Z-0655-2017Class II

SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS...

Name: Z-0655-2017 SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS...
Creator: Hologic, Inc
Published: 2016-10-28
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2016-10-28 / Terminated / root cause: packaging

FDA source

Hologic, Inc began a recall of SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For... on 2016-10-28. FDA classified it as Class II and gives the reason as "Breach in sterile barrier compromising product sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0655-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-28
Posted: 2016-11-22
Terminated: 2017-08-18
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
Product code: HHM Sound, Uterine
Reason for recall: Breach in sterile barrier compromising product sterility
Root cause tag: packaging
FDA 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 in commerce: 600 units (US) ; 24 units (OUS)
Distribution: Worldwide Distribution - US (Nationwide) and Internationally to Finland and Austria.
Product codes and lots: Lot Code US: 16E25RC 16E25RD 16F16R Lot Code OUS: 16E25RB

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0655-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0655-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-22

Product code HHM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)