Hologic, Inc: Medical Device Recalls in 2016

According to to data from the FDA, there were 7 medical device recalls made by Hologic, Inc in 2016. See the details of the recalls below.

You can see similar recalls for other firms.

• Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
• SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)
• SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece Product Usage: The Sure Sight Obturator Introducer Localization System (ILS-OB) is a Hologic accessory kit. It is sold as an independent product for use with the ATEC MRI hand pieces. This sterile accessory kit is available in two lengths, is sold only in the US and has a 6 month shelf life. It contains a single use introducer stylet, introducer sheath, needle guide and localizing obturator
• Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
• ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a breast biopsy.
• SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound
• CF InPlex ASR Card; Catalog Number: 95-0501.