·2013-11-27

    Pro Thera Dual Detox Dietary Supplement Recalled for Chloramphenicol Contamination

    ProThera, Inc. is recalling Pro Thera Dual Detox Dietary Supplement because the enzyme Xylanase ingredient was found to be contaminated with chloramphenicol.

    Product
    Pro Thera Dual Detox Dietary Supplement; 60 capsules; Chlorella - 500 mg; Broccoli Sprout, dried extract - 60 mg; Enzyme Blend - supplying Beta-Glucanase, Cellulase, Protease, Hemicellulase, Phytase and Xylanase Manufactured by ProThera, Reno, NV,
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-015-2014·2013-11-27

    Affirm XL Nutritional Supplement Recalled for Unapproved Sildenafil Analogue

    Affirm XL is recalling its nutritional supplement because FDA analysis found it contains sulfoaildenafil, an unapproved analogue of sildenafil.

    Product
    Affirm XL Nutritional Supplement, 1 and 10 count blister packs and single pill packs, Manufactured by Dongseo Biopharm Corp., Yongin City, Kyonggi do, Korea, distributed by: Affirm XL, LLC, Ladera Ranch, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0264-2014·2013-11-27

    Medtronic ProVia Crossing Guidewire Recalled for Coating Delamination Risk

    Medtronic Vascular is recalling ProVia Crossing Guidewires because the PTFE coating may delaminate and detach from the device.

    Product
    ProVia¿ CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PROV300HS, 3PROV300SS, 9PROV180HS, 9PROV180SS Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0263-2014·2013-11-27

    Medtronic Thunder Extra Support Guidewire Recalled for Coating Delamination Risk

    Medtronic Vascular is recalling 58 Thunder Extra Support Guidewires because the PTFE coating may delaminate and detach from the device.

    Product
    THUNDER¿ Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, THNDR300S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0218-2014·2013-11-27

    Terri Lynn Deluxe Mixed Nuts Recalled for Undeclared Peanuts

    Terri Lynn Inc. is recalling Deluxe Mixed Nuts with Macadamia because the bags contain undeclared peanuts, posing a risk to people with peanut allergies.

    Product
    Mixed nuts in a plastic bag labeled in part: Deluxe Mixed Nuts with Macadamia; NET WT. 12 OZ. (340 g), 30 LB, 35 LB; P.O. BOX 5118 ELGIN, IL 60121
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0350-2014·2013-11-27

    Hospira Recalls GemStar Infusion Pumps Due to Pressure Sensor Calibration Drift

    Hospira is recalling 43,840 GemStar infusion pumps worldwide because pressure sensor calibration drift may cause the device to fail occlusion tests or issue false alarms.

    Product
    The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two…
    Category
    Medical Device
    Distribution
    51 states
  • SevereFDA (Food)·F-0216-2014·2013-11-27

    Flex Dietary Supplement Recalled for Undeclared Shark Cartilage

    New Algae Company is recalling Flex dietary supplement bottles because the label fails to declare shark cartilage, a potential allergen.

    Product
    Flex, Maximum Flexibility, Item number 21-601, dietary supplement, 90 capsules per bottle. The Flex product is a dietary supplement in capsule form containing vegetable glucosamine HCL, chondroitin sulfate (shark cartilage), organic microalgae (aph. flos-aquae) and chicken…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-013-2014·2013-11-27

    Hospira Recalls Ondansetron Injection Vials Due to Glass Spicules

    Hospira Inc. is recalling 681,400 vials of Ondansetron Injection because glass spicules were found during a site inspection.

    Product
    ONDANSETRON — ONDANSETRON (ONDANSETRON)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0177-2014·2013-11-27

    Bio-Cat Recalls Pectinase Enzyme Blends Due to Chloramphenicol Contamination

    Bio-Cat Inc is recalling bulk pectinase enzyme blends intended for food and dietary supplement manufacturing because they may be contaminated with chloramphenicol.

    Product
    Pectinase Enzyme Blends, bulk, custom blended formulations identified as pectinase 500, pectinase 1000, Pectinase 350 Endo-pg/gm, PC Blend 14, Nut 14-500, pectinase 3500, gastro blend 0111, Digestive Blend 021894, enzyme complex 5763, pectinase 1750, pectinase 350, EC-CHPX…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0352-2014·2013-11-27

    Spacelabs recalls anesthesia workstation absorbers due to potential switch failure

    Spacelabs Healthcare is recalling CAS I/II Absorbers for Blease anesthesia workstations because the Bag-to-Vent switch may fail due to loose hardware.

    Product
    CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, and service kits part number 050-0659-00 and 050-0901-00. BleaseFocus…
    Category
    Medical Device
    Distribution
    Distributed nationwide