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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68124

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

Open FDA event record

Event summary

Timeline bucket
April 24, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Davol, Inc., Subs. C. R. Bard, 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

15 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 15

Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Z-1682-2014
Recall number
Z-1682-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Code information

HUXH0294, HUXL0314

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM

device · product 2 of 15

Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Z-1683-2014
Recall number
Z-1683-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Code information

Lot Number: HUXK1536

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM

device · product 3 of 15

Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Z-1684-2014
Recall number
Z-1684-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Code information

Lot Number: HUXK0073, HUXK1537

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM

device · product 4 of 15

Bard¿ Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Z-1685-2014
Recall number
Z-1685-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Code information

Lot Number: HUXK1539

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM

device · product 5 of 15

Bard¿ Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Z-1686-2014
Recall number
Z-1686-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Code information

Lot Number: HUXK1540

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM

device · product 6 of 15

Bard¿Ventralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Z-1687-2014
Recall number
Z-1687-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Code information

Lot Number: HUXK0900, HUXK0901, HUXL1148

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM

device · product 7 of 15

Bard¿ Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Z-1688-2014
Recall number
Z-1688-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Code information

Lot Number: HUYA1057

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM

device · product 8 of 15

Bard¿ Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Z-1689-2014
Recall number
Z-1689-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Code information

Lot Number: HUXH0535, HUXH0696, HUXK0747

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM

device · product 9 of 15

Bard¿ Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Z-1690-2014
Recall number
Z-1690-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Code information

Lot Number: HUXH0695

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM

device · product 10 of 15

Bard¿ Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Z-1691-2014
Recall number
Z-1691-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Code information

Lot Number: HUXH0694, HUXL1149, HUXL1150, HUYA1005

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM

device · product 11 of 15

Bard¿ Ventralight" ST Mesh with Echo PS" 6"x10" Reorder Number: 5955610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Z-1692-2014
Recall number
Z-1692-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Code information

Lot Number: HUXK0744, HUXL1004

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM

device · product 12 of 15

Bard¿ Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Z-1693-2014
Recall number
Z-1693-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Code information

Lot Number: HUXH0688, HUXK0743, HUXL0803, HUXL0804

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM

device · product 13 of 15

Bard¿ Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Z-1694-2014
Recall number
Z-1694-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Code information

Lot Number: HUXK0899

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM

device · product 14 of 15

Bard¿ Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Z-1695-2014
Recall number
Z-1695-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Code information

Lot Number: HUXK0058

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM

device · product 15 of 15

Bard¿ Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Z-1696-2014
Recall number
Z-1696-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
weak seal

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Code information

Lot Number: HUXH0691, HUXL0336, HUXL0495, HUXL0660, HUXL1006, HUXL1007, HUXL 1147

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM