Exact FDA event identifier

Event 76276

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

Open FDA event record

Event summary

Timeline bucket: September 20, 2016
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Custom Medical Specialties, 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

CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.

Z-1234-2017

Recall number: Z-1234-2017
Initiated: September 20, 2016
Classification: Class II
Status: Ongoing
Recalling firm: Custom Medical Specialties, Inc.
Quantity: 80 syringes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Sterility of syringe product could not be assured.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of syringe product could not be assured.

Code information

Lots 40629-1609 an 40631-1609

Distribution pattern

US Distribution to ID and OR.