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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74563

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

Open FDA event record

Event summary

Timeline bucket
June 22, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
LeMaitre Vascular, 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

7 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 7

Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.

Z-2283-2016
Recall number
Z-2283-2016
Initiated
June 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
256 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use

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

US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use

Code information

Lot Numbers: ANC1532¿ ANC1577¿ ANC1643¿ ANC1647¿ ANC1673¿ ANC2007¿ ANC2025¿ ANC2027¿ ANC2031¿ ANC2032¿ ANC2037¿

Distribution pattern

US Nationwide Distribution

device · product 2 of 7

AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.

Z-2284-2016
Recall number
Z-2284-2016
Initiated
June 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
471 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

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

US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

Code information

Lot Numbers: ANC1549¿ ANC1612¿ ANC1678¿ ANC1679¿ ANC1682¿ ANC2001¿ ANC2008¿ ANC2009¿ ANC2013¿ ANC2015¿ ANC2016¿ ANC2017¿ ANC2018¿ ANC2019¿ ANC2020¿ ANC2021¿

Distribution pattern

US Nationwide Distribution

device · product 3 of 7

Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1 Each} X-Large REF # 4000-08 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.

Z-2285-2016
Recall number
Z-2285-2016
Initiated
June 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
170 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

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

US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

Code information

Lot Numbers: ANC1487¿ ANC1665¿ ANC1672¿ ANC1683¿ ANC2002¿ ANC2003¿ ANC2010¿ ANC2011¿

Distribution pattern

US Nationwide Distribution

device · product 4 of 7

AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.

Z-2286-2016
Recall number
Z-2286-2016
Initiated
June 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
40 units (6-Pack)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

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

US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

Code information

Lot Numbers: ANR1064¿ ANR1066¿ ANR1068¿ ANR1069¿

Distribution pattern

US Nationwide Distribution

device · product 5 of 7

AnastoCiip Universal Clip Remover (1Each} REF# 4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.

Z-2287-2016
Recall number
Z-2287-2016
Initiated
June 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
39 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

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

US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

Code information

Lot Numbers: ANR1055¿ ANR1058¿ ANR1061¿ ANR1062¿ ANR1063¿ ANR1064¿ ANR1065¿ ANR1066¿ ANR1069¿

Distribution pattern

US Nationwide Distribution

device · product 6 of 7

AnastoCiip Universal Clip Remover (6 Pack} REF# e4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.

Z-2288-2016
Recall number
Z-2288-2016
Initiated
June 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
55 units (6 pack)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

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

US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

Code information

Lot Numbers: ANR1067¿ ANR1072¿ ANR1073¿ ANR1074¿

Distribution pattern

US Nationwide Distribution

device · product 7 of 7

AnastoCiip Universal Clip Remover (1Each} REF# e4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.

Z-2289-2016
Recall number
Z-2289-2016
Initiated
June 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
20 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

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

US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.

Code information

Lot Numbers: ANR1067¿ ANR1073¿

Distribution pattern

US Nationwide Distribution