The Recall Desk
ModerateFDA (Devices)·Z-2239-2016·Announced 2016-07-27

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.

What this means for you

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
Category
Medical Device — Surgical Instruments
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

Distributed in 52 states:

Related recalls

Same manufacturer · Hologic, Inc

See all →

Same hazard · structural defect

See all →