Recall events
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Event 92279
Event summary
Timeline bucket April 24, 2023
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Avanos Medical, 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
5 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 5
AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
Z-1684-2023
Recall number Z-1684-2023
Initiated April 24, 2023
Classification Class II
Status Terminated
Quantity 33 cases (165 cassettes)
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Some of the ambIT kits were potentially distributed without an air in-line filter.
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1684-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4341]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Some of the ambIT kits were potentially distributed without an air in-line filter.
Code information Lot Number (Expiration Date): 30181360 (17 Dec 2023), 30177648 (17 Dec 2023)
Distribution pattern Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[36970]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 5
AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
Z-1685-2023
Recall number Z-1685-2023
Initiated April 24, 2023
Classification Class II
Status Terminated
Quantity 57 cases (285 cassettes)
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Some of the ambIT kits were potentially distributed without an air in-line filter.
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1685-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17078]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Some of the ambIT kits were potentially distributed without an air in-line filter.
Code information Lot Number (Expiration Date): 30177647 (17 Dec 2023); 30174128 (14 Oct 2023)
Distribution pattern Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[37623]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 5
SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
Z-1686-2023
Recall number Z-1686-2023
Initiated April 24, 2023
Classification Class II
Status Terminated
Quantity 45 cases (225 cassettes)
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Some of the ambIT kits were potentially distributed without an air in-line filter.
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1686-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[28151]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Some of the ambIT kits were potentially distributed without an air in-line filter.
Code information Lot Number (Expiration Date): 30195563 (17 Jan 2025); 30190578 (17 Jan 2025)
Distribution pattern Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[37565]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 5
SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568
Z-1687-2023
Recall number Z-1687-2023
Initiated April 24, 2023
Classification Class II
Status Terminated
Quantity 40 cases (200 cassettes)
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Some of the ambIT kits were potentially distributed without an air in-line filter.
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1687-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21878]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Some of the ambIT kits were potentially distributed without an air in-line filter.
Code information Lot Number (Expiration Date): 30191805 (17 Jan 2025)
Distribution pattern Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[36935]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 5
ambIT Cassette Filter Male Luer, Product Code: 220266
Z-1688-2023
Recall number Z-1688-2023
Initiated April 24, 2023
Classification Class II
Status Terminated
Quantity 1155 total, 280 individually packaged
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Some of the ambIT kits were potentially distributed without an air in-line filter.
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1688-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[40491]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Some of the ambIT kits were potentially distributed without an air in-line filter.
Code information Lot Number (Expiration Date): F201701 (17 Jan 2025)
Distribution pattern Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[36993]
FDA event record
· Exact recall-number query on openFDA
