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Blood Pressure Kit,Sphymomanometer with Dual Head Stethoscope

Dynarex Corporation · Model 7099 · UDI-DI 00616784709925

DXQ
10
510(k) clearances
507
Adverse events (2 deaths)
27
Recalls
172
Facilities

Description

Includes: Large easy-to-read-pin-stop gauge, 300 mmHg calibrated scaled, Self-adjusting nylon cuff for easy one-handed operation, Separate Dual Head Stethoscope, Black zipper carry case.

Recalls

DateFirmReason
2025-10-28Baxter Healthcare CorporationReplacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
2025-03-21Baxter Healthcare CorporationUndeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
2025-03-21Baxter Healthcare CorporationUndeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
2025-03-21Baxter Healthcare CorporationUndeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
2025-03-21Baxter Healthcare CorporationUndeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
2025-03-21Baxter Healthcare CorporationUndeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
2024-04-09GE Medical Systems Information Technologies IncUse of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.
2022-05-16Volcano CorpDue to a potential failed sterilization process.
2019-07-12ICU Medical, Inc.Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate monitoring data, unit shutdown,
2019-06-03Suntech Medical, Inc.Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was placed in the package.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.