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.

43426–43450 of 50511

  • HighFDA (Devices)·Z-1539-2013·2013-06-19

    Abbott STAR S3 Excimer Laser System Recalled for Firing Risk

    Abbott Medical Optics is recalling STAR S3 Excimer Laser Systems due to an unlikely potential for inadvertent laser firing under specific conditions.

    Product
    STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1524-2013·2013-06-19

    Bard UltraClip breast tissue marker recall due to separation risk

    Bard Peripheral Vascular is recalling UltraClip breast tissue markers because the metal marker may separate from the needle before use.

    Product
    BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1512-2013·2013-06-19

    Purely American Recalls Minestrone Soup Mix for Missing Wheat Allergen Label

    Purely American, Inc. is recalling 413 bags of Mama Marino's Minestrone Soup Mix because the labels are missing the required wheat allergen declaration.

    Product
    MAMA MARINO'S MINESTRONE SOUP MIX 15 oz cello bag Contents: Assorted beans & barley, Enriched semolina flour***spray dried tomato, spinach and beet powders, water, dehydrated carrots, onions, peas, tomato flakes, celery flakes, bell peppers, parsley & spices***PURELY AMERICAN…
    Category
    Food
    Distribution
    20 states
  • HighCPSC·13740·2013-06-19

    Polaris Recalls 2011 Ranger RZR XP 900 Vehicles Due to Burn Hazard

    Polaris is recalling about 4,500 2011 Ranger RZR XP 900 off-highway vehicles because the firewall can overheat and melt, posing a burn risk.

    Product
    2011 Polaris Ranger RZR XP 900 recreational off-highway vehicles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1530-2013·2013-06-19

    Ethicon Recalls Echelon 60mm Endoscopic Linear Cutter Reloads

    Ethicon Endo-Surgery is voluntarily recalling Echelon 60mm endoscopic linear cutter reloads worldwide due to potential reload damage that could cause incomplete staple line formation.

    Product
    ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid. The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are sterile, single patient use instruments that simultaneously cut and staple tissue.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1527-2013·2013-06-19

    Bard UltraClip Breast Tissue Markers Recalled for Lack of Sterilization

    Bard Peripheral Vascular is recalling 315 UltraClip breast tissue markers that were distributed without completing the sterilization process.

    Product
    BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, Non-pyrogenic, Rx only; Bard Peripheral Vascular, Inc., 1625 West 3rd Street…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1511-2013·2013-06-19

    Purely American Seafood Chowder Mix Recalled for Missing Wheat Allergen Label

    Purely American, Inc. is recalling 15 oz bags of Long Island Baymen Seafood Chowder Mix because the labels are missing the required wheat allergen declaration.

    Product
    LONG ISLAND BAYMEN SEAFOOD CHOWDER MIX 15 oz cello bag Contents: All natural enriched semolina flour***spray dried tomato, spinach and beet powders, water, spices, dried carrots, garlic, black pepper, jalapeno peppers, bay leaf***PURELY AMERICAN 5991 Industrial Park Road…
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-1520-2013·2013-06-19

    DePuy Glenosphere Orientation Guide Recalled for Incorrect Etched Arrow Placement

    DePuy Orthopaedics is recalling Glenosphere orientation guides because an etched arrow is on the wrong side, which could lead to incorrect implant alignment.

    Product
    DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation guide is used to properly align the glenosphere.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13219·2013-06-18

    Idea Baby Bath Seats Recalled for Drowning Risk

    Chelsea & Scott is recalling Idea Baby Bath Seats because they can tip over, posing a drowning hazard to infants.

    Product
    Idea Baby Bath Seats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13217·2013-06-18

    BeBeLove Recalls Baby Bath Seats Due to Drowning Hazard

    BeBeLove is recalling about 5,600 E-Zee Bath Seats because they can tip over, posing a drowning risk to babies. No injuries have been reported.

    Product
    Baby Bath Seats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13737·2013-06-17

    Sam's Club Recalls Outdoor Seating Groups Due to Fall Hazard

    Sam's Club is recalling Metro and Montero outdoor seating groups because swivel bases can break, posing a fall hazard. No injuries have been reported.

    Product
    Metro 6-piece Outdoor Seating Group and Montero 4-piece Outdoor Seating Group
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13215·2013-06-13

    Stride Rite Recalls Girls' Sandals Due to Choking Hazard

    Stride Rite is recalling about 7,500 'Joanna' girl's sandals because the metal flower on top can detach, posing a choking hazard to children.

