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.

25851–25875 of 50447

  • HighFDA (Devices)·Z-1565-2019·2019-06-05

    Maquet Getinge Pediatric Pack Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific pediatric packs for extracorporeal circulation because a design issue may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BEQ-T 8069 Pediatric Pack Material: 701064965
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1561-2019·2019-06-05

    Maquet Pediatric ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling pediatric extracorporeal circulation tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 44701 PEDIATRIC ECC Material: 701064825
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1505-2019·2019-06-05

    Maquet Small Patient Tubing Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Small Patient Tubing Packs because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 9403 Small Patient Tubing Pack Material: 701049994
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1568-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, potentially compromising sterility.

    Product
    Maquet Getinge-BO-T 41301 BUMC ECC PACK Material: 701065209
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1634-2019·2019-06-05

    Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent sterilization gas from reaching all parts of the device.

    Product
    Maquet Getinge-BEQ-TOP 21502 ECC Quadrox iD w/RF 3/8" Material:701050060R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·19131·2019-06-04

    Generation Brands Recalls Small Stratton Glass Pendant Light Fixtures

    Generation Brands is recalling Small Stratton glass pendant light fixtures because they can detach from the cord and fall, posing an injury risk.

    Product
    Small Stratton glass pendant light fixtures
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19749·2019-06-04

    Polaris Recalls 2019 RZR XP 4 Turbo S Vehicles Due to Brake Failure

    Polaris is recalling about 1,200 Model Year 2019 RZR XP 4 Turbo S recreational off-highway vehicles because the brakes can fail, posing crash and injury hazards.

    Product
    Model Year 2019 Polaris RZR XP 4 Turbo S recreational off-highway vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19E037000·2019-05-30

    Seats Incorporated Recalls ABTS 6-Way Seats Due to Weld Defect

    Seats Incorporated is recalling ABTS 6-way seats because poor weld penetration may cause the seat to move unexpectedly, increasing injury risk in a crash.

    Product
    SEATS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19748·2019-05-30

    Excel Industries Recalls Zero-Turn Mowers Due to Fire Hazard

    Excel Industries is recalling about 5,400 zero-turn mowers because a wire tie could damage the fuel line, posing a fire hazard. No injuries have been reported.

    Product
    Zero turn lawn mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1381-2019·2019-05-29

    Dornier Diode Laser Fibers Recalled for Sterility Compromise

    Dornier Medtech America is recalling 400 units of Dornier Diode Laser Fibers due to pin hole package failures that compromise product sterility.

    Product
    Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600 micron single use fiber K2011824 600 micron single use fiber K1001293 600 micron single use fiber K2011826 600 micron 5X reusable fiber K1008084 600 micron single use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1411-2019·2019-05-29

    Oakworks Lithotripsy Table Recalled for Incorrect Actuator Assembly Error

    Oakworks Inc. is recalling three Lithotripsy/Urology Tables due to an assembly error involving incorrect actuators for lateral and longitudinal movements.

    Product
    OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks¿ Imaging Tables are radiographic tables intended for use with mobile or compact stationary C-arm Imaging Systems. It is ideally suited for pain management imaging and therapeutic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1431-2019·2019-05-29

    Zimmer GmbH Recalls Osteofresh Arthrodesis Drills Due to Material Concerns

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

    Product
    Osteofresh arthrodesis drill, 2x70mm, center tip, AO, 10mm stop, Item Number 502015213
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1373-2019·2019-05-29

    Polymer Technology Systems Recalls CHOL+HDL+GLU Test Strips

    Polymer Technology Systems is recalling CHOL+HDL+GLU test strips because they may not fit tightly into the optical block, potentially causing incorrect results.

    Product
    CHOL+HDL+GLU test strips, REF 2412
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V401000·2019-05-29

    VCI Recalls Ambulances with Reversed Backup Camera Images

    VCI Emergency Vehicle Specialists is recalling ambulances where backup camera monitors may revert to factory settings, causing reversed images and increasing crash risk.

    Product
    FORD — FORD, CHEVROLET E-450, C4500, F-550, redundant F-350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1488-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Orthopedic Screws Due to Material Concerns

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

    Product
    CBS high, countersink, cannulated, AO, Item Number ST503004542
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1371-2019·2019-05-29

    Polymer Technology Systems Recalls Lipid Panel Test Strips Due to Fit Issues

    Polymer Technology Systems is recalling Lipid Panel test strips because they may not fit tightly into the optical block, potentially causing incorrect results.

    Product
    Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1470-2019·2019-05-29

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

    Zimmer GmbH is recalling specific 2.7mm AO surgical drills because they may be made from a different material than specified. The products were distributed to 41 US states.

    Product
    Drill for 2.7mm screw, 2x100mm, AO, Item Number ST502015208
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1463-2019·2019-05-29

    Zimmer V-TEK Cannulated AO Screws Recalled for Material Deviation

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

    Product
    V-TEK", standard-countersink, cannulated, AO, Item Number 28.66.111
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1434-2019·2019-05-29

    Zimmer GmbH Recalls Stryker 3.5mm Screw Drills Due to Material Concerns

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

    Product
    Drill for 3.5mm screw, 2.5x125mm, stryker, Item Number 502015218
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1464-2019·2019-05-29

    Zimmer GmbH Recalls V-TEK Micro-Countersink Due to Material Concerns

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

    Product
    V-TEK", micro-countersink, round shaft, Item Number 28.66.112
    Category
    Medical Device
    Distribution
    42 states
  • 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