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.

38026–38050 of 50506

  • HighFDA (Devices)·Z-2261-2015·2015-08-05

    Otto Bock Recalls Pheon 3R62 Polycentric Prosthetic Knee Joints

    Otto Bock Healthcare GmbH is voluntarily recalling 3R62 Pheon prosthetic knee joints because the locking function may fail, potentially causing a fall.

    Product
    Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V489000·2015-08-05

    Felling Recalls 2016 FT-6T Trailers Due to Tire Fender Rubbing

    Felling Trailers is recalling 92 model year 2016 FT-6T tilting trailers because improper fender placement may cause tires to rub, potentially leading to tire failure and a crash.

    Product
    FELLING — FELLING FT-6T
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V491000·2015-08-05

    DRV Suites Recalls Fifth Wheel Travel Trailers for Reflector Placement

    DRV Suites is recalling specific fifth wheel travel trailers because front side reflex reflectors are located above the maximum height of 60 inches, failing to comply with FMVSS 108.

    Product
    DRV — DRV ELITE SUITES ALL, ESTATES ALL, FULL HOUSE, TRADITION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2305-2015·2015-08-05

    Anspach G1 Dissection Tools Recalled Due to Inconsistent Shaft Exposure Labeling

    The Anspach Effort, Inc. is recalling 70 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure than specified.

    Product
    ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure; REF S-3SDC-22-G1. Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2310-2015·2015-08-05

    Anspach Diamond Ball Dissection Tools Recalled for Inconsistent Shaft Exposure

    The Anspach Effort, Inc. is recalling 70 Anspach 5MM Diamond Ball dissection tools because the shaft exposure may be greater than labeled when used with certain attachments.

    Product
    ANSPACH - 5MM Diamond Ball, 2MM Shaft Exposure; REF S-5D-2-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2057-2015·2015-08-05

    Hamilton-G5 Ventilators Recalled for Display Freeze Issue

    Hamilton Medical is recalling 248 Hamilton-G5 ventilators because the display can freeze, preventing users from operating the device while ventilation continues.

    Product
    Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2268-2015·2015-08-05

    OxiMax N-560 Pulse Oximeters Recalled for Display Segment Defects

    The FDA is recalling OxiMax N-560 Pulse Oximeters because missing display segments may cause users to misinterpret oxygen saturation and pulse rate data.

    Product
    OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2267-2015·2015-08-05

    OxiMax N-65 Pulse Oximeters Recalled for Display Segment Defects

    FDA is recalling OxiMax N-65 handheld pulse oximeters because missing display segments may cause users to misinterpret oxygen saturation and pulse rate data.

    Product
    OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2270-2015·2015-08-05

    Prism Medical P-600 Portable Ceiling Lift Recalled for Sling Attachment Risk

    Prism Medical is recalling 409 P-600 Portable Ceiling Lifts because sling loops may not stay attached to the carry bar hooks.

    Product
    Prism Medical P-600 Portable Ceiling Lift; PN 303090. Patient lift with weight specification of 600 lbs (273 kg). Product Usage: The P-600 lift is a lifting aid used by health care professionals and those providing care in the home to lift, position, and transfer clients…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2269-2015·2015-08-05

    Prism Medical P-440 Portable Ceiling Lift Recalled for Sling Attachment Risk

    Prism Medical is recalling P-440 Portable Ceiling Lifts because sling loops may not stay attached to the carry bar hooks.

    Product
    Prism Medical P-440 Portable Ceiling Lift; PN 303070 and 303070R (refurbished); Patient lift with weight specification of 440 lbs (200 kg). Product Usage: The P-440 lift is a lifting aid used by health care professionals and those providing care in the home to lift…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2262-2015·2015-08-05

    Encore Medical Recalls Foundation Knee System Cut Blocks Due to Marking Error

    Encore Medical is recalling 10 units of Foundation Knee System cut blocks because markings are mis-oriented, which could lead to improper surgical cuts.

    Product
    FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
    Category
    Medical Device
    Distribution
    2 states
  • HighCPSC·15207·2015-08-05

    MZB Recalls Children's Watches Due to Risk of Skin Irritation

    MZB is recalling about 1.9 million children's watches because the case-back can detach, exposing the interior to water and causing skin irritation or chemical burns.

