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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82499

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

Open FDA event record

Event summary

Timeline bucket
March 21, 2019
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
ROi Consolidated Service Center (CSC)

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

Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.

Z-2220-2019
Recall number
Z-2220-2019
Initiated
March 21, 2019
Classification
Class II
Status
Ongoing
Quantity
261 packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.

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

Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.

Code information

Item Number (Lot Number, Expiration Date): 800096004 (044343D, 43590); 800096004 (048023D, 43722); 800096004 (049262D, 43757); 800096004 (052020D , 43856); 800096004 (054482D, 43948); 800096004 (057619D, 44035); 800096005 (059908E , 44080); 800096005 (062938E , 44151); 800096005 (65606E, 44232);

Distribution pattern

Distributed to LA and MO

device · product 2 of 2

Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.

Z-2221-2019
Recall number
Z-2221-2019
Initiated
March 21, 2019
Classification
Class II
Status
Ongoing
Quantity
312 packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.

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

Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.

Code information

Item Number (Lot Number, Expiration Date): 880341004 (043444D, 43566); 880341005 (047474E, 43706); 880341005 (049043E, 43750);

Distribution pattern

Distributed to LA and MO