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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91314

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 05, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Turbett Surgical, 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

2 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 2

Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider

Z-1037-2023
Recall number
Z-1037-2023
Initiated
December 05, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Turbett Surgical, Inc.
Quantity
61 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.

Code information

GTIN: 00859464007281 Lot Number: All Lot Numbers Serial Number: All Serial Numbers

Distribution pattern

US Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA, SD, TX, VA, WI.

device · product 2 of 2

Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider

Z-1038-2023
Recall number
Z-1038-2023
Initiated
December 05, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Turbett Surgical, Inc.
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.

Code information

GTIN: 00859464007212 Lot Number: All Lot Numbers Serial Number: All Serial Numbers

Distribution pattern

US Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA, SD, TX, VA, WI.