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.

25776–25800 of 50447

  • HighFDA (Devices)·Z-1625-2019·2019-06-05

    Maquet Getinge Rotaflow Support Pack Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Rotaflow Support Packs because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 48003 Rotaflow ONLY Support Pack Material:709000490
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1530-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BEQ-TOP 25001 MONTEFIORE Material: 701053906
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1641-2019·2019-06-05

    Maquet Neonate ECC Tubing Sets Recalled for Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BEQ-TOP 28601 NEONATE ECC QPiD Material: 701051935R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1502-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization.

    Product
    Maquet Getinge-BEQ-TOP 17207 3/8 ECC PACK Material: 701049346
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1621-2019·2019-06-05

    Maquet Getinge Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BEQ-T 25502 1/4 Better Bladder Material: 709000434
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1548-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 26402 ECC Pack Recall Due to Sterility Concerns

    Maquet Cardiovascular is recalling specific batches of ECC Packs because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 26402 ECC PACK Material: 701062310
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1619-2019·2019-06-05

    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-T 9409 Lurie Chlds Large 3/8 Material: 709000428
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1649-2019·2019-06-05

    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.

    Product
    Maquet Getinge- BEQ-TOP 32100 Adult Custom Pack Material:701054438R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1691-2019·2019-06-05

    NeuroLogica Recalls Samsung GM85 Mobile Digital X-ray Imaging Systems

    NeuroLogica is recalling 288 Samsung GM85 Mobile Digital X-ray Imaging Systems due to a potential safety latch issue that could cause the arm to fall.

    Product
    Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1679-2019·2019-06-05

    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.

    Product
    Maquet Getinge- BEQ-T 9411 Lurie Children's 1/4 ADAPT Material:709000485R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1665-2019·2019-06-05

    Maquet Getinge Children's ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Children's Large ECC Packs because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 49101 Childrens Large ECC Pack Material: 701067069R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1533-2019·2019-06-05

    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, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 32100 ADULT CUSTOM PAC Material:701054438
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1552-2019·2019-06-05

    Maquet Custom Tubing Sets Recalled for Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BEQ-TOP 30901 CUSTOM CPB PACK Material:701063071
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1645-2019·2019-06-05

    Maquet Custom Tubing Sets Recalled for Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BEQ-TOP 250011/4 1/4 Less than 20 kg up Material: 701053906R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1603-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of custom tubing sets for extracorporeal circulation because the design may prevent proper sterilization gas flow.

    Product
    Maquet Getinge-BEQ-T 51502 Ochsner ECC Ancillary Pack Material:709000115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1673-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because the stopcock design may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- BO-T 2303 3/8" x 3/8" Adult Pack Material: 709000004R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1569-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific ECC tubing sets because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 27609 ECC PACK 1/4" Material: 701065504
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1503-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BEQ-T-22800 Material: 701049506
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1570-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BEQ-TOP 31203 CUSTOM PACK NEO Material: 701065510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1600-2019·2019-06-05

    Maquet Pediatric ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling pediatric extracorporeal circulation tubing sets because a design flaw may prevent proper sterilization of stopcock ports.

    Product
    Maquet Getinge-BEQ-TOP 50903 Custom ECC Pack-Pedriatric Material: 709000078
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1498-2019·2019-06-05

    Maquet Getinge Tubing Packs Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific tubing packs for extracorporeal circulation because the design may prevent proper sterilization gas flow, compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 15800 TUBING PACK Material: 3000065087
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1627-2019·2019-06-05

    Maquet Getinge-BEQ-TOP Custom Tubing Sets Recalled for Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BEQ-TOP 31604 CHKD 1/4" ECC Material: 709000518
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1546-2019·2019-06-05

    Maquet Pediatric CPB Packs Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling Pediatric CPB Packs because a design feature may prevent sterilization gas from reaching all fluid paths, compromising sterility.

    Product
    Maquet Getinge-BEQ-T 4906 PEDIARIC CPB PACK Material: 701056041
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1618-2019·2019-06-05

    Maquet Getinge-T 5220 UAB Hospital Accessory Recall for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because the design may prevent proper sterilization gas flow, potentially compromising sterility.

    Product
    Maquet Getinge-T 5220 UAB Hospital Accessory Material: 709000426
    Category
    Medical Device
    Distribution
    Distributed nationwide