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.

42801–42825 of 50511

  • HighFDA (Devices)·Z-2231-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Ultra HA Suture Anchors Due to Sterile Breach

    Smith & Nephew is recalling TWINFIX Ultra HA 5.5 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1538-2013·2013-09-25

    Laserworld Laser Light Show Projectors Recalled for Missing Safety Labels

    Laserworld USA Inc. is recalling RGB and Piko Nano RGB laser light show projectors due to missing laser safety warnings and incomplete user information.

    Product
    Laserworld RGB & Piko Nano RGB Models All models are laser light show projectors, and will be used as such.
    Category
    Consumer Product
    Distribution
    5 states
  • HighFDA (Devices)·Z-2217-2013·2013-09-25

    Smith & Nephew Recalls Bioraptor Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling 1,735 Bioraptor 2.9 mm suture anchors because pinholes in the primary pouches may breach the sterile barrier.

    Product
    BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number: 72200783 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2245-2013·2013-09-25

    Instrumentation Laboratory Recalls ACL TOP 700 Analyzers for Carryover Issue

    Instrumentation Laboratory is recalling 311 ACL TOP 700 analyzers due to a potential carryover issue that may cause shortened APTT clotting times.

    Product
    ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems…
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Food)·F-1884-2013·2013-09-25

    Tasty Bake Frozen Dough Balls Recalled for Cryptosporidium Contamination Risk

    Tasty Bake Inc. is recalling frozen dough balls processed with Baker City, Oregon water due to potential Cryptosporidium contamination following a local boil water notice.

    Product
    Frozen dough balls are sold under brand name Winco or Tasty Bake: Item # 04018 is 17 oz wheat dough ball, Winco brand, individually wrapped in plastic bag with label for retail use, UPC 0 31693 04018 9; Item # 00518 is 17 oz white dough ball, Winco brand, individually…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2233-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Ultra Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling TWINFIX Ultra suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 72202602 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2199-2013·2013-09-25

    Tornier Recalls Aequalis Reversed II and Fracture Impactors

    Tornier is voluntarily recalling Aequalis Reversed II and Fracture Impactors because the tip may separate during surgery.

    Product
    AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are MWD21, MWD023, MWD024 and MWD025.…
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Food)·F-1899-2013·2013-09-25

    Jean's Cake Recalls Coffee Cake for Undeclared Food Dyes

    Jean's Cake is recalling Coffee Cake: queso crema (creme cheese) due to undeclared Yellow #5 and Yellow #6 dyes.

    Product
    Coffee Cake: queso crema (creme cheese)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2225-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1901-2013·2013-09-25

    Jean's Cake Recalls Coffee Cake Due to Undeclared Allergens

    Jean's Cake is recalling Coffee Cake: queso/manzana (cheese/apple) because it contains undeclared Yellow #5 and Yellow #6.

    Product
    Coffee Cake: queso/manzana (cheese/apple)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2221-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2232-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Ultra HA Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling 708 TWINFIX Ultra HA suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1896-2013·2013-09-25

    General Mills Recalls Pillsbury Cinnamon Rolls Due to Plastic Fragments

    General Mills is recalling specific cans of Pillsbury Cinnamon Rolls with Icing because the dough may contain fragments from a broken piece of plastic on the production line.

    Product
    Pills bury Cinnamon Rolls with Icing, CINNA BON, USPC 1800000501, 1800052230, 12.4 oz and 2-pack USPC 1800045675,2- 12.4 oz (351 G) CANS, NET WT 24.8 OZ (1 LB 8.8 OZ 703 G.
    Category
    Food
    Distribution
    43 states
  • HighFDA (Devices)·Z-2230-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling TWINFIX Ultra HA 4.5 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202624 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2237-2013·2013-09-25

    Smith & Nephew Recalls RAPTORMITE Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling RAPTORMITE 3.7 mm PLLA suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number: 72201805 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2240-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Ultra Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling TWINFIX Ultra suture anchors because pinholes in the primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202620 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2201-2013·2013-09-25

    GE Healthcare Recalls CARESCAPE Monitor B850 for Alarm Priority Issue

    GE Healthcare is recalling 636 CARESCAPE Monitor B850 units due to a software issue that may cause incorrect alarm priorities when managed via the iCentral network.

    Product
    GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V462000·2013-09-23

    Cargo Craft Recalls 2006-2013 Trailers Due to Door Lock Jamming Risk

    Cargo Craft is recalling 2006-2013 cargo trailers because a door lock defect may jam the deadbolt, potentially trapping occupants inside the vehicle.

    Product
    CARGO CRAFT — CARGO CRAFT CARGO TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V459000·2013-09-20

    New Flyer Recalls 2012 XN40 Buses with Defective Bicycle Racks

    New Flyer is recalling 2012 XN40 transit buses because cracks in certain bicycle racks may cause parts to fall off, creating a road hazard.

    Product
    NEW FLYER — NEW FLYER XN40
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13751·2013-09-19

    The Land of Nod Recalls Iron Sleigh, Petal, and Picket Bed Frames

    The Land of Nod is recalling specific iron bed frames due to an entrapment hazard for young children. One incident of entrapment was reported without injury.

    Product
    Iron Sleigh, Petal and Picket bed frames
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13289·2013-09-19

    Shimano Recalls Disc Brake Calipers Due to Collision Hazard

    Shimano American is recalling approximately 6,600 disc brake calipers in the U.S. because they can fail, posing a collision hazard. No injuries have been reported.

    Product
    Disc brake calipers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2194-2013·2013-09-18

    Ormco Recalls Vector TAS 8mm Orthodontic Screws Due to Manufacturing Defect

    Ormco is voluntarily recalling one lot of Vector TAS 8mm orthodontic screws because some were machined undersized, which may cause the screws to break during use.

    Product
    Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm Screw is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and removed after…
    Category
    Medical Device
    Distribution
    Distributed nationwide