RecallRadar

FDA Device recall Z-1891-2017

DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE

On 2017-05-10 the FDA classified a Class II recall of DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE by Perouse Medical, citing complaints regarding broken blister.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1891-2017
ClassificationClass II
Statusterminated
Initiated2017-04-05
Published2017-05-10
Last updated2026-09-13 11:54 UTC
CompanyPerouse Medical
DistributionAZ, MN, TN

Product

DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND

Reason

Complaints regarding broken blister.

Identifiers

code_info
1 5045606 - 15055430 - 15065340 - 15065685 -15065744- 15065858- 15065970- 15075121 - 15075265 - 15075411- 15075821 - 1…1 5045606 - 15055430 - 15065340 - 15065685 -15065744- 15065858- 15065970- 15075121 - 15075265 - 15075411- 15075821 - 1 5075851 - 15075942 - 15085001 - 15085075 -15085378- 15085435 -15085515- 15085555 -15105052- 15125214- 16015267- 16025034- 16025640

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-1891-2017%22

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