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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91324

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

Open FDA event record

Event summary

Timeline bucket
December 02, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Covidien, LP

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

11 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 11

Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM C12 (3) 88861749-24 DERMALON* 5-0 BLU 45CM P13 (4) 88861756-11 DERMALON* 6-0 BLU 45CM C13 (5) 88861757-41 DERMALON* 3-0 BLU 75CM C13

Z-1172-2023
Recall number
Z-1172-2023
Initiated
December 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Covidien, LP
Quantity
9606

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterile Barrier Breach

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

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Code information

GTIN: 10884521070981 20884521070988 20884521070797 10884521070790 20884521070797 20884521070698 10884521070691 20884521070834 10884521070806 20884521070803 20884521070698 10884521070691 20884521070797 Lot # (1) D2B0701Y, D2E3000Y (2) D1M2315FY, D1M2326FY,D2F1873FY (3) D2B2781FY (4) D2B1309FY (5) D1J0777FY

Distribution pattern

US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Georgia Germany Ghana Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy JAPAN Jordan Kazakhstan Kenya Korea, Republic Of Kosovo Kuwait Latvia Lebanon Lithuania Macao Malaysia Malta Mauritius Mexico Moldova, Republic Of Morocco Myanmar Namibia Netherlands New Zealand North Macedonia Norway Pakistan Panama Paraguay Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam Zimbabwe

device · product 2 of 11

Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 SILK 18 DS18 (3) S683GX 4-0 SILK 18 DS18 (4)S697GX 6-0 NYLON 18 DSM11 (5)S697GX 6-0 NYLON 18 DSM11 (6)S913BX 5-0 NYLON 10 DS12 (7)S931BX 4-0 NYLON 10 DS12

Z-1173-2023
Recall number
Z-1173-2023
Initiated
December 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Covidien, LP
Quantity
12732 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterile Barrier Breach

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

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Code information

GTIN: 20612479214235, 20612479214419, 20612479214495, 20612479213283, 20612479214235, 20612479213269 Lot # (1) D1L0912FY (2) D1G1840FY (3) D2B1262FY (4) D1M2377FY (5) D1M2847FY (6) D2D1386FY (7) D2B0756FY

Distribution pattern

US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Georgia Germany Ghana Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy JAPAN Jordan Kazakhstan Kenya Korea, Republic Of Kosovo Kuwait Latvia Lebanon Lithuania Macao Malaysia Malta Mauritius Mexico Moldova, Republic Of Morocco Myanmar Namibia Netherlands New Zealand North Macedonia Norway Pakistan Panama Paraguay Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam Zimbabwe

device · product 3 of 11

Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-12 MONOSOF* 2-0 BLK 100CM GCC90 CN-793 MONOSOF* 1 BLK 100CM GCC90 X36 CN-793-12 MONOSOF* 1 BLK 100CM GCC90X12 CN-830-L MONOSOF* 1 BLK 150CM LP GS25 N-2781K MONOSOF* 5-0 BLK 45CM SS24 DAX12 SN-1647 MONOSOF* 7-0 BLK 45CM P16 X36 SN-1647G MONOSOF* 7-0 BLK 45CM P16 X12 SN-247 MONOSOF* 3-0 BLK 90CM C23 X36 SN-3686 MONOSOF* 7-0 BLK 45CM P10 X12 SN-3695 MONOSOF* 5-0 BLK 45CM P10 X12 SN-3697 MONOSOF* 6-0 BLK 45CM P10 X12 SN-3965 MONOSOF* 5-0 BLK 45CM PC11 X12 SN-5660G MONOSOF* 6-0 BLK 45CM P24 X12 SN-5665G MONOSOF* 6-0 BLK 45CM P12 X12 SN-5690G MONOSOF* 5-0 CLR 45CM P13 X12 SN-5691 MONOSOF* 4-0 CLR 45CM P13 X36 SN-5694 MONOSOF* 4-0 BLK 45CM P11 X36 SN-5696 MONOSOF* 6-0 BLK 45CM P13 X36 SN-5697 MONOSOF* 6-0 BLK 45CM P10 X36 SN-5767G MONOSOF* 6-0 BLK 45CM P11 X12 SN-630 MONOSOF* 4-0 BLK 75CM C22 X36 SN-643 MONOSOF* 5-0 BLK 75CM C13 X36 SN-667G MONOSOF* 6-0 BLK 45CM C1 X12 SN-694 MONOSOF* 2-0 BLK 90CM C18 X36 SN-871 MONOSOF* 5-0 BLK 45CM C1 X36 SN-872 MONOSOF* 4-0 BLK 45CM C1 X36 SUT GNJ-283 MONOSOF 2/0 BLK ST DA 90CM SUT N-59 MONOSOF 2-0 BLK 6X45CM PCT

Z-1174-2023
Recall number
Z-1174-2023
Initiated
December 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Covidien, LP
Quantity
54288 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterile Barrier Breach

