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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96127

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

Open FDA event record

Event summary

Timeline bucket
December 20, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Ethicon, LLC

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

3 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 3

PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.

Z-1096-2025
Recall number
Z-1096-2025
Initiated
December 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Ethicon, LLC
Quantity
15,948

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
open seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach in sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

Code information

REF/UDI-DI-GTIN/Lot(expiration): EH7585H/10705031097254/103DQR(8/31/2029); 8706H/10705031019430/103E22(8/31/2029), 103EMJ(8/31/2029); 8833H/10705031021037/103HC4(8/31/2029); 8963H/10705031091931/103E8Z(8/31/2029); 8935H/10705031022089/103HBP(8/31/2029)

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and the countries of AT, AU, BE, CA, CH, CN, CZ, DE, DK, FI, FR, GB, HU, IE, JP, LU, NL, NO, PL, SE, SG, ZA.

device · product 2 of 3

PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical procedures.

Z-1097-2025
Recall number
Z-1097-2025
Initiated
December 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Ethicon, LLC
Quantity
78792

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
open seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach in sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

Code information

REF/UDI-DI-GTIN/Lot(expiration): F2416H/10705031238947/103E7C(8/31/2029); EH7808B/10705031239425/103E7A(8/31/2029); 661H/10705031007703/103GR7(8/31/2029), 103H5A(8/31/2029); 1669H/10705031001879/103GR2(8/31/2029), 103J14(8/31/2029); 644H/10705031089594/103EXA(8/31/2029); EH7827B/10705031239074/103EX9(8/31/2029); F3223BH/10705031240940/103EJH(8/31/2029); EH7797BH/10705031239487/103J2H(8/31/2029); 628H/10705031007000/1033PK(7/31/2029); 699G/10705031008625/102TMJ(7/31/2029); K872H/10705031044586/103DBT(8/31/2029); W723H/10705031202450/103G13(8/31/2029); 623H/10705031006898/10386S(8/31/2029); K833H/10705031044388/103K99(8/31/2029); 6664H/10705031089808/103G1B(8/31/2029); X425H/10705031057296/103H4B(8/31/2029); X872H/10705031058187/103DBT(8/31/2029); EH7491H/10705031096806/103D42(8/31/2029)

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and the countries of AT, AU, BE, CA, CH, CN, CZ, DE, DK, FI, FR, GB, HU, IE, JP, LU, NL, NO, PL, SE, SG, ZA.

device · product 3 of 3

ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US

Z-1098-2025
Recall number
Z-1098-2025
Initiated
December 20, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Ethicon, LLC
Quantity
48

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
open seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach in sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

Code information

REF/GTIN/Lot(expiration): W8003T/10705031231658/103GT2(8/31/2029)

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and the countries of AT, AU, BE, CA, CH, CN, CZ, DE, DK, FI, FR, GB, HU, IE, JP, LU, NL, NO, PL, SE, SG, ZA.