Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
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.
Maquet Cardiovascular is recalling specific batches of Getinge-BO-T 52360 Cardioplegia Packs because a design feature may prevent proper sterilization of the stopcock ports.
Maquet Cardiovascular is recalling specific LVAD tubing sets because a design feature may prevent sterilization gas from reaching all parts, compromising sterility.
Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent sterilization gas from reaching all fluid paths.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because the design may prevent proper sterilization gas flow, compromising sterility.
Maquet Cardiovascular is recalling specific LVAD tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization of the stopcock ports.
Maquet Cardiovascular is recalling Adult ECC Packs because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.
Maquet Cardiovascular is recalling Small Patient ECC Packs because a design flaw may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design feature may prevent sterilization gas from reaching all parts of the device.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.
Maquet Getinge-BO-TOP tubing sets are being recalled because a design feature may prevent sterilization gas from reaching all parts, compromising sterility.
Maquet Cardiovascular is recalling specific tubing packs for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, potentially compromising sterility.
Maquet Cardiovascular is recalling specific BEQ-TOP 5210 ECC Sets because a design flaw may prevent proper sterilization of the stopcock ports.
Maquet Cardiovascular is recalling specific batches of BO-TOP 48400 OR PACK tubing sets because a design flaw may prevent proper sterilization of the stopcock ports.
Maquet Cardiovascular is recalling specific batches of Getinge-BEQ-TOP 32200 ECC Packs because a design feature may prevent proper sterilization of the stopcock ports.
Maquet Cardiovascular is recalling specific ECC tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific Custom CPB Packs because a design feature may prevent proper sterilization, potentially compromising sterility.
Abbott is recalling Alinity i Processing Modules due to potential loose cable connections that could cause reagent cooler failure, leading to burn or shock injuries.
Maquet Cardiovascular is recalling specific priming lines for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, potentially compromising sterility.
Teleflex Medical is recalling RUSCH LASERTUBE devices because the laser guard foil partially separated or detached at the edges.
Zimmer Surgical Inc is recalling Alvarado and Alvarado II knee holder components due to potentially inadequate cleaning procedures that may leave foreign material on the devices.
Maquet Cardiovascular is recalling BEQ-TOP 32200 ECC Packs because a design flaw may prevent sterilization gas from reaching all fluid paths, compromising sterility.