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

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Code information

GTIN: 20884521075105, 20884521075235, 10884521075238, 20884521075143, 10884521635395, 20884521077857, 20884521075372, 20884521078090, 20884521077994, 20884521079073, 10884521080348, 20884521080345, 20884521080321, 10884521080324, 10884521078758, 20884521078755, 20884521078182, 20884521078045, 20884521075129, 10884521635371, 20884521127675, 20884521079844, 20884521079028, 20884521079325, 10884521079328, 20884521079097, 10884521079090, 20884521079202, 20884521079448, 20884521076829, 10884521075146, 20884521080093, 20884521079042, A8845210765103, 20884521076812, 20884521077987, 20884521079134, 10884521079137, Model # Lot # CN-724 D1B2528Y CN-791 D1L1776Y CN-79112 D1L1776Y CN-793 D1D2772Y D2B2754Y CN-79312 D1D2772Y CN-830-L D1D2705Y N-2781K D1L2330Y SN-1647 D2E2028FY SN-1647G D2B2227FY SN-247 D1D3222FY D2B0043FY SN-3686 D2E2761FY D2F0402FY SN-3695 D1G0954FY D1L0957FY D2C1333FY D2E2762FY SN-3697 D1L1710FY D2C1211FY SN-3965 D1E1222Y SN-5660G D1L0922FY SN-5665G D1L0774FY SN-5690G D1M1283FY SN-5691 D2D0703FY SN-5694 D1J1230FY SN-5696 D1M2419FY SN-5697 D2F0399FY SN-5767G D2A0554FY SN-630 D1M1286FY SN-643 D2B0369FY SN-667G D1L2502FY SN-694 D2C0324FY SN-871 D1K3362FY SN-872 D1K2654FY D1M2450FY GNJ-283 D1E0555Y D1E0750Y N-59 D2D2350Y

Distribution pattern

US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Georgia Germany Ghana Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy JAPAN Jordan Kazakhstan Kenya Korea, Republic Of Kosovo Kuwait Latvia Lebanon Lithuania Macao Malaysia Malta Mauritius Mexico Moldova, Republic Of Morocco Myanmar Namibia Netherlands New Zealand North Macedonia Norway Pakistan Panama Paraguay Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam Zimbabwe

device · product 4 of 11

Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886 4400-13 NOVAFIL 6-0 BLU 45CM SBE2 8886 4400-23 NOVAFIL 5-0 BLU 45CM SBE2 8886 440123 NOVAFIL 5-0 BLU 45CM SBE3 8886 4402-33 NOVAFIL 4-0 BLU 45CM SBE4 8886 4403-33 NOVAFIL 4-0 BLU 45CM SBE6 8886 4410-13 NOVAFIL 6-0 BLU 45CM P10 8886 4410-03 NOVAFIL 7-0 BLU 45CM P10 8886 4422-43 NOVAFIL 3-0 BLU 45CM C14 8886 4424-51 NOVAFIL 2-0 BLU 75CM C16 8886 4450-41 NOVAFIL 3-0 BLU 75CM V26 8886 4452-51 NOVAFIL 2-0 BLU 75CM V20 8886 4459-61 NOVAFIL 0 BLU 75CM GS22 8886 4470-81 NOVAFIL* 2 BLU 150CM GS26 8886 4582-53 NOVAFIL* 2-0 BLU 75CM P14 SPB-1213G NOVAFIL* 6-0 BLU 45CM P13X12 SPB-1233G NOVAFIL* 4-0 BLU 45CM P13X12 SPB-1623G NOVAFIL* 5-0 BLU 45CM P12X12 SPB-5142G NOVAFIL* 5-0 BLU 45CM P11X12 SPB-5143G NOVAFIL* 4-0 BLU 45CM P11X12 SUT SPB-5223G NOVAFIL 5-0 BLU 45CM P13 SPB-5433G NOVAFIL* 4-0 CLR 45CM P24X12 SPB-5633G NOVAFIL* 4-0 BLU 45CM P12X12

Z-1175-2023
Recall number
Z-1175-2023
Initiated
December 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Covidien, LP
Quantity
48492 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterile Barrier Breach

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

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Code information

GTIN 20884521100821, 20884521100098, 10884521100091, 10884521100299, 20884521100296, 20884521099910, 20884521100814, 20884521100791, 20884521100593, 20884521099965, 20884521099477, 20884521100760, 20884521118345, 10884521118348, 20884521099682, 20884521118406, 20884521099699, 20884521100838, 20884521099699, 20884521118390, 10884521118393, 20884521100890, 10884521100893, 20884521099569, 20884521100692, 20884521100074, 20884521099583, 20884521100876, 20884521100777. Model # Lot #: 8886400241 D1G1762FY, 8886440013 D2A0461Y, 8886440023 D1M0797Y, 8886440123 D1L3389Y, 8886440233 D2A0529Y, 8886440333 D2C0582Y, 8886441003 D1M1007FY, D1M2364FY 8886441013 D1M1007FY D1M2364FY, 8886441003 D1M0369FY D1M0796FY, 8886442243 D1D2485FY, 8886442451 D1E1240FY, 8886445041 D2B2109Y, 8886445251 D1D0295Y, D1E0843Y, 8886445961 D1D0529Y, 8886447081 D1D3190Y, 8886458253 D2B1686FY, SPB1213G D1L0169FY, D2B0773FY D2C0769FY, SPB1233G D2E0961FY, SPB1623G D1D2709FY, SPB5142G D1B2811FY, SPB5143G D1D2674FY, SPB5223G D1M1024FY, SPB5433G D2C1970FY, SPB5633G D2A0500FY, SPB-5223G D1M1024FY

