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.

36926–36950 of 50506

  • HighFDA (Devices)·Z-0471-2016·2015-12-30

    Biomet Black Mamba Suture Passer Recalled for Weld Defect

    Biomet is recalling 50 Black Mamba Suture Passers because a weld defect may cause the instrument's jaw to fail to actuate properly.

    Product
    Black Mamba Suture Passer
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-0423-2016·2015-12-30

    Aesculap Flexible Bone Awl Recalled for Potential Shaft Breakage

    Aesculap, Inc. is recalling 41 Flexible Bone Awls (SJ607R) because the flexible shaft may break during surgery, posing a risk of fragments remaining in patients.

    Product
    Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG: These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0456-2016·2015-12-30

    BD Vacutainer K2 EDTA Blood Collection Tubes Recalled for Stopper Defect

    Becton Dickinson is recalling 4.8 million blood collection tubes because stoppers may not be fully inserted, posing a risk of blood exposure.

    Product
    BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0458-2016·2015-12-30

    Siemens Reagent Management System Recalled for Electrical Hazard

    Siemens is recalling 106 Reagent Management System units because a missing safety cover exposes an electrical hazard on the compressor.

    Product
    Reagent Management System (RMS) Dimension EXL with LM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0453-2016·2015-12-30

    Zimmer Universal Power System Handpieces Recalled for Malfunction

    Zimmer, Inc. is recalling 89 Universal Power System handpieces that may start by themselves when the power source is connected.

    Product
    Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece. Rx only Made in Switzerland
    Category
    Medical Device
    Distribution
    32 states
  • HighCPSC·16068·2015-12-30

    Origin8 Recalls Folding Bicycles Due to Frame Breakage and Fall Hazard

    Origin8 is recalling F1, F3, and F7 folding bicycles because the frame welds can crack or fail, posing a fall hazard. Consumers should stop using the bikes and return them for a free replacement.

    Product
    Origin8 folding bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0459-2016·2015-12-30

    Siemens Reagent Management System Recalled for Electrical Hazard

    Siemens is recalling four Reagent Management System units because a missing safety cover exposes an electrical termination block, creating a shock hazard.

    Product
    Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0455-2016·2015-12-30

    CareFusion Recalls Alaris EtCO2 Module 8300 Due to Calibration Error

    CareFusion is recalling 157 Alaris EtCO2 Module 8300 units because they may have been tested with high CO2 concentrations, potentially causing incorrect measurements.

    Product
    Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0467-2016·2015-12-30

    Siemens MAGNETOM MRI Systems Recalled for Quench Line Installation Errors

    Siemens is recalling MAGNETOM MRI systems due to potential quench line installation errors that could cause oxygen displacement or cold burns.

    Product
    MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0419-2016·2015-12-30

    Fat Bastard Gourmet Chick Dip Recalled for Undeclared Honey

    The Family Jewels LLC is recalling Fat Bastard Gourmet Chick Dip because it contains undeclared honey, a major food allergen.

    Product
    Fat Bastard Gourmet Chick Dip Honey Roasted Hickory Smoke Sassy Barbecue, Net Wt. 12 Fl. Oz. (375 ml), UPC 8 91929 12702 8. The responsible firm name on the label is The Family Jewels, Montreal, MO 65591.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0474-2016·2015-12-30

    Becton Dickinson Recalls Enterococcus Screen Agar QUAD Plates

    Becton Dickinson is recalling 770 units of Enterococcus Screen Agar QUAD Plates due to potential breakthrough growth of Enterococcus faecalis near the end of shelf life.

    Product
    Enterococcus Screen Agar QUAD Plate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0424-2016·2015-12-30

    Reser's Potato Salad Recalled for Possible Listeria Contamination

    Reser's Fine Foods is recalling Winn Dixie Old Fashioned Potato Salad due to possible Listeria monocytogenes contamination.

    Product
    Winn Dixie Old Fashioned Potato Salad, Net Wt. 16oz (1 LB) 454g.
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·15V886000·2015-12-30

    Micro Bird Recalls 2015 School Buses for Stop Arm Decal Issue

    Micro Bird is recalling 66 model year 2015 school buses because the stop arm decal may peel off, reducing visibility and increasing crash risk.

