Home › WELCH ALLYN, INC. › Welch Allyn, Inc.
Welch Allyn, Inc.
WELCH ALLYN, INC. · Model 901092 · UDI-DI 00732094083149
DXQ
Prescription
10
510(k) clearances
492
Adverse events (2 deaths)
27
Recalls
170
Facilities
Description
Welch Allyn Tycos DS58 Hand Aneroid Sphygmomanometer with DuraShock Gear Free, Super Shock Resistant Technology; Jewel Movement, Laser Engraved Dial, Lifetime Calibration Warranty; Zipper Case; Three-Cuff Kit: Size-09, Size-11, and Size-12; Reusable (Two Piece), 1-Tube Cuffs
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-28 | Baxter Healthcare Corporation | Replacement 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. |
| 2025-03-21 | Baxter Healthcare Corporation | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| 2025-03-21 | Baxter Healthcare Corporation | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| 2025-03-21 | Baxter Healthcare Corporation | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| 2025-03-21 | Baxter Healthcare Corporation | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| 2025-03-21 | Baxter Healthcare Corporation | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| 2024-04-09 | GE Medical Systems Information Technologies Inc | Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements. |
| 2022-05-16 | Volcano Corp | Due to a potential failed sterilization process. |
| 2019-07-12 | ICU 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, |
| 2019-06-03 | Suntech 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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData 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.