Distribution pattern

US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Georgia Germany Ghana Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy JAPAN Jordan Kazakhstan Kenya Korea, Republic Of Kosovo Kuwait Latvia Lebanon Lithuania Macao Malaysia Malta Mauritius Mexico Moldova, Republic Of Morocco Myanmar Namibia Netherlands New Zealand North Macedonia Norway Pakistan Panama Paraguay Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam Zimbabwe

device · product 5 of 11

Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36 CS490 CS-562 SOFSILK* 2-0 BLK 75CM GS23 X36 CS562 GS-823 SOFSILK* 2-0 BLK 75CM V30 X36 GS823 GS-835 SOFSILK* 1 BLK 75CM V20 X36 GS835 S-1172 SOFSILK* 6-0 BLK 45CM C1 X36 S1172 S-1173 SOFSILK* 5-0 BLK 45CM C1 X36 S1173 S-1174 SOFSILK* 4-0 BLK 45CM C1 X36 S1174 S-1750K SOFSILK* 6-0 BLK 45CM HE1 DAX12 S1750K S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S176 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S176 S-1768K SOFSILK* 7-0 BLK 45CM HE6 DAX12 S1768K S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S182 S-183 SOFSILK* 4-0 BLK 12X45CM PCT X36 S183 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S184 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S185 S-187 SOFSILK* 1 BLK 6X45CM PCT X36 S187 S-206 SOFSILK* 2 BLK 100CM STDLTH X36 S206 S-243 SOFSILK* 4-0 BLK 12X60CM PCT X36 S243 S-244 SOFSILK* 3-0 BLK 12X60CM PCT X36 S244 S-245 SOFSILK* 2-0 BLK 12X60CM PCT X36 S245 S-246 SOFSILK* 0 BLK 6X60CM PCT X36 S246 S-2782K SOFSILK* 4-0 WHI 45CM SS24 DA S2782K S-303 SOFSILK* 4-0 BLK 12X75CM PCT X36 S303 S-304 SOFSILK* 3-0 BLK 12X75CM PCT X36 S304 S-305 SOFSILK* 2-0 BLK 12X75CM PCT X36 S305 S-316 SOFSILK* 0 BLK 12X75CM PCT X24 S316 S-317 SOFSILK* 1 BLK 12X75CM PCT X24 S317 S-318 SOFSILK* 2 BLK 12X75CM PCT X24 S318 S-346 SOFSILK* 0 BLK 12X60CM PCT X24 S346 S-605 SOFSILK* 2-0 BLK 2X150CM PCT X36 S605 S-607 SOFSILK* 1 BLK 2X150CM PCT X36 S607 S-608 SOFSILK* 2 BLK 2X150CM PCT X36 S608 SS-523 SOFSILK* 2-0 BLK 75CM SC1 X36 SS523 SS-525 SOFSILK* 1 BLK 75CM SC1 X36 SS525 SS-5641 SOFSILK* 4-0 BLK 45CM P13 X36 SS5641 SS-5641G SOFSILK* 4-0 BLK 45CM P13 X12 SS5641G SS-5678 SOFSILK* 5-0 BLK 45CM P11 X36 SS5678 SS-5684 SOFSILK* 3-0 BLK 45CM P14 X36 SS5684 SS-623 SOFSILK* 2-0 BLK 75CM SC2 X36 SS623 SS-645 SOFSILK* 4-0 BLK 75CM C12 X36 SS645 SS-653 SOFSILK* 4-0 BLK 75CM C13 X36 SS653 SS-673 SOFSILK* 5-0 BLK 75CM C12 X36 SS673 SS-683G SOFSILK* 4-0 BLK 45CM C13 X12 SS683G SS-685G SOFSILK* 2-0 BLK 45CM C15 X12 SS685G SS-686 SOFSILK* 4-0 BLK 45CM C12 X12 SS686 SS-689 SOFSILK* 1 BLK 75CM C16 X36 SS689 SS-745 SOFSILK* 3-0 BLK 75CM C12 X36 SS745 SS-786 SOFSILK* 0 BLK 75CM C14 X36 SS786 SS-787 SOFSILK* 1 BLK 75CM C14 X36 SS787 VS-533 SOFSILK* 2-0 BLK 90CM V20 DAX36 VS533 VS-845 SOFSILK* 1 BLK 75CM V26 X36 VS845 VS-870 SOFSILK* 5-0 BLK 75CM CV23 X36 VS870 VS-871 SOFSILK* 4-0 BLK 75CM CV23 X36 VS871 SOFSILK 4-0 30 BK CV-23 VS871-2 VS8712 VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36 VS872 SOFSILK 3-0 30 BK CV-23 VS872-2 VS8722 VS-882 SOFSILK* 3-0 BLK 75CM CV15 X36 VS882 SOFSILK 5-0 30 BK CV-11 VS890-2 VS8902 XX-5278 SOFSILK* 3-0 BLK 150CM PCT X36 XX5278 XX-5280 SOFSILK* 0 BLK 150CM PCT X36 XX5280 XX-5281 SOFSILK* 1 BLK 150CM PCT X36 XX5281 XX-5284 SOFSILK* 4 BLK 150CM PCT X36 XX5284

