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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83527

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

Open FDA event record

Event summary

Timeline bucket
August 07, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Intersurgical 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

4 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 4

Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.

Z-0784-2020
Recall number
Z-0784-2020
Initiated
August 07, 2019
Classification
Class II
Status
Terminated
Recalling firm
Intersurgical Inc
Quantity
115,200 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.

Code information

Lot numbers: 2181793, 2182007, 2182830, 2183105, 2183345(3183345), 2190034, 2190139, 2191204, 2191327

Distribution pattern

US Nationwide

device · product 2 of 4

Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030. Airway connector.

Z-0785-2020
Recall number
Z-0785-2020
Initiated
August 07, 2019
Classification
Class II
Status
Terminated
Recalling firm
Intersurgical Inc
Quantity
46,450 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.

Code information

Lot numbers: 2180448, 2180742, 2181001

Distribution pattern

US Nationwide

device · product 3 of 4

Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector.

Z-0786-2020
Recall number
Z-0786-2020
Initiated
August 07, 2019
Classification
Class II
Status
Terminated
Recalling firm
Intersurgical Inc
Quantity
19,200 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.

Code information

Lot numbers: 2180531, 2181808, 2182241, 2182533

Distribution pattern

US Nationwide

device · product 4 of 4

Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airway connector.

Z-0787-2020
Recall number
Z-0787-2020
Initiated
August 07, 2019
Classification
Class II
Status
Terminated
Recalling firm
Intersurgical Inc
Quantity
50,400 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.

Code information

Lot numbers: 2182536, 2182852, 2183161, 2190350, 2190531, 2190617, 2191025, 2191591

Distribution pattern

US Nationwide