    Product
    Joanna Girl's Sandal
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1487-2013·2013-06-12

    Chemi-Source Casein Powder Recalled for Unlabeled Milk Allergen

    Chemi-Source Inc. is recalling 1,320 units of 100% Micellar Casein powder because the milk ingredient was not listed as an allergen.

    Product
    Casein - 100% Micellar Casein - Cookies & Cream¿2.02 LBS: Soy Lecithin,Casein/Caseinate,Wheat UPC 6-09492 72242-3
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1516-2013·2013-06-12

    American Optisurgical Recalls TX1 Tissue Removal System Consoles

    American Optisurgical is recalling 194 TX1 Tissue Removal System Consoles due to a defect in the overheating protection circuit that may cause the device to lose power during use.

    Product
    American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Food)·F-1493-2013·2013-06-12

    All Natural Gainer Chocolate Protein Powder Recalled for Undeclared Milk Allergen

    Chemi-Source Inc is recalling All Natural Gainer Chocolate protein powder because the milk ingredient was not listed on the label.

    Product
    All Natural Gainer - Chocolate¿3.3 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate, Cocoa UPC 6-09492 73004-6
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1506-2013·2013-06-12

    Alcon Recalls Constellation Pneumatic Handpieces Due to Tip Dislodgement Risk

    Alcon is removing 8,455 Constellation Pneumatic Handpieces from the market because forceps or scissors tips may dislodge if not attached according to instructions.

    Product
    The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1483-2013·2013-06-12

    Zimmer Air Dermatome Recalled for Broken Planetary Gear Teeth

    Zimmer Surgical Inc is recalling 84 units of the Zimmer Air Dermatome because broken planetary gear teeth may cause the device to fail during surgery.

    Product
    The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1498-2013·2013-06-12

    MRM All Natural Whey Recalled for Undeclared Milk Allergen

    Chemi-Source Inc. is recalling MRM All Natural Whey Dutch Chocolate products because the whey ingredient was not listed as milk, a major allergen.

    Product
    MRM All Natural Whey - Dutch Chocolate 2.02 lbs, 1.01 lbs; All Natural Whey 10pk/bx Dutch Chocolate: Whey Protein/Isolate Contains: Soy, Dairy, Cocoa, Nitrozyme UPC 6-09492 72004-7 (2.02 lbs) UPC 6-09492 72095-5 (10 pk) UPC 6-09492 72005-4(1.01 lbs)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1444-2013·2013-06-12

    I-Flow ON-Q Pain Relief System T-Block Needle/Catheter Tray Recall

    I-Flow LLC is voluntarily removing 450 units of the ON-Q Pain Relief System T-Block Needle/Catheter Tray because the devices may have malfunctioned.

    Product
    I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1496-2013·2013-06-12

    Fruit-N-Whey Protein Powder Recalled for Unlabeled Milk Allergen

    Chemi-Source Inc is recalling Fruit-N-Whey protein powder because the whey ingredient was not listed as a milk allergen, posing a risk to consumers with milk allergies.

    Product
    Fruit-N-Whey 2.03lbs and Fruit-N-Whey Mixed Berries 2.03 lbs: Whey Protein/Isolate, Soy Lecithin. Contains: Dairy, Benefruit Blend, Natural Berry Flavors UPC 6-09492 72065-8
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1502-2013·2013-06-12

    Sprouts Farmers Market Whey Protein Strawberry Recalled for Undeclared Milk Allergen

    Sprouts Farmers Market Whey Protein Strawberry is being recalled because the whey ingredient is not listed as milk, an allergen. Consumers with milk allergies are at risk of serious reactions.

    Product
    Sprouts Farmers Market Whey Protein Strawberry: 1 lbs, 2 lbs : Whey Protein/Isolate, Soy Lecithin UPC 6-46670 68122-6 (1 lbs) UPC 6-46670 68128-8 (2 lbs):
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1478-2013·2013-06-12

    Chemi-Source Whey Protein Recalled for Undeclared Milk Allergen

    Chemi-Source Inc is recalling All Natural Whey protein products because the milk ingredient was not listed on the label, posing a risk to consumers with milk allergies.

    Product
    All Natural Whey - Natural Flavor 1.89 LBS: Whey Protein Concentrate and Isolate, Casein/Caseinate, Nitrozyme UPC 6-09492 72000-9 :
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1508-2013·2013-06-12

    Cordis Recalls FLEXSTENT Stent Systems Due to Pouch Integrity Issues

    Cordis is recalling 784 FLEXSTENT stent systems because holes or tears can form in the protective pouches, potentially compromising the device.

    Product
    FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
    Category
    Medical Device
    Distribution
    Distributed nationwide