FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: Cuffable Blood Pressure Cuffs; Manufactured for Vital Signs, Inc., a GE Healthcare Company 20 Campus Road, Totowa, NJ 07512 Made in Mexico. The cuff is used to determine a subject's blood pressure.
- Recall number
- Z-2581-2011
- Recalling firm
- GE Healthcare, LLC
- Product
- Cuffable Blood Pressure Cuffs; Manufactured for Vital Signs, Inc., a GE Healthcare Company 20 Campus Road, Totowa, NJ 07512 Made in Mexico. The cuff is used to determine a subject's blood pressure.
- Status
- Terminated
- Initiated
- 2011-04-26
- Posted
- 2011-06-22
- Terminated
- 2013-05-28
- Reason
- BP cuffs may not properly inflate due to a leak
- Root cause
- Device Design
- Action
- GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 26, 2011 to all affected customers. The letter identified the product, the problem and the action to be taken. Customers were instructed to discontinue use of the product, isolate all affected products, return only unused products and distribute this letter to any other healthcare institutions that are potentially affected by this issue. The letter asks that each customer complete and return the enclosed confirmation form via fax to 800-535-7923, in order to confirm receipt of the notification letter. For any questions, contact your local Vital Signs Account Manager or the International Customer Service at 1-800-932-0760.
- Quantity
- 2,684,996 units
- Distribution
- Worldwide Distribution -- USA (nationwide) including Puerto Rico and countries of: Argentina, Australia, Belgium, Canada, Chile, Ecuador, Finland, Germany, Hong Kong, Israel, Italy, Latvia, Lebanon, Nicaragua, Panama, Peru, Saudi Arabia, Slovenia, UK, Uruguay and Venezuela
- Lot, serial or model codes
- 510(k) K911213 Medical Device Listing Number D110124 for year 2009- Lot #2689- Lot #3659 For year 2010 - Lot #0010-Lot #2530
- 510(k) numbers
- ["K911213"]
- PMA numbers
- not on file
- Product code
- DXQ
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28