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.

35976–36000 of 50504

  • HighFDA (Food)·F-1091-2016·2016-04-27

    Aldi Season's Choice Prince Edward Medley Recalled for Listeria

    Camericam International Inc. is recalling Aldi Season's Choice Prince Edward Medley because a limited number of products tested positive for Listeria monocytogenes.

    Product
    Seasons Choice Prince Edward Medley Net Wt. 16 oz. Distributed by: Aldi Inc. Batavia, IL 60510 Product of Netherlands UPC will be entered.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1514-2016·2016-04-27

    Ossur Lil Angel Vest Recalled for Potential Plastic Strap Fracture

    Ossur H / F is recalling Lil Angel Vest P3 Lambswool units because the plastic stabilizer strap may fracture. The recall covers 435 units distributed in the US and Hong Kong.

    Product
    Ossur Lil Angel Vest P3 Lambswool. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1537-2016·2016-04-27

    Smith & Nephew Recalls TC-PLUS Knee Prosthesis Due to Dimensional Deviation

    Smith & Nephew is recalling two units of the TC-PLUS Primary Fixed Tibial Component due to a dimensional deviation that may prevent the polyethylene insert from seating properly during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R, REF 12 000 002, S&N 7500257, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1499-2016·2016-04-27

    Leica Surgical Microscopes Recalled for Potential Overheating and Smoke

    Leica Microsystems is recalling 381 M525 and M720 surgical microscopes because an electronic component may overheat, causing smoke and smell.

    Product
    Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device. Intended for improving the visibility of objects through magnification and illumination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1525-2016·2016-04-27

    Coloplast Recalls Pediatric Catheters Due to Missing Eyelets

    Coloplast is voluntarily recalling a single lot of Self-Cath Pediatric Catheters because some units have missing eyelets, which can cause catheter malfunction.

    Product
    Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306. Product Usage: The Self-Cath intermittent urinary catheter discussed in this document is a pediatric size CH06 French catheter. The catheter is indicated for use by patients with chronic urine…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1541-2016·2016-04-27

    Smith & Nephew Recalls TC-Plus Tibial Knee Prosthesis Components

    Smith & Nephew is recalling four units of TC-Plus tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 0011, S&N 7500266, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·16151·2016-04-26

    Ryobi Brushless Snow Blowers Recalled for Fire and Burn Hazards

    One World Technologies is recalling Ryobi 40-Volt Brushless Snow Blowers sold at Home Depot due to overheating risks that can cause fires and burns.

    Product
    Ryobi Brushless Snow Blowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V247000·2016-04-26

    Ford Recalls Taurus, Flex, and MKS for Air Bag Defect

    Ford is recalling specific 2008-2012 Taurus, Flex, Taurus X, Sable, and MKS vehicles because the driver's frontal air bag may inflate improperly during a crash.

    Product
    FORD — FORD, LINCOLN, MERCURY TAURUS X, FLEX, MKS, TAURUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16153·2016-04-26

    Stile Products Recalls Tern Folding Bicycles Due to Frame Hinge Crack Hazard

    Stile Products is expanding a recall of specific Tern folding bicycles because the frame hinge can crack, posing a fall hazard. Consumers should stop riding these bikes and contact the company for a free frame replacement.

    Product
    Tern folding bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16E037000·2016-04-22

    Freedman Seating Recalls School Bus Seats Due to Bolt Failure

    Freedman Seating is recalling specific school bus seats manufactured in January 2016 because bolt failure may cause the seat to separate from the base frame during a crash.

    Product
    SEATS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V236000·2016-04-22

    Toyota and Scion vehicles recalled for incorrect load capacity labels

    NHTSA is recalling 2016 Toyota and Scion vehicles because the load carrying capacity label may be incorrect, potentially leading to vehicle overload.

    Product
    TOYOTA — TOYOTA, SCION 4RUNNER, LAND CRUISER, YARIS, IM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1429-2016·2016-04-20

    Customed Dressing Change Tray Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 550 Dressing Change Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001538 DRESSING CHANGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1064-2016·2016-04-20

    Chicken of the Sea Canned Tuna Recalled for Potential Undercooking

    Tri-Union Seafoods is recalling Chicken of the Sea canned tuna due to an equipment malfunction that may have caused the product to be undercooked.

    Product
    Chicken of the Sea 5 Oz. Canned Chunk Light Tuna in Oil, 48 cans per case, UPC code is 0 4800000195 5
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1440-2016·2016-04-20

    Customed Liver and Pancreas Surgery Kits Recalled for Sterilization Issues

    Customed, Inc. is recalling 20 liver and pancreas surgery kits due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001966 LIVER & PANCREAS SURGERY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1464-2016·2016-04-20

    Customed Obstetrical Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 304 Obstetrical Surgical Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002940 OBSTETRICAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1459-2016·2016-04-20

    Customed Urethral Catheter Tray Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 2,450 Urethral Catheter Trays (14FR) distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900278 URETHRAL CATHETER TRAY 14FR Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1415-2016·2016-04-20

    Customed Wound Manage II Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling Wound Manage II kits due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001198 WOUND MANAGE II Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1479-2016·2016-04-20

    Customed Lap-Cholecystectomy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 144 units of Lap-Cholecystectomy Surgical Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900576A LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1427-2016·2016-04-20

    Customed Laparoscopy Surgical Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 12 units of D&C Laparoscopy Surgical Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001496 D&C LAPAROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1443-2016·2016-04-20

    Customed Lithotomy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 150 Lithotomy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002167 LITHOTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state