RecallRadar

FDA Device recall Z-3043-2017

Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140

On 2017-08-23 the FDA classified a Class II recall of Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140 by Boston Scientific, citing boston Scientific (BSC) has received complaints for cracked trays on the Encore device.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-3043-2017
ClassificationClass II
Statusterminated
Initiated2017-06-15
Published2017-08-23
Last updated2026-09-13 11:54 UTC
CompanyBoston Scientific
Distributionn/a

Product

Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140

Reason

Boston Scientific (BSC) has received complaints for cracked trays on the Encore device.

Identifiers

code_info
Serial Numbers: (a) 19563006, 19587644, 19623142, 19650458, 19704550, 19725489, 19769215, 20054530, 20077271, 20083051…Serial Numbers: (a) 19563006, 19587644, 19623142, 19650458, 19704550, 19725489, 19769215, 20054530, 20077271, 20083051, 20127928, 20159518, 20202728, 20206930, 20242335, 20285571, 20309573, 20309574, 20336380, 20394218, 20423644, 20423645, 20456071, 20481170, 20534557 (b) 19640750, 19667072, 19704551, 19755302, 19755307, 19785021, 19808183, 20030825, 20060033, 20087896, 20117909, 20159601, 20171449, 20206929, 20233700, 20256035, 20279769, 20303751, 20336385, 20336386, 20364928, 20364929, 20364930, 20423650, 20472532, 20493563, 20507373, 20534581 (c) 20157078, 19623019, 19755304, 20056496, 20146417, 20264032, 20456079 (d) 19594194, 19717352, 19808180, 20121252, 20223176, 20336387, 20394350, 20534582

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-3043-2017%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.