Hologic Recalls SURESOUND22 Uterine Sounds Due to Sterile Barrier Breach
Hologic is recalling SURESOUND22 uterine sound multipacks because a breach in the sterile barrier compromises product sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a breach in sterile barrier compromising sterility, which poses a risk of infection (a risk-of-harm product) without reported illnesses in the source text.
Plain-English summary
Hologic, Inc. is recalling SURESOUND22US Multipack (US Distribution) and SURESOUND22 Multipack (OUS Distribution) containing uterine sounds. The recall is due to a breach in the sterile barrier that compromises the sterility of the product.
The affected products include 600 units for US distribution and 24 units for international distribution. The products were distributed nationwide in the US and internationally to Finland and Austria. The specific lot codes involved are 16E25RC, 16E25RD, and 16F16R for US distribution, and 16E25RB for international distribution.
This is an FDA Class II recall. Healthcare providers and facilities should stop using the affected devices and contact Hologic for instructions on return or disposal. Patients who have used these devices should consult their healthcare provider if they have concerns about potential infection.
The recalled product
- Product
- SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound
- Manufacturer
- Hologic, Inc
- Category
- Medical Device — Uterine Sounds
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code US: 16E25RC 16E25RD 16F16R Lot Code OUS: 16E25RB
Distribution
Distributed nationwide across the United States.
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