Z-1176-2023
Recall number
Z-1176-2023
Initiated
December 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Covidien, LP
Quantity
271800 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterile Barrier Breach

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

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Code information

GTIN: 20884521086781, 20884521758060, 20884521088136, 20884521088525, 20884521087504, 20884521085289, 20884521087672, 20884521087481, 20884521090566, 20884521086712, 20612479214235, 10884521084698, 20884521084695, 20884521085166, 20884521087580, 10884521087583, 20884521089256, 20884521088532, 20884521087719, 20884521090160, 10884521090163, 20884521087900, 20612479214419, 20884521083629, 20884521085944, 20884521086668, 20884521087399, 10884521086142, 20884521086149, 10884521086623, 20884521086620, 20884521106106, 20884521085968, 20884521086484, 20884521086491, 10884521086494, 20884521088624, 10884521086661, 20884521086170, 20884521085951, 10884521086463, 20884521086460, 20884521086187, 10884521085787, 20884521085784, 20884521085517, 20884521090184, 20612479214495, 20884521090153, 20884521086651, 10884521085510, 20884521088464, 20884521088129, 20884521086194, 10884521086197, 20884521086552, 10884521087484, 20884521085982, 10884521085985, 20884521086477, 20884521106021, 20884521106052, 20884521757926, 10884521083622, 20612479213283, 20884521090115, 10884521090118, 20884521085746, 20884521087429, 20884521086774, 20884521085975, 20884521088143, 20884521086705, 20884521085470, 20884521085500, 20884521084671, 10884521084674, 20884521758039, 20612479213269, 10884521085169, 20884521086514, 20884521086200, 20884521106045, 20884521085739, 20884521086422. Model Number Lot # CS211 D1L1576Y D2B0747Y CS490 D2C2519Y CS562 D1G1928Y GS823 D1K1923Y D2D1396Y GS835 D1E1757Y S1172 D2C2304Y S1173 D2C2305Y D2E1385Y S1174 D1M1794FY D1M2954FY D1M2984FY S1750K D2E2348Y S176 D2B1886Y S176 D2C1977Y S1768K D1M1759Y D2B2217Y S182 D1L1613Y D2B0177Y S183 D1M1421Y D2E1280Y S184 D1L3136Y D1M2895Y D2D0954Y D2D0964Y D2D0967Y D2D0972Y S185 D2B2785Y D2B2877Y D2B2878Y D2C1421Y D2D0957Y D2D0968Y D2D0971Y D2D0984Y D2D0985Y D2E2680Y D2E2767Y D2E2769Y S187 D2A1585Y S206 D1L2658Y D1M2896Y D2A1586Y S243 D1M1020Y D2D2348Y S244 D1M1590Y S245 D2A0559Y D2C2036Y D2C2162Y D2D1871Y S246 D2E1375Y S2782K D2F0062Y S303 D1M1424Y D2C1472Y D2D1872Y D2D2120Y D2E1496Y S304 D2B0173Y D2C2163Y D2C2805Y D2D1991Y D2E1484Y S305 D1L3282Y D1L3459Y D2C1280Y D2C1281Y D2C1479Y D2D0959Y D2E0907Y D2E2768Y D2E2772Y S316 D1L3311Y D1M0530Y D2A0555Y D2A0557Y D2A0558Y D2A0866Y D2C2806Y D2D2434Y D2D2436Y S317 D2D2087Y D2E0587Y S318 D1M0153Y D2A1677Y S346 D2A0867Y D2B1884Y S605 D1L2686Y D2B2244Y S607 D1M2899Y S608 D1L1617Y D1L1619Y D1L1622Y D1M0173Y D1M0635Y D1M0655Y D2E1210Y SS523 D2C1971Y SS525 D1G1346Y SS5641 D2B2181FY SS5641G D1D2533FY SS5678 D1L2430FY SS5684 D2B1970FY SS623 D1G0960Y D2A1069Y SS645 D1K2457FY D1L3151FY D1M2526FY D1M2531FY SS653 D1E2737FY SS673 D1L0164FY SS683G D1L0794FY SS685G D2A0503FY SS686 D1E0201FY SS689 D2C0024FY SS745 D1M2971FY SS786 D1E1220FY SS787 D1L0032FY VS533 D1M0598Y VS845 D2B1779Y VS870 D1M2873Y VS871 D1L0602Y VS8712 D2C3153Y VS872 D1M1837Y D2C2945Y VS8722 D1D3187Y D1M1292Y VS882 D1G1139Y VS8902 D2B0364Y XX5278 D2B0174Y XX5280 D2E1482Y XX5281 D2B0175Y XX5284 D1L2691Y

