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.

25876–25900 of 50450

  • HighFDA (Devices)·Z-1462-2019·2019-05-29

    Zimmer V-TEK Orthopedic Screws Recalled for Potential Material Deviation

    Zimmer GmbH is recalling V-TEK standard-countersink screws because they may have been manufactured from a different material than specified.

    Product
    V-TEK", standard-countersink, cannulated, round shaft, Item Number 28.66.110
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1455-2019·2019-05-29

    Zimmer GmbH Recalls CBS Micro Countersink Cannulated Round-Shaft Screws

    Zimmer GmbH is recalling CBS micro countersink cannulated round-shaft screws because they may be made from the wrong material.

    Product
    CBS micro, countersink, cannulated, round-shaft, Item Number 503004341
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1416-2019·2019-05-29

    Zimmer GmbH Recalls 15mm Surgical Drills Due to Material Concerns

    Zimmer GmbH is recalling 15mm surgical drills that may have been manufactured from incorrect materials. The products were distributed to 41 US states.

    Product
    Drill, 15mm stop, 1x76mm, AO , Item Number 502015115
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1412-2019·2019-05-29

    Elekta Recalls Leksell GammaPlan 11.1 Software Due to Margin Overestimation

    Elekta Instrument AB is recalling Leksell GammaPlan 11.1 software because the margin tool overestimates treatment margins in certain areas.

    Product
    Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1395-2019·2019-05-29

    Boston Scientific Recalls Auriga 30 Laser Systems Due to Power Degradation

    Boston Scientific is recalling eight Auriga 30 laser systems worldwide because a mechanical cooling issue may cause faster-than-normal power degradation and low power errors.

    Product
    AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1450-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Potential Material Deviation

    Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the specifications.

    Product
    Drill, cannulated, 4x90mm, round shaft, Item Number 502015640
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1388-2019·2019-05-29

    Stryker Visum LED Surgical Lighting System Component Recall

    Stryker is recalling 3,176 EDS Light Suspension components for the Visum LED Surgical Lighting System due to a potential assembly defect in the joint.

    Product
    EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS Light Suspension, Central Axis, 5P/FP; 0682001298, EDS Light Suspension, Central Axis, 5P; 0682001299, EDS Light Suspension…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1418-2019·2019-05-29

    Zimmer GmbH Recalls 26mm Orthopedic Drills Due to Material Concerns

    Zimmer GmbH is recalling 26mm orthopedic drills that may have been manufactured from a different material than specified.

    Product
    Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015124
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1454-2019·2019-05-29

    Zimmer GmbH Recalls MaxiCan 4.5 Countersink Due to Material Concerns

    Zimmer GmbH is recalling MaxiCan 4.5 countersinks because they may be made from a different material than specified. The products were distributed to 40 US states.

    Product
    MaxiCan 4.5 countersink, cannulated, AO, Item Number 503004177
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1458-2019·2019-05-29

    Zimmer CBS 4.0 Countersink Recalled for Material Specification Deviation

    Zimmer GmbH is recalling CBS 4.0 countersinks because they may have been manufactured from a material different from the defined specifications.

    Product
    CBS 4.0 countersink, cannulated, 15mm stop, AO, Item Number 503004352
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1448-2019·2019-05-29

    Zimmer GmbH Recalls V-TEK IVP Step Drills Due to Material Concerns

    Zimmer GmbH is recalling V-TEK IVP step drills because an investigation found they may be made from a different material than specified.

    Product
    V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 502015637
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1486-2019·2019-05-29

    Zimmer GmbH Recalls Contra-Angle Drills Due to Material Concerns

    Zimmer GmbH is recalling contra-angle drills that may have been manufactured from a different material than specified.

    Product
    Drill, contra-angle, 1.5x85mm, Item Number ST502015706
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1430-2019·2019-05-29

    Zimmer GmbH Recalls 2.7mm Orthopedic Drills Due to Material Concerns

    Zimmer GmbH is recalling 2.7mm orthopedic drills because they may be made from a different material than specified. The products were distributed to 40 US states.

    Product
    Drill for 2.7mm screw, 2x120mm, AO, Item Number 502015212
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1466-2019·2019-05-29

    Zimmer V-TEK Cannulated AO Screws Recalled for Material Specification Deviation

    Zimmer GmbH is recalling V-TEK standard-countersink, cannulated, AO screws because they may have been manufactured from a material different from the defined specifications.

    Product
    V-TEK", standard-countersink, cannulated, AO, Item Number ST28.66.111
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1392-2019·2019-05-29

    Boston Scientific Recalls Auriga XL 4007 Laser Systems for Cooling Defect

    Boston Scientific is recalling 27 Auriga XL 4007 laser systems worldwide due to a mechanical cooling issue that may cause the device to stop emitting laser pulses during surgery.

    Product
    AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1481-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Material Specification Concerns

    Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the defined specifications.

    Product
    Drill, cannulated, 3x90mm, round shaft, Item Number ST502015630
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1397-2019·2019-05-29

    Boston Scientific Recalls Auriga 30 Laser Systems Due to Power Degradation

    Boston Scientific is recalling 18 Auriga 30 laser systems worldwide because a mechanical cooling issue may cause faster-than-normal power degradation and low power errors.

    Product
    AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1446-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Material Specification Concerns

    Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the defined specifications.

    Product
    Drill, cannulated, 3.5x90mm, round shaft, Item Number 502015635
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1415-2019·2019-05-29

    Stryker 15mm Drill Recalled for Potential Material Deviation

    Zimmer GmbH is recalling Stryker 15mm drills because an investigation found they may have been manufactured from a different material than specified.

    Product
    Drill, 15mm stop, 1x83mm, Stryker, Item Number 502015114
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1472-2019·2019-05-29

    Zimmer GmbH Recalls 3.5mm Orthopedic Drill Due to Material Concerns

    Zimmer GmbH is recalling specific 3.5mm orthopedic drills because they may have been manufactured from a different material than specified.

    Product
    Drill for 3.5mm screw, 2.5x120mm, AO, Item Number ST502015216
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1480-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Material Concerns

    Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a different material than specified.

    Product
    Drill, cannulated, 2.8x120mm, AO, Item Number ST502015628
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1471-2019·2019-05-29

    Zimmer GmbH Recalls 2.7mm AO Surgical Drills Due to Material Concerns

    Zimmer GmbH is recalling 2.7mm AO surgical drills because they may have been manufactured from a material different from specifications.

    Product
    Drill for 2.7mm screw, 2x120mm, AO, Item Number ST502015212
    Category
    Medical Device
    Distribution
    42 states