    Product
    MICRO BIRD — MICRO BIRD MB II SCHOOL BUS, G5 SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0551-2016·2015-12-30

    Terumo Recalls Winged Infusion Sets Due to Improper Bonding

    Terumo Medical Corp is recalling 80,500 units of Surflo Winged Infusion Sets distributed in California due to potential improper bonding between the tube and luer.

    Product
    Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0445-2016·2015-12-30

    CareFusion Recalls Alaris Pump SmartSite Infusion Sets Due to Leakage Risk

    CareFusion is recalling Alaris Pump SmartSite Infusion Sets because disconnection and leakage may occur during infusion.

    Product
    Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16718·2015-12-30

    KTM Recalls 2015-2016 Freeride 250R Motorcycles Due to Fuel Leak Fire Risk

    KTM North America is recalling about 550 model year 2015 and 2016 Freeride 250R off-road motorcycles because fuel can escape from the tank breather assembly, posing a fire and injury risk.

    Product
    KTM Competition/Closed Course Off-Road Motorcycles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0452-2016·2015-12-30

    Zimmer Universal Power System Handpieces Recalled for Malfunction

    Zimmer, Inc. is recalling 87 Universal Power System handpieces because a malfunction could cause them to start unexpectedly when connected to a power source.

    Product
    Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. Rx only Made in Switzerland
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0450-2016·2015-12-30

    Biomet Recalls A.L.P.S. 4.0mm Cancellous Locking Screws Due to Thread Defect

    Biomet is recalling A.L.P.S. 4.0mm Cancellous Locking Screws because a single-lead thread design may cause screws to sit proud or back out, potentially requiring revision surgery.

    Product
    A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones.
    Category
    Medical Device
    Distribution
    51 states
  • HighNHTSA·15V880000·2015-12-28

    Tiffin Motorhomes Recall 2007-2015 Models Due to Unstable Entry Steps

    Tiffin is recalling 2007-2015 motorhomes because a bolt on the electric steps may fracture, causing the steps to become unstable and increasing the risk of injury.

    Product
    TIFFIN — TIFFIN ALLEGRO, ALLEGRO BAY, BAY, PHAETON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0410-2016·2015-12-23

    Kerry Foods Recalls Cinnamon Topical G4205 Due to Metal Contamination

    Kerry Foods is voluntarily recalling Cinnamon Topical G4205 because it may contain metal. The recall covers 176,596 lbs distributed across 19 states.

    Product
    Kerry, Cinnamon Topical G4205, SS189, G4205.49, , UPC:Inner: 766818313403; Outer: 10766818313400, NET WT: 50 lb (22.68 kg).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-0437-2016·2015-12-23

    Medtronic MiniMed 620G Insulin Pump Recall for Motor Malfunction

    Medtronic is recalling 53 MiniMed 620G insulin pumps because a motor malfunction may stop insulin delivery. The issue involves a ball bearing assembly.

    Product
    MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. In addition, the pump…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0414-2016·2015-12-23

    GE Healthcare Optima IGS 320 Recall for Loss of Displayed Imaging

    GE Medical Systems is recalling 45 Optima IGS 320 systems due to a potential safety issue involving non-recoverable loss of displayed imaging.

    Product
    GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0402-2016·2015-12-23

    Kerry Foods Recalls Black Sanding Sugar Due to Metal Contamination

    Kerry Foods is voluntarily recalling Sprinkle King Black Sanding Sugar because it may contain metal. The product was distributed to 19 states.

    Product
    Sprinkle King, Black Sanding Sugar, QBLK413.L32, UPC: Inner: 00766818310006 ; Outer: 10766818310003, NET WT: 32 lb (14.51 kg).
    Category
    Food
    Distribution
    19 states
  • HighNHTSA·15V870000·2015-12-23

    Navistar Recalls IC Bus Transit Models Due to Wheelchair Lift Defect

    Navistar is recalling certain 2007-2015 IC Bus transit models because wheelchair lift bearings may move out of position, causing the platform to fall.

    Product
    IC BUS — IC BUS CE, FECB, FE, RE
    Category
    Vehicle
    Distribution
    Distributed nationwide