RecallRadar

FDA Device recall Z-2014-2017

16cm Minimally Invasive Attachment Product Usage: Pneumatic system

On 2017-05-10 the FDA classified a Class II recall of 16cm Minimally Invasive Attachment Product Usage: Pneumatic system by The Anspach Effort, citing supplied Directions for Use (DFU) did not contain a recommended service interval.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2014-2017
ClassificationClass II
Statusterminated
Initiated2016-10-06
Published2017-05-10
Last updated2026-09-13 11:54 UTC
CompanyThe Anspach Effort
DistributionUS

Product

16cm Minimally Invasive Attachment Product Usage: Pneumatic system

Reason

Supplied Directions for Use (DFU) did not contain a recommended service interval.

Identifiers

code_infoAll serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. MIA16.

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-2014-2017%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.