Recall events
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Event 97649
Event summary
Timeline bucket September 24, 2025
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording Aesculap 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
Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Description: SEALING UNIT F/10/12MM TROCARS W.REDUCER Component: N/A
Z-0309-2026
Recall number Z-0309-2026
Initiated September 24, 2025
Classification Class II
Status Ongoing
Quantity 26 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
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-0309-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52666]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Code information Model No EK083P; UDI-DI: 04046963417710; Lots 52978946, 52991996, 53002275, 53004669, 53006807, 52941286, 52956527, 52956740, 52956952, 52957393, 52967167
Distribution pattern Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, MD, NE, NM, NY, OR, PA, WA, WI and the country of Canada.
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[2066]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 4
Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description: SEALING CAP FOR 10/12MM TROCARS Component: N/A
Z-0310-2026
Recall number Z-0310-2026
Initiated September 24, 2025
Classification Class II
Status Ongoing
Quantity 140 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
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-0310-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52671]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Code information Model No EK085P; UDI-DI: 04046963620042; Lots 52987668, 52993442, 53001930, 53008562, 53013543, 52948710, 52954233, 52957528, 52966111, 52979586
Distribution pattern Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, MD, NE, NM, NY, OR, PA, WA, WI and the country of Canada.
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[2144]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 4
Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description: SEALING UNIT FOR 10/12MM TROCARS Component: N/A
Z-0311-2026
Recall number Z-0311-2026
Initiated September 24, 2025
Classification Class II
Status Ongoing
Quantity 26 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
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-0311-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52674]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Code information Model No EK086P; UDI-DI: 04046963425272; Lots 52968398, 52975386, 52988022, 52993532, 53008999, 53009000, 53009001, 53009417
Distribution pattern Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, MD, NE, NM, NY, OR, PA, WA, WI and the country of Canada.
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[38934]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 4
Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description: REDUCING CONVERTER 10/12MM TO 5MM Component: N/A
Z-0312-2026
Recall number Z-0312-2026
Initiated September 24, 2025
Classification Class II
Status Ongoing
Quantity 155 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
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-0312-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11647]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Code information Model No EK087P; UDI-DI: 04046963620059; Lots 52974276, 52952133, 52954633, 52959357, 52964442, 52968887, 52972214, 52977427, 52981208, 52985519, 52988828, 52992514, 52993617, 52997919, 53002094, 53004347, 53006380, 53007625, 53010869, 53013557
Distribution pattern Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, MD, NE, NM, NY, OR, PA, WA, WI and the country of Canada.
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[38287]
FDA event record
· Exact recall-number query on openFDA
