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.

42326–42350 of 50511

  • HighFDA (Devices)·Z-0451-2014·2013-12-11

    Abbott i-STAT PT/INR Cartridges Recalled for Potential INR Errors

    Abbott Point of Care Inc. is recalling i-STAT PT/INR cartridges because they may display incorrectly elevated INR results.

    Product
    Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0441-2014·2013-12-11

    Boston Scientific Recalls Navigator HD Ureteral Access Sheath Sets

    Boston Scientific is recalling Navigator HD Ureteral Access Sheath Sets because the dilator tip may separate from the body.

    Product
    Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-094-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Estradiol Pellets Due to Adverse Reactions

    Main Street Family Pharmacy is recalling Estradiol Pellets 31mg after receiving reports of skin abscesses linked to a different compounded product.

    Product
    Estradiol Pellets 31mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0675-2014·2013-12-11

    Garden-Fresh Foods Recalls Ready-to-Eat Salads and Dips for Listeria Risk

    Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products because they may be contaminated with Listeria monocytogenes.

    Product
    Grandpas Fresh Salsa, Product Code 5912, 1/5 lb; Grandpas Fresh Salsa, Product Code 5913, 19 4/5 lb; Roundy's Fresh Salsa Product Code 0 11596 06117 7, 12/15 oz
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0700-2014·2013-12-11

    Simply D'Lish Sea Salt Chocolate Chip Cookies Recalled for Undeclared Milk

    Simply D'Lish is recalling Sea Salt Chocolate Chip Cookies because the milk allergen was not declared on the label, despite butter being listed as an ingredient.

    Product
    Sea Salt Chocolate Chip Cookie, 3-oz (85g), individually wrapped in plastic and labeled in part: Manufactured for Simply D'lish, LLC.; Aurora, IL 60504; www.simplydlish.biz
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-325-2014·2013-12-11

    Badger Kids Sunscreen Recalled for Microbial Contamination

    W.S. Badger Company is recalling specific lots of Badger Kids Sunscreen Lotion due to microbial contamination. The product was distributed in the US, Canada, and several other countries.

    Product
    Badger Kids Broad Spectrum SPF30 Zinc Oxide Sunscreen Lotion Tangerine & Vanilla, 4 fl. oz.. Tube, UPC Code: 634084490145 (US), UPC code: 634084490169 (Canada)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0532-2014·2013-12-11

    Garden-Fresh Recalls Ready-to-Eat Salads and Dips Due to Listeria Risk

    Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products because they may be contaminated with Listeria monocytogenes.

    Product
    Garden-Fresh Whole Grain Penne With Spinach , Tomato & Feta, Product Code 0 11596 52063 6, 1/5 lb
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-0453-2014·2013-12-11

    Sunrise Zippie Voyage Stroller Recalled for Potential Seat Dislodgement

    Sunrise Medical is recalling Zippie Voyage strollers because a plastic latch may deform, allowing the seat to dislodge and causing the occupant to slide out.

    Product
    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0698-2014·2013-12-11

    Simply D'Lish Vermont Maple Oat Cookies Recalled for Undeclared Milk Allergen

    Simply D'Lish is recalling Vermont Maple Oat Cookies because the milk allergen was not declared on the label, despite butter being listed as an ingredient.

    Product
    Vermont Maple Oat Cookie, 3-oz (85g), individually wrapped in plastic and labeled in part: Manufactured for Simply D'lish, LLC.; Aurora, IL 60504; www.simplydlish.biz
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0699-2014·2013-12-11

    Simply D'Lish Peanut Butter Chocolate Chip Cookies Recalled for Undeclared Milk

    Simply D'Lish is recalling peanut butter chocolate chip cookies because the milk allergen was not declared on the label, despite butter being listed as an ingredient.

    Product
    Peanut Butter Chocolate Chip Cookie,3-oz (85g), individually wrapped in plastic and labeled in part: Manufactured for Simply D'lish, LLC.; Aurora, IL 60504; www.simplydlish.biz
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0442-2014·2013-12-11

    Boston Scientific Recalls Navigator HD Ureteral Access Sheath Sets

    Boston Scientific is recalling 449 units of Navigator HD Ureteral Access Sheath Sets because the dilator tip may separate from the body.

