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.
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 21
OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
These labels are deterministic app interpretations, not FDA categories.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Code information
ERT-6E12 ERT-7F02
Distribution pattern
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
device · product 2 of 21
OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
These labels are deterministic app interpretations, not FDA categories.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Code information
ERT-6H12
Distribution pattern
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
device · product 3 of 21
OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
These labels are deterministic app interpretations, not FDA categories.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Code information
ERT-6D06
Distribution pattern
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
device · product 4 of 21
OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
These labels are deterministic app interpretations, not FDA categories.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Code information
ERT-6F02
Distribution pattern
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
device · product 5 of 21
OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
These labels are deterministic app interpretations, not FDA categories.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Code information
ERT-6G08 ERT-6J03
Distribution pattern
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
device · product 6 of 21
OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
These labels are deterministic app interpretations, not FDA categories.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Code information
ERT-6H13
Distribution pattern
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
device · product 7 of 21
OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
These labels are deterministic app interpretations, not FDA categories.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Code information
ERT-6G10
Distribution pattern
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
device · product 8 of 21
OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
These labels are deterministic app interpretations, not FDA categories.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Code information
ERT-6K05 ERT-7J10
Distribution pattern
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
device · product 9 of 21
OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
These labels are deterministic app interpretations, not FDA categories.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Code information
ERT-6E05 ERT-6E06 ERT-7K02
Distribution pattern
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
device · product 10 of 21
OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
These labels are deterministic app interpretations, not FDA categories.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Code information
ERT-6J08 ERT-7J08 ERT-7K08
Distribution pattern
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
device · product 11 of 21
OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
These labels are deterministic app interpretations, not FDA categories.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Code information
ERT-6H14 ERT-6J11 ERT-7K09 ERT-7L13
Distribution pattern
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
device · product 12 of 21
OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
These labels are deterministic app interpretations, not FDA categories.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Code information
ERT-6D08 ERT-6J06 ERT-7L03 ERT-7L16
Distribution pattern
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
device · product 13 of 21
OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
These labels are deterministic app interpretations, not FDA categories.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Code information
ERT-6H01 ERT-6H15 ERT-7J02 ERT-7L02 ERT-7L10
Distribution pattern
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
device · product 14 of 21
OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
These labels are deterministic app interpretations, not FDA categories.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Code information
ERT-6G11
Distribution pattern
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
device · product 15 of 21
OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
These labels are deterministic app interpretations, not FDA categories.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Code information
ERT-6H16
Distribution pattern
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
device · product 16 of 21
OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
These labels are deterministic app interpretations, not FDA categories.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Code information
ERT-6E16 ERT-6F01
Distribution pattern
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
device · product 17 of 21
OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
These labels are deterministic app interpretations, not FDA categories.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Code information
ERT-6E14 ERT-6E17 ERT-8A02
Distribution pattern
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
device · product 18 of 21
OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
These labels are deterministic app interpretations, not FDA categories.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Code information
ERT-6E01 ERT-6I01 ERT-6J07
Distribution pattern
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
device · product 19 of 21
OviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
These labels are deterministic app interpretations, not FDA categories.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
These labels are deterministic app interpretations, not FDA categories.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Code information
ERT-6D03 ERT-6J05 ERT-6K01 ERT-7J06 ERT-7L15
Distribution pattern
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
device · product 21 of 21
OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
These labels are deterministic app interpretations, not FDA categories.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Code information
ERT-6H16 ERT-6K01 ERT-7J06 ERT-7L15
Distribution pattern
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
