Hologic Recalls ATEC Suction Canisters Due to Cracked Lids
Hologic is recalling 16,870 ATEC Suction Canisters because the lids may crack. These devices are used to collect fluid during breast biopsies.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a structural defect (cracked lids) in a medical device used during a procedure, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Hologic, Inc. is recalling 16,870 units of ATEC Suction Canisters with Lid 490 cc. The recall is due to reports that the canister lids may crack. These prescription-only medical devices are used to collect fluid during breast biopsy procedures.
The affected products are identified by Lot Numbers 20150013 and 20150014. The devices were distributed worldwide, including in all 50 U.S. states, the District of Columbia, Puerto Rico, and numerous international locations such as Canada, the United Kingdom, Germany, and Australia.
Hologic is the recalling firm. The source text does not specify specific consumer actions or contact information for the recall.
The recalled product
- Product
- ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a breast biopsy.
- Manufacturer
- Hologic, Inc
- Hazard
- Affected units
- 16,870
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 Number: 20150013 and 20150014
Distribution
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