Distribution pattern

US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Georgia Germany Ghana Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy JAPAN Jordan Kazakhstan Kenya Korea, Republic Of Kosovo Kuwait Latvia Lebanon Lithuania Macao Malaysia Malta Mauritius Mexico Moldova, Republic Of Morocco Myanmar Namibia Netherlands New Zealand North Macedonia Norway Pakistan Panama Paraguay Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam Zimbabwe

device · product 6 of 11

Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA

Z-1177-2023
Recall number
Z-1177-2023
Initiated
December 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Covidien, LP
Quantity
2070 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterile Barrier Breach

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

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Code information

GTIN: 20884521064710, 10884521064713 Model # Lot # D-1764K D1L2420Y D1L2428Y D1M2883Y

Distribution pattern

US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Georgia Germany Ghana Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy JAPAN Jordan Kazakhstan Kenya Korea, Republic Of Kosovo Kuwait Latvia Lebanon Lithuania Macao Malaysia Malta Mauritius Mexico Moldova, Republic Of Morocco Myanmar Namibia Netherlands New Zealand North Macedonia Norway Pakistan Panama Paraguay Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam Zimbabwe

device · product 7 of 11

Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-61 SURGILON* 0 BLK 7X75CM PCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT 88861932-51 SURGILON* 2-0 BLK 75CM GS10 88861971-71 SURGILON* 1 BLK 75CM GS21 88861985-71 SURGILON* 1 BLK 75CM SC1X36 SBS-1884G SURGILON* 4-0 WHI 45CM P12X12 SBS-1928G SURGILON* 5-0 BLK 45CM P13X12

Z-1178-2023
Recall number
Z-1178-2023
Initiated
December 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Covidien, LP
Quantity
87708 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterile Barrier Breach

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

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Code information

GTIN: 20884521073996, 20884521076652, 10884521072183, 20884521072180, 10884521071223, 20884521071220, 10884521071797, 20884521071794, 20884521071763, 20884521071787, 20884521071749, 10884521073838, 20884521073835, 20884521076669, 10884521076662, 10884521071766, 20884521071725, 10884521071513, 20884521071510. Model Number Lot # 8886188351 D1K1677FY 8886191571 D2C3242Y 8886191931 D2B2243Y 8886191941 D1M2553Y D1M2561Y D2B0169Y 8886191951 D1M0915Y D2A0560Y D2B1245Y D2B1537Y D2B2751Y D2C0267Y D2C0907Y D2C1101Y D2D2347Y D2D2437Y D2D2506Y D2D2510Y D2E0905Y 8886191961 D1M1423Y D2A0861Y D2A0865Y D2A1709Y D2B1349Y D2B1350Y D2B2727Y 8886191971 D1M0640Y D1M1494Y D2C0962Y 8886193251 D1G1867Y 8886197171 D2B0290Y D2B0445Y D2B0476Y 8886198571 D1E0626Y SBS1884G D1E1212FY SBS1928G D2B0707FY D2C3247FY

Distribution pattern

US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Georgia Germany Ghana Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy JAPAN Jordan Kazakhstan Kenya Korea, Republic Of Kosovo Kuwait Latvia Lebanon Lithuania Macao Malaysia Malta Mauritius Mexico Moldova, Republic Of Morocco Myanmar Namibia Netherlands New Zealand North Macedonia Norway Pakistan Panama Paraguay Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam Zimbabwe

device · product 8 of 11

Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP-543 SURGIPRO* 2-0 BLU 120CM V20 DA

Z-1179-2023
Recall number
Z-1179-2023
Initiated
December 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Covidien, LP
Quantity
8604 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterile Barrier Breach

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

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Code information

GTIN: 20884521037868, 20884521036519, 20884523004387, 20884521036540, 20884521037868. Model Number Lot # CP535 D2C1521Y D2E1342Y D2E1580Y D2E2678Y D2E2679Y D2F0509Y CP824 D2D0251Y CP825 D2C3234Y VP543 D2B1270Y D2D1493Y D2E1389Y