    Product
    Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14049·2013-12-11

    Solowave Recalls Tornado Tube Slides Due to Laceration Hazard

    Solowave is recalling Tornado brand home playground tube slides because plastic port holes can break and cut children. About 20,700 units were sold in the U.S. and Canada.

    Product
    Tornado brand home playground tube slides with port holes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0697-2014·2013-12-11

    Simply D'Lish Recalls Key Lime Sugar Cookies Due to Undeclared Milk Allergen

    Simply D'Lish, LLC is recalling Key Lime Sugar Cookies because the milk allergen was not declared on the label, despite butter being listed as an ingredient.

    Product
    Key Lime Sugar Cookie, 3-oz (85g), individually wrapped in plastic and labeled in part: Manufactured for Simply D'lish, LLC.; Aurora, IL 60504; www.simplydlish.biz
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0696-2014·2013-12-11

    Simply D'Lish Caramel Sea Salt Chocolate Chip Cookies Recalled for Undeclared Milk

    Simply D'Lish is recalling Caramel Sea Salt Chocolate Chip Cookies because the milk allergen was not declared on the label.

    Product
    Caramel Sea Salt Chocolate Chip Cookie, 3-oz (85g), individually wrapped in plastic wrapper and labeled in part: Manufactured for Simply D'lish, LLC.; Aurora, IL 60504; www.simplydlish.biz
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0455-2014·2013-12-11

    Synthes Zero-P VA Implant Recalled for Potential Screw Back-Out Risk

    Synthes USA is recalling specific Zero-P VA implants because a screw could back out if the blocking mechanism is not visually confirmed to cover the screw head.

    Product
    Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0436-2014·2013-12-11

    Intuitive Surgical Recalls da Vinci Patient Side Manipulator Assemblies

    Intuitive Surgical is recalling 1,386 da Vinci Patient Side Manipulator assemblies due to friction that can cause instrument motion to stall and catch up.

    Product
    Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical System; da Vinci SI Surgical System da Vinci Si-e Surgical System; Manufactured by Intuitive Surgical Sunnyvale, CA 94086. The Intuitive Surgical Endoscopic Instrument Control System…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0454-2014·2013-12-11

    GE Centricity Web Software Recalled for Patient Safety Concerns

    GE Healthcare is recalling Centricity Web software due to an issue with rejected images that may impact patient safety.

    Product
    The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the clinical review of medical images and reports. The…
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0440-2014·2013-12-11

    Boston Scientific Recalls Navigator HD Ureteral Access Sheath Sets

    Boston Scientific is recalling 274 units of Navigator HD Ureteral Access Sheath Sets because the dilator tip may separate from the body.

    Product
    Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V615000·2013-12-11

    GM Recalls 2012-2013 Silverado and Sierra HD Diesel Trucks

    General Motors is recalling 2012-2013 Chevrolet Silverado HD and GMC Sierra HD diesel trucks because a fuel transfer pump malfunction could cause the vehicle to stall unexpectedly.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO, SIERRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0433-2014·2013-12-11

    Siemens syngo Lab Data Manager Software Recall for Auto-verification Failures

    Siemens Healthcare Diagnostics is recalling syngo Lab Data Manager software versions VA11B and VA12A because the system may release results that require manual review or delay result transmission.

    Product
    syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0432-2014·2013-12-11

    Olympus Recalls Thunderbeat Surgical Instruments Due to Component Damage

    Olympus America Inc. is recalling Thunderbeat surgical instruments because they may crack, break, or deform during use.

    Product
    TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14045·2013-12-10

    Exmark Recalls Commercial Walk-Behind Mowers Due to Blade Injury Hazard

    Exmark is recalling 2013 Commercial 30-inch Walk-Behind Mowers because the blade can break and injure users. Consumers should stop using the mowers and contact Exmark for a free repair.

    Product
    Commercial Walk-Behind Mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide