Recall events
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Event 84332
Event summary
Timeline bucket November 13, 2019
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording Medtronic Xomed, 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
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
Lamicel 20PK 3MM INTL Cervical dilator
Z-0733-2020
Recall number Z-0733-2020
Initiated November 13, 2019
Classification Class II
Status Ongoing
Quantity 29320 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Routine sterilization dose does not meet the required Sterility Assurance Level.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0733-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[35424]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
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Inspect official wording and provenance
Reason for recall Routine sterilization dose does not meet the required Sterility Assurance Level.
Code information UDI: 20885074749024; SPONGE 2202-501EX LAMICEL 20PK 3MM INTL; 2202-501EX; Lots 9646605, 9651239, 9651240, 9651245, 9667694, 9667697, 9667756, 9669946, 9686127, 9686128, 9688076, 9693346, 9693347, 9693339, 9775264, 9799705, 9799708, 9811174, 9812616, 9819177, 9819513, 9819516, 9851438
Distribution pattern Affected product was only distributed in Japan.
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[9638]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 3
Lamicel 20PK 5MM INTL
Z-0734-2020
Recall number Z-0734-2020
Initiated November 13, 2019
Classification Class II
Status Ongoing
Quantity 307 packs; 6140 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Routine sterilization dose does not meet the required Sterility Assurance Level.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0734-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[41366]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Routine sterilization dose does not meet the required Sterility Assurance Level.
Code information UDI: 20885074749055; SPONGE 2203-501EX LAMICEL 20PK 5MM INTL; 2203-501EX; Lots 9642542, 9657414, 9657415, 9657416, 9677915, 9707331, 9707338, 9707334, 9712918
Distribution pattern Affected product was only distributed in Japan.
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[11258]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 3
Lamicel 10PK 10MM INTL
Z-0735-2020
Recall number Z-0735-2020
Initiated November 13, 2019
Classification Class II
Status Ongoing
Quantity 10 packs; 100 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Routine sterilization dose does not meet the required Sterility Assurance Level.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0735-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[53144]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Routine sterilization dose does not meet the required Sterility Assurance Level.
Code information UDI: 20613994728917; SPONGE 2205-501EX LAMICEL 10PK 10MM INTL; 2205-501EX; Lots 9767987, 9806170
Distribution pattern Affected product was only distributed in Japan.
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[12991]
FDA event record
· Exact recall-number query on openFDA