Distribution pattern

US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Georgia Germany Ghana Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy JAPAN Jordan Kazakhstan Kenya Korea, Republic Of Kosovo Kuwait Latvia Lebanon Lithuania Macao Malaysia Malta Mauritius Mexico Moldova, Republic Of Morocco Myanmar Namibia Netherlands New Zealand North Macedonia Norway Pakistan Panama Paraguay Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam Zimbabwe

device · product 9 of 11

Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X SURGIPRO II 4-0 90CM KV5 DA7P VP435X VP-541X SURGIPRO*II 4-0 BLU 120CM V20DA VP541X VP-542-X SURGIPRO II 3-0 BLU 120CM V20DA VP542X VP-735-X SURGIPRO*II 7-0 60CM MV1758DA VP735X VP735X-12 SURGIPRO*II 7-0 60CM MV1758 DA VP735X12 VP-738-X SURGIPRO*II 8-0BLU 60CM CV351DA VP738X VP-744-X SURGIPRO*II 8-0 45CM MV1758DA VP744X VP-745-X SURGIPRO*II 8-0 60CM MV1758DA VP745X VP-747-X SURGIPRO*II 7-0 75CM MV1758DA VP747X VP-853 SURGIPRO* 2-0 BLU 120CM V26 DA VP853 VP-875-X SURGIPRO*II 7-0 75CM MV1759DA VP875X VP-900-X SURGIPRO*II 8-0 45CM MV1355DA VP900X VP-902-X SURGIPRO*II 8-0 60CM MV1355DA VP902X VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X SURGIPRO II 4-0 90CM KV5 DA7P VP435X VP-541X SURGIPRO*II 4-0 BLU 120CM V20DA VP541X VP-542-X SURGIPRO II 3-0 BLU 120CM V20DA VP542X VP-735-X SURGIPRO*II 7-0 60CM MV1758DA VP735X VP735X-12 SURGIPRO*II 7-0 60CM MV1758 DA VP735X12 VP-738-X SURGIPRO*II 8-0BLU 60CM CV351DA VP738X VP-744-X SURGIPRO*II 8-0 45CM MV1758DA VP744X VP-745-X SURGIPRO*II 8-0 60CM MV1758DA VP745X VP-747-X SURGIPRO*II 7-0 75CM MV1758DA VP747X VP-853 SURGIPRO* 2-0 BLU 120CM V26 DA VP853 VP-875-X SURGIPRO*II 7-0 75CM MV1759DA VP875X VP-900-X SURGIPRO*II 8-0 45CM MV1355DA VP900X VP-902-X SURGIPRO*II 8-0 60CM MV1355DA VP902X12 VP-904-X SURGIPRO*II 7-0 BLU 60CM MV1355 VP904X VPF-735-X SURGIPRO*II 7-0 60CM MVF1758DA VPF735X XX-3300 SURGIPRO* II 5-0 BLU 60CM CV1DA XX3300 XX-5224 SURGIPRO*II 5-0 BLU 90CM CV25DA XX5224

Z-1180-2023
Recall number
Z-1180-2023
Initiated
December 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Covidien, LP
Quantity
322152 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterile Barrier Breach

