FDA Medical Device Recalls (openFDA)
Hologic, Inc: SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound
- Recall number
- Z-0655-2017
- Recalling firm
- Hologic, Inc
- Product
- SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound
- Status
- Terminated
- Initiated
- 2016-10-28
- Posted
- 2016-11-22
- Terminated
- 2017-08-18
- Reason
- Breach in sterile barrier compromising product sterility
- Root cause
- Package design/selection
- Action
- Hologic notified customers in the United States through Certified letter on 10/28/16. The letter contains instructions with the option of returning or destroying the product, provides contact information, and includes a postage paid return card for the consignee to complete and return to Hologic.Questions or require clarification of the response process please contact 1- 800-442-9892 and selection option 6 and then option 2 for surgical product technical support. For questions regarding this recall call 508-263-8920.
- Quantity
- 600 units (US) ; 24 units (OUS)
- Distribution
- Worldwide Distribution - US (Nationwide) and Internationally to Finland and Austria.
- Lot, serial or model codes
- Lot Code US: 16E25RC 16E25RD 16F16R Lot Code OUS: 16E25RB
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HHM
- Firm FEI
- 1000120743
- Firm city
- Marlborough
- Firm state
- MA
- 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