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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74781

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 04, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Reshape Medical Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesity related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.

Z-2552-2016
Recall number
Z-2552-2016
Initiated
May 04, 2016
Classification
Class II
Status
Terminated
Recalling firm
Reshape Medical Inc
Quantity
56 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
error during manufacturing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to a suspected misalignment of the connection between the proximal balloon cap of the implant and the delivery catheter. The possible misalignment is the result of an assembly error during manufacturing and may lead to leakage of saline solution during the balloon inflation procedure.

Code information

160317-001, 160371-002, 160317-003, 160324-010.

Distribution pattern

US: Distribution to the states of : NY, OH and CA.