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

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Code information

GTIN: GTIN 20884521039534 20884521038902 20884521039596 20884521038810 10884521038813 20884521039565 10884521039568 20884521039466 10884521039469 10884521640061 20884521038940 10884521038943 20884521038841 20884521038896 10884521039599 10884521038905 10884521037717 20884521037714 10884521037748 20884521037745 10884521640276 20884521039404 20884521037844 20884521037851 20884521758558 20884521758664 10884521039537 10884521038844 Model Number Lot # VP421X D2C1147Y VP435X D2C1148Y D2D0080Y D2D0081Y D2D1507Y D2E1343Y VP541X D2E0506Y D2E0507Y VP542X D2E0749Y D2E0750Y VP735X D0M2060Y D0M2061Y D1A0234Y D1A0419Y D1A0420Y D1A0474Y D1A0479Y D1A0480Y D1A0499Y D1A0960Y D1A1636Y D1B0024Y D1B0513Y D1B1462Y D1B2759Y D1B2760Y D1B2784Y D1B2785Y D1G2405Y D1G2406Y D1H1658Y D1H1945Y D1H1971Y D1H2033Y D1H2104Y D1H2105Y D1H2106Y D1H2107Y D1J0372Y D1J0374Y D1J0375Y D1J0376Y D1J0591Y D1J1260Y D1J1679Y D1J1923Y D1J1928Y D1J1929Y D1J2885Y D1K2644Y D1L0457Y D1L3332Y D1M0869Y D1M0870Y D1M0963Y D1M1464Y D2B0362Y D2C1982Y D2C2348Y D2D0155Y D2D0156Y D2D0166Y D2D0942Y D2D2100Y D2E0165Y D2E0173Y D2E0175Y D2E1035Y D2E1073Y D2E1536Y D2E2752Y D2F1973Y D2F1974Y D2F1975Y VP735X12 D1B2760Y D2D0941Y VP738X D1G0407Y D2C1983Y D2F0494Y D2F0495Y D2F0496Y VP744X D1G0408Y VP744X D1L0327Y VP745X D0M1980Y D1A1635Y D1G1298Y D1H2487Y D1H2488Y D1J0373Y D1J1210Y D1J2362Y D1J2364Y D1J2366Y D1J2541Y D1J2543Y D1K0073Y D1K2317Y D1K2318Y D1K2319Y D1K2326Y D1K2328Y D1K2329Y D1K2642Y D1K2646Y D1K2647Y D1K2648Y D2B0470Y D2B1158Y D2C1984Y D2D0944Y D2D0945Y D2E1923Y D2F0798Y D2F0799Y VP747X D1C0229Y D1C0230Y D1C1787Y D1C1849Y D1G0404Y D1G0405Y D1G2408Y D1M1397Y D1M1465Y D2A0334Y D2D0158Y D2E1074Y VP853 D2D0641Y VP875X D1A1244Y D1E0734Y D1H0909Y D1J1926Y D1K2643Y D1L0605Y D1L2328Y D1M2164Y D1M2165Y D2C0956Y D2E1883Y D2F0936Y VP900X D0K3052Y D1H1373Y D1H1374Y D1H1375Y D1H1457Y D1L0158Y D1L0159Y D1L1321Y D1L2329Y D1L2617Y D1L2618Y D1M1597Y D2A0335Y D2C1926Y D2F0041Y D2F0042Y VP902X D1A1236Y D1A1238Y D1A1240Y D1A1242Y D1A1526Y D1B1245Y D1B1246Y D1B1265Y D1B1954Y D1B2137Y D1B2688Y D1C0681Y D1C1270Y D1C2801Y D1C2817Y D1D0141Y D1D0411Y D1D0687Y D1D1498Y D1D1499Y D1D1570Y D1D2580Y D1D2693Y D1D3578Y D1D3629Y D1E0582Y D1E0583Y D1E2328Y D1E3445Y D1F0032Y D1F0519Y D1F0521Y D1F1704Y D1F2371Y D1G3162Y D1H0384Y D1H0411Y D1H0899Y D1H0901Y D1H0902Y D1H0904Y D1H0905Y D1H0906Y D1J0586Y D1J0597Y D1J0598Y D1J0599Y D1J0993Y D1J1258Y D1J1623Y D1J1832Y D1J2361Y D1J2365Y D1J2542Y D1K0111Y D1K0519Y D1K2349Y D1K2350Y D1K2416Y D1K2417Y D1K2418Y D1K2419Y D1K2573Y D1K2576Y D1K2632Y D1K2645Y D1L3382Y D1L3383Y D1M0015Y D1M0016Y D1M0151Y D1M0166Y D1M0169Y D1M0299Y D1M0300Y D1M1031Y D1M2836Y D1M2839Y D1M2841Y D2A0336Y D2A0338Y D2A1717Y D2A1718Y D2B0361Y D2B0469Y D2B1062Y D2B1063Y D2B1255Y D2B1257Y D2C0951Y D2C0952Y D2C1330Y D2C1331Y D2C1927Y D2C1928Y D2C2398Y D2C2399Y D2C2400Y D2C2401Y D2C2509Y D2C2738Y D2D0097Y D2D0098Y D2D0099Y D2D0162Y D2D0163Y D2D0167Y D2D0168Y D2D0169Y D2D2005Y D2E0167Y D2E0168Y D2E0169Y D2E0170Y D2E0171Y D2E0172Y D2E0174Y D2E1528Y D2E1529Y D2E1531Y D2E1845Y D2E1884Y D2E1885Y D2E1922Y D2E2097Y D2G0697Y VP902X12 D2C1928Y D2G0697Y VP904X D0M1981Y D1B0657Y D1C1118Y D1D2622Y D1G1296Y D1G1299Y D1G1999Y D1J2884Y D1M0345Y D1M2834Y D2A0337Y D2B1159Y D2E1078Y VPF735X D1G1297Y D1K0520Y D1M1046Y D1M1557Y D2E1079Y XX3300 D2F2287Y XX5224 D2D0804Y

Distribution pattern

US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Georgia Germany Ghana Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy JAPAN Jordan Kazakhstan Kenya Korea, Republic Of Kosovo Kuwait Latvia Lebanon Lithuania Macao Malaysia Malta Mauritius Mexico Moldova, Republic Of Morocco Myanmar Namibia Netherlands New Zealand North Macedonia Norway Pakistan Panama Paraguay Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam Zimbabwe