    Product
    MZB Children's "Light Up" Watches
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2903-2015·2015-08-05

    Dairy Farmers of America Recalls Fat-Free Swiss Cheese Due to Plastic Film

    Dairy Farmers of America is recalling specific fat-free Swiss cheese products because plastic film strips may remain attached to the slices.

    Product
    Fat Free Pasteurized Prepared Cheese Product: HYVEE 12/12OZ FAT FREE SWISS CHS, 7545009327. BORDEN 12/12OZ SWISS FAT FREE WHT, 5300000679.
    Category
    Food
    Distribution
    39 states
  • HighFDA (Devices)·Z-2295-2015·2015-08-05

    Anspach 5MM Fluted Ball Dissection Tools Recalled for Inconsistent Shaft Exposure

    The Anspach Effort, Inc. is recalling 79 Anspach 5MM Fluted Ball dissection tools because the shaft exposure may be greater than labeled when used with certain attachments.

    Product
    ANSPACH - 5MM Fluted Ball, 2 mm Shaft Exposure; REF M-5B-2-G1. Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2314-2015·2015-08-05

    Siemens ACUSON S Family Ultrasound Systems Recalled for Measurement Error

    Siemens is recalling ACUSON S 1000, S 2000, and S 3000 ultrasound systems due to a potential measurement error in the Doppler manual trace tool that could lead to misdiagnosis.

    Product
    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2257-2015·2015-08-05

    Philips CT Systems Recalled for Software and Hardware Defects

    Philips is recalling 82 Ingenuity Core CT systems due to software errors affecting image quality, dose control, and heart rate monitoring.

    Product
    Computed Tomography X-ray Systems Ingenuity Core. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2316-2015·2015-08-05

    Symmetry Surgical Disposable Towel Clamp Recalled for Sterility Assurance

    Symmetry Surgical is recalling 2,708 units of disposable towel clamps due to a lack of sterility assurance. The affected sterile products were distributed in the US, Germany, and Mexico.

    Product
    SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. Apply clamps parallel to the skin with the angled jaws forming a "V" shape between clamp and drape.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2260-2015·2015-08-05

    Medtronic MiniMed Recalls 620G and 640G Insulin Pumps for Bolus Screen Issue

    Medtronic MiniMed is recalling 620G and 640G insulin pumps because the bolus screen may fail to timeout, displaying outdated dosing information.

    Product
    MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2256-2015·2015-08-05

    Philips Brilliance iCT SP CT Systems Recalled for Software Defects

    Philips Medical Systems is recalling two Brilliance iCT SP CT systems due to software issues affecting image quality, dose control, and heart rate measurement.

    Product
    Computed Tomography X-ray Systems Brilliance iCT SP. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2015·2015-08-05

    Philips Brilliance iCT CT Systems Recalled for Software and Hardware Defects

    Philips is recalling 38 Brilliance iCT CT systems due to software errors affecting dose control, heart rate measurement, and image artifacts.

    Product
    Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2308-2015·2015-08-05

    Anspach 4mm Diamond Ball Dissection Tool Recall for Inconsistent Shaft Exposure

    The Anspach Effort, Inc. is recalling 246 units of the 4mm Diamond Ball dissection tool because the shaft exposure may be greater than labeled when used with certain attachments.

    Product
    ANSPACH - 4MM Diamond Ball, Extends 27MM; REF S-4D-L-G1 all lot numbers Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • HighNHTSA·15V492000·2015-08-05

    Newmar Recalls 2015-2016 Motor Homes Due to Air Suspension Defect

    Newmar is recalling 82 model year 2015-2016 Mountain Aire, King Aire, and Essex motor homes because the air suspension control module may lose power, potentially affecting vehicle control.

    Product
    NEWMAR — NEWMAR KING AIRE, MOUNTAIN AIRE, ESSEX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2258-2015·2015-08-05

    Philips CT Systems Recalled for Software and Hardware Defects

    Philips is recalling 139 Ingenuity Core 128 CT scanners due to software errors affecting image quality, dose control, and heart rate monitoring.

    Product
    Computed Tomography X-ray Systems Ingenuity Core 128. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2315-2015·2015-08-05

    Tornier Aequalis Humeral Nail Targeting Jig Recalled for Mast Separation

    Tornier, Inc. is recalling 99 Aequalis Humeral Nail Targeting Jigs because the mast can separate from the boom, potentially affecting surgical alignment and screw fixation.

    Product
    Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.
    Category
    Medical Device
    Distribution
    17 states