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 27
Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
Lot - D7H0876X Expiration Date - 2022-08-31
Distribution pattern
US Nationwide distribution.
device · product 2 of 27
Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
Lot - A9J0018Y Expiration Date - 2024-08-31
Distribution pattern
US Nationwide distribution.
device · product 3 of 27
Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
Lot - A9J0075Y Expiration Date - 2024-08-31
Distribution pattern
US Nationwide distribution.
device · product 4 of 27
Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
Lot - A9H1170Y Expiration Date - 2024-07-31
Distribution pattern
US Nationwide distribution.
device · product 5 of 27
Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
Lot - A9H1065Y Expiration Date - 2024-07-31
Distribution pattern
US Nationwide distribution.
device · product 6 of 27
Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
Lot - A9J0006Y Expiration Date - 2024-08-31
Distribution pattern
US Nationwide distribution.
device · product 7 of 27
Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
Lot - D7H1048X Expiration Date - 2022-08-31
Distribution pattern
US Nationwide distribution.
device · product 8 of 27
Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
1) Lot - A9H1186Y Expiration Date - 2024-07-31; 2) Lot A9J0015Y Expiration Date - 2024-08-31
Distribution pattern
US Nationwide distribution.
device · product 9 of 27
Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
1) Lot - A9H0927Y Expiration Date - 2024-07-31; 2) Lot - A9H1187Y Expiration Date - 2024-07-31; 3) Lot - A9J0383Y Expiration Date - 2024-08-31; 4) Lot - A9J0428Y Expiration Date - 2024-08-31
Distribution pattern
US Nationwide distribution.
device · product 10 of 27
Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
1) Lot - A9H1189Y Expiration Date - 2024-07-31; 2) Lot - A9J0345Y Expiration Date - 2024-08-31
Distribution pattern
US Nationwide distribution.
device · product 11 of 27
Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
1) Lot - A9J0014Y Expiration Date - 2024-08-31; 2) Lot - A9J0193Y Expiration Date - 2024-08-31
Distribution pattern
US Nationwide distribution.
device · product 12 of 27
Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
Lot - A9K0004Y Expiration Date - 2024-09-30
Distribution pattern
US Nationwide distribution.
device · product 13 of 27
Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
Lot - A9J0421Y Expiration Date - 2024-08-31
Distribution pattern
US Nationwide distribution.
device · product 14 of 27
Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
Lot - A9J0053Y Expiration Date - 2024-08-31
Distribution pattern
US Nationwide distribution.
device · product 15 of 27
Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
Lot - D7H0794X Expiration Date - 2022-08-31
Distribution pattern
US Nationwide distribution.
device · product 16 of 27
Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
Lot - A9J0384Y Expiration Date - 2024-08-31
Distribution pattern
US Nationwide distribution.
device · product 17 of 27
Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
Lot - D7G0387X Expiration Date - 2022-07-31
Distribution pattern
US Nationwide distribution.
device · product 18 of 27
Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
Lot -D7H1126X Expiration Date - 2022-08-31
Distribution pattern
US Nationwide distribution.
device · product 19 of 27
Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
Lot -D7H1092X Expiration Date - 2022-08-31
Distribution pattern
US Nationwide distribution.
device · product 20 of 27
Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
Lot -D7H1214X Expiration Date - 2022-08-31
Distribution pattern
US Nationwide distribution.
device · product 21 of 27
Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
Lot -A9H0847FY Expiration Date - 2024-07-31
Distribution pattern
US Nationwide distribution.
device · product 22 of 27
Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
1) Lot -D7G2298X Expiration Date - 2022-07-31; 2) Lot - D7H0091X Expiration Date - 2022-08-31
Distribution pattern
US Nationwide distribution.
device · product 23 of 27
Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
Lot - D7H0946X Expiration Date - 2022-08-31
Distribution pattern
US Nationwide distribution.
device · product 24 of 27
Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
1) Lot - D7G2301X Expiration Date - 2022-07-31; 2) Lot - D7H0092X Expiration Date - 2022-08-31
Distribution pattern
US Nationwide distribution.
device · product 25 of 27
Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information
Lot - D7H0796X Expiration Date - 2022-08-31
Distribution pattern
US Nationwide distribution.
device · product 26 of 27
Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