device · product 10 of 11

Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA 88863012-61 TICRON* 0 BLU 90CM C16 X36 88863015-61 TICRON* 0 BLU 120CM V20X36 88863017-51 TICRON* 2-0 BLU 120CM SKX36 88863026-71 TICRON* 1 BLU 75CM HOS12X36 88863035-51 TICRON 2-0 BLU 105CM CV305DA 88863047-41 TICRON* 3-0 BLU 45CM C13X36 88863048-51 TICRON* 2-0 BLU 75CM C13X36 88863050-61 TICRON* 0 BLU 75CM C14 X36 88863054-51 TICRON* 2-0 BLU 75CM C17X36 88863056-89 TICRON* 5 BLU 45CM GS18X12 88863059-53 TICRON* 2-0 BLU 45CM P24X12 88863070-51 TICRON* 2-0 BLU 75CM C15X36 88863088-51 TICRON* 2-0 BLU 75CM Y5X36 88863090-51 TICRON 2-0 BLU 75CM GS21X36 88863092-71 TICRON* 1 BLU 75CM KV37X36 88863109-43 TICRON* 3-0 BLU 45CM P22X12 88863111-79 TICRON* 5 BLU 75CM HGS21X36 88863119-61 TICRON* 0 BLU 75CM KV34X36 88863154-09 TICRON* 4 BLU 75CM GS11X36 88863159-31 TICRON* 4-0 BLU 90CM KV5DA 88863160-41 TICRON* 3-0 BLU 90CM Y31DA 88863163-61 TICRON* 0 BLU 75CM SC1 X36 88863185-41 TICRON* 3-0 BLU 75CM CV305 88863186-41 TICRON* 3-0 BLU 75CM CV331 88863212-51 TICRON* 2-0 BLU 90CM Y5DA7P 88863226-41 TICRON* 3-0 BLU 60CM CV330DA 88863280-21 TICRON* 5-0 BLU 75CM CV301DA 88863280-31 TICRON* 4-0 BLU 75CM CV301DA 88863309-71 TICRON* 1 BLU 75CM GS11X36 88863369-31 TICRON* 4-0 BLU 90CM CV316DA 88863393-51 TICRON* 2-0 BLU 90CM CV300DA CD-3123K TICRON* 5-0 WHI 45CM SS24 DA

Z-1181-2023
Recall number
Z-1181-2023
Initiated
December 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Covidien, LP
Quantity
40152 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterile Barrier Breach

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

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Code information

GTIN: 20884521062303, 20884521059570, 20884521060101, 20884521059006, 20884521059396, 20884521060682, 20884521059013, 10884521059290, 20884521059297, 20884521059280, 10884521061194, 20884521061191, 20884521062327, 20884521059204, 20884521060637, 20884521105192, 20884521062921, 10884521058620, 20884521058627, 20884521060170, 20884521059471, 10884521061293, 20884521061290, 20884521061641, 20884521059020, 10884521060432, 20884521060439, 20884521104300, 20884521063034, 20884521062655, 10884521062320, 10884521059900, 20884521059907, 20884521060361, 20884521059372, 20884521059990, 20884521060095, 20884521059464, 20884521062488, 10884521061507, 20884521061504. Model Number Lot # 8886277531 D1M0276Y 8886288041 D1L1698Y 8886301261 D1D3149FY 8886301561 D1E1922Y 8886301751 D2A0889Y 8886302671 D2C1802Y 8886303551 D1L0984Y 8886304741 D1G1844FY 8886304851 D1G0895FY 8886305061 D2C1969FY 8886305451 D1D3218FY 8886305689 D2D0199Y 8886305953 D1M1287FY 8886307051 D1D2540FY 8886308851 D2B2868Y 8886309051 D2B1332Y 8886309271 D2C2450Y 8886310943 D2C2451FY 8886311179 D1D2597Y 8886311961 D1M1166Y 8886315409 D2B2884Y 8886315931 D2B0542Y 8886316041 D1L1697Y D2B0543Y 8886316361 D1E0506Y 8886318541 D1J1639Y D1M2717Y D1M2851Y 8886318641 D1M2844Y D2A0933Y D2E0947Y D2E1925Y 8886321251 D2E3008Y 8886322641 D2A0451Y 8886328021 D1D0290Y 8886328031 D1L0721Y D1L2169Y D2B2861Y 8886330971 D2D2188Y 8886336931 D2B2738Y D2E0660Y D2F0767Y 8886339351 D1M0107Y D1M1299Y CD3123K D2B2213Y

Distribution pattern

US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Georgia Germany Ghana Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy JAPAN Jordan Kazakhstan Kenya Korea, Republic Of Kosovo Kuwait Latvia Lebanon Lithuania Macao Malaysia Malta Mauritius Mexico Moldova, Republic Of Morocco Myanmar Namibia Netherlands New Zealand North Macedonia Norway Pakistan Panama Paraguay Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam Zimbabwe

device · product 11 of 11

Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK

Z-1182-2023
Recall number
Z-1182-2023
Initiated
December 02, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Covidien, LP
Quantity
9606

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterile Barrier Breach

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

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Code information

GTIN: N/A Model Number Lot # US1638: A1K0289Y, A1K0291Y, US1638 A1K0283Y ; US1756: A2E0454Y

Distribution pattern

US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Georgia Germany Ghana Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy JAPAN Jordan Kazakhstan Kenya Korea, Republic Of Kosovo Kuwait Latvia Lebanon Lithuania Macao Malaysia Malta Mauritius Mexico Moldova, Republic Of Morocco Myanmar Namibia Netherlands New Zealand North Macedonia Norway Pakistan Panama Paraguay Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam Zimbabwe

Field note

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