Exact FDA event identifier

Event 77842

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

Event summary

Timeline bucket: July 24, 2017
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Epimed International

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

3 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 3

RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter

Z-0087-2018

Recall number: Z-0087-2018
Initiated: July 24, 2017
Classification: Class II
Status: Terminated
Recalling firm: Epimed International
Quantity: 500 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

incomplete seal

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for partially incomplete seal of product, impacting sterility.

Code information

Lot No. 12168200; Ref No. 107-1416.

Distribution pattern

Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.

device · product 2 of 3

COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile

Z-0088-2018

Recall number: Z-0088-2018
Initiated: July 24, 2017
Classification: Class II
Status: Terminated
Recalling firm: Epimed International
Quantity: 300 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

incomplete seal

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for partially incomplete seal of product, impacting sterility.

Code information

Lot No. 12608201; Ref No. 117-2260.

Distribution pattern

Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.

device · product 3 of 3

TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only

Z-0089-2018

Recall number: Z-0089-2018
Initiated: July 24, 2017
Classification: Class II
Status: Terminated
Recalling firm: Epimed International
Quantity: 263 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

incomplete seal

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for partially incomplete seal of product, impacting sterility.

Code information

Lot No. 12358202; Ref No. 125-2035T.

Distribution pattern

Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.