RecallRadar

FDA Device recall Z-1811-2016

Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

On 2016-06-01 the FDA classified a Class II recall of Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges by American Surgical, citing product packaging defective compromising sterility.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1811-2016
ClassificationClass II
Statusterminated
Initiated2016-03-31
Published2016-06-01
Last updated2026-09-13 11:54 UTC
CompanyAmerican Surgical
DistributionUS

Product

Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Reason

Product packaging defective compromising sterility

Identifiers

code_infoLot numbers: Lot Number 2015/09 AI 2015/10 CR 2015/12 BV 2015/12 CV

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1811-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.