Z-0351-2018Class II

Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880

Name: Z-0351-2018 Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
Creator: Hologic, Inc.
Published: 2017-07-07
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2017-07-07 / Terminated

FDA source

Hologic, Inc. began a recall of Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880 on 2017-07-07. FDA classified it as Class II and gives the reason as "The firm is implementing a product correction involving its Affirm Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide)...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0351-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-07
Posted: 2018-01-14
Terminated: 2018-04-04
Recalling firm: Hologic, Inc.
Product: Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
Product code: OIJ Biopsy Needle Guide Kit
Reason for recall: The firm is implementing a product correction involving its Affirm Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) issue that could impact needle alignment for all the left-approach lateral biopsy procedures. This may have an impact on the position of the needle within the breast, and thus on the aspiration of the intended tissue. This impact is case-dependent and detectable when imagining is used to confirm needle position and/or tissue acquisition during and after a procedure. There are no known instances of illness or injury.
FDA root cause: Component change control
Action: Letter
Quantity in commerce: 12 (U.S.)
Distribution: US and OUS
Product codes and lots: UDI Number: 15420045506817 Serial Numbers: LAT1200100 LAT1200165

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0351-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0351-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-14

Product code OIJ

K161575Class IIAffirm Lateral Arm Upright Biopsy AccessoryHologic / cleared 2016-08-10

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)