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.

42776–42800 of 50511

  • HighFDA (Devices)·Z-2220-2013·2013-09-25

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

    Smith & Nephew is recalling OSTEORAPTOR 2.3 mm suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part Number: 72201993 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2247-2013·2013-09-25

    Instrumentation Laboratory Recalls ACL TOP 700 LAS Analyzers for Carryover Issue

    Instrumentation Laboratory is recalling 56 ACL TOP 700 LAS analyzers due to a potential carryover issue that can cause shortened APTT clotting times.

    Product
    ACL TOP 700 LAS; PN 0000280030 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-1900-2013·2013-09-25

    Jean's Cake Recalls Coffee Cake Due to Undeclared Allergens

    Jean's Cake is recalling Coffee Cake: queso/fresa because it contains undeclared Yellow #5 and Yellow #6. The product was distributed only in Puerto Rico.

    Product
    Coffee Cake: queso/fresa (cheese/strawberry)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2257-2013·2013-09-25

    GE Healthcare Recalls Seno Advantage Workstations Due to Patient Mismatch Risk

    GE Healthcare is recalling 179 Seno Advantage workstations because a software issue may cause patient mismatch without a warning message, potentially impacting patient safety.

    Product
    GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 5342425-2, 5342425-3, 5342425-4, 5342425-5. Seno Advantage is a medical image review station that allows easy selection, processing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1895-2013·2013-09-25

    American Yeast Recalls Bulk Liquid Yeast Cream Due to Salmonella Contamination

    American Yeast Corporation is recalling bulk liquid yeast cream distributed to Maryland, Connecticut, Pennsylvania, and New York because it is contaminated with Salmonella.

    Product
    Liquid Yeast Cream, Bulk, in tanker truck quantities, refrigerated 33F-45F
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2229-2013·2013-09-25

    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, White / Blue; Part Number: 72202597 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2214-2013·2013-09-25

    Ebi Recalls Cypher MIS Screw System Due to Screw Head Splay

    Ebi, LLC is recalling 427 units of the Cypher MIS Screw System because several complaints reported screw head splay.

    Product
    Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1898-2013·2013-09-25

    Jean's Cake Recalls Coffee Cake for Undeclared Allergens

    Jean's Cake is recalling 550 units of coffee cake in Puerto Rico due to undeclared Yellow #5 and Yellow #6.

    Product
    Coffee Cake: queso/guava (cheese/guava)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2246-2013·2013-09-25

    Instrumentation Laboratory Recalls ACL TOP CTS Analyzers Due to Carryover Issue

    Instrumentation Laboratory is recalling 486 ACL TOP CTS analyzers because a potential carryover issue may cause shortened APTT clotting times.

    Product
    ACL TOP CTS; PN 0000280020 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 (Devices)·Z-2219-2013·2013-09-25

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

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

    Product
    BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2252-2013·2013-09-25

    Churchill Medical Systems Recalls Central Dressing Change Kits

    Churchill Medical Systems is recalling 3,040 Central Dressing Change Kits because microbore tubing may disconnect from male luers on the extension sets.

    Product
    Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves W/Wallet, Powderfree 1 Face Mask 1 Polylined Drape, 13" X 18" 1 ChloraPrep***, 3ml Applicator W/Insert 1 Pkg. Alcohol Swabsticks (3/Pkg.) 1 14" Extension Set…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2222-2013·2013-09-25

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

    Smith & Nephew is recalling OSTEORAPTOR 2.3 mm suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2236-2013·2013-09-25

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

    Smith & Nephew is recalling 1,643 TWINFIX Ultra suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1897-2013·2013-09-25

    Combs Produce Recalls Round Fresh Tomatoes Due to E. coli Risk

    Combs Produce is recalling 8,075 lbs of Round Fresh Tomatoes sold in 20-lb bulk boxes due to potential E. coli O157:H7 contamination.

    Product
    Round Fresh Tomatoes sold in bulk boxes, 20 lbs
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2210-2013·2013-09-25

    Philips Brilliance CT Scanners Recalled for Footswitch Cover Defect

    Philips is recalling Brilliance CT scanners because the footswitch cover may impinge on the footswitch, causing the patient support to move unexpectedly.

    Product
    Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143. Intended to produce cross-sectional images of the body by computer reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2013·2013-09-25

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

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

    Product
    TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202616 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2248-2013·2013-09-25

    Instrumentation Laboratory ACL TOP 700 CTS Analyzer Recall for Carryover Issue

    Instrumentation Laboratory is recalling 185 ACL TOP 700 CTS analyzers due to a potential carryover issue that may cause shortened APTT clotting times.

    Product
    ACL TOP 700 CTS; PN 0000280050 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 (Devices)·Z-2238-2013·2013-09-25

    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, posing a risk of infection.

    Product
    TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID") with Needles; Part Number: 72202612 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2235-2013·2013-09-25

    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 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part Number: 72202608 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2213-2013·2013-09-25

    Rauland-Borg Recalls Responder 5 Nurse Call Systems Due to Counterfeit Parts

    Rauland-Borg is recalling Responder 5 nurse call systems because counterfeit electronic components may cause the devices to lose communication functionality.

    Product
    Responder 5 is a nurse call communication system that connects patients with staff in a hospital. The nurse call system also connects team members and departments from radiology, physical therapy, transport, environmental services and more. Responder 5 is used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2215-2013·2013-09-25

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

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

    Product
    BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2243-2013·2013-09-25

    Synthes Cannulated Distal Femoral Nail Recalled Due to Prior Recall Scope

    Synthes USA is recalling one unit of a Cannulated Distal Femoral Nail because it was distributed despite being within the scope of a previous recall.

    Product
    Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.
    Category
    Medical Device
    Distribution
    1 state
  • HighCPSC·13291·2013-09-25

    BBQ Ant Votive Candle Holders Recalled for Fire and Burn Hazards

    Cracker Barrel is recalling BBQ Ant Votive Candle Holders because the decorative arms can break, causing candles to tip over and create fire or burn risks.

    Product
    BBQ Ant Votive Candle Holders
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2216-2013·2013-09-25

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

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

    Product
    BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 72200774 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide