Medtronic: Medical Device Recall in 2017 - (Recall #: Z-2541-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VIO PRECUT 122J; Item Number: L15; POLSORB 1 30 VIO PRECUT 224E; Item Number: L405; POLSORB 4/0 60" REEL VIO 217T, Item Number: LL111; POLYSORB 0 18 UNDYED PRECUT, Item Number: L24; POLYSORB 0 18" UNDYED GS-21 DT, Item Number: CL14MG; POLYSORB 0 18" VIOLET PRECUT, Item Number: L27; POLYSORB 0 60 U/D REEL 203G, Item Number: LL104; POLYSORB 1 18" UNDYED PRECUT, Item Number: L25; POLYSORB 1 18" VIOLET GS-21 DT, Item Number: CL11MG; POLYSORB 1 30" VIOLET GS-21 DT, Item Number: CL6M; POLYSORB 1 30" VIOLET GS-22 DT, Item Number: CL885M; POLYSORB 1 30" VIOLET GS-25 DT, Item Number: CL64M; POLYSORB 2 VL 5 X 30" BGST-29 DT, Item Number: CLT633M; POLYSORB 2/0 18" UNDYED GS-10 DT, Item Number: CL52MG; POLYSORB 2/0 18" UNDYED GS-21 DT, Item Number: CL13MG; POLYSORB 2/0 18" VIOLET V-20 DT, Item Number: GL62MG; POLYSORB 2/0 30" VIOLET V-20 DT, Item Number: GL66M; POLYSORB 2-0 30" VIOLET V-30 DT, Item Number: GL223M; POLYSORB 3/0 18" UNDYED V-20 DT, Item Number: GL69MG; POLYSORB 3/0 18" VIOLET CV-25 DT, Item Number: GL33MG and GLJ50M; POLYSORB 3/0 18" VIOLET V-20 DT, Item Number: GL63MG; POLYSORB 3/0 30" VIOLET V-20 DT, Item Number: GL67M; POLYSORB 3/0 60 U/D REEL 104R, Item Number: LL102; POLYSORB 3-0 30" VIOLET CV-25 DT, Item Number: GL182M; POLYSORB 4/0 18" VIOLET CV-25 DT, Item Number: GL34MG; POLYSORB 4/0 30" VIOLET V-20 DT, Item Number: GL68M; POLYSORB* 0 18" VIOLET GS-21 DT, Item Number: CL10MG; POLYSORB* 0 24" VIOLET PRECUT, Item Number: L34; POLYSORB* 0 30" VIOLET GS-21 REG ATTCH, Item Number: 3CL812; POLYSORB* 0 30" VIOLET GS-22 DT, Item Number: CL886M; POLYSORB* 0 30" VIOLET PRECUT, Item Number: L40; POLYSORB* 0 5 X 30" UNDYED GS-21 DT, Item Number: CL2M; POLYSORB* 0 VIOLET 5X30" HGS-20 D-TACH, Item Number: CL997MG; POLYSORB* 0 VIOLET 5X30" HGS-21 D-TACH, Item Number: CL71M; POLYSORB* 0 VIOLET 60 REEL, Item Number: LL114; POLYSORB* 0 VIOLET 98" REEL, Item Number: LL224; POLYSORB* 1 18" VIOLET PRE-CUT, Item Number: L35; POLYSORB* 1 30" VIOLET PRECUT, Item Number: L41; POLYSORB* 1 5 X 30" VIOLET HOS-12 DT, Item Number: CL97MG; POLYSORB* 1 VIOLET 30" GS-26, Item Number: CL60M; POLYSORB* 1 VIOLET 98" REEL, Item Number: LL225; POLYSORB* 2 30" VIOLET GS-25 DT, Item Number: CL665M; POLYSORB* 2 UNDYED 12X18" PRECUT, Item Number: L26; POLYSORB* 2 VIOLET 12X18" PRECUT, Item Number: L28; POLYSORB* 2 VIOLET 2X36" BGS-29 (2X90CM), Item Number: 2CL852; POLYSORB* 2 VIOLET 30" GS-26, Item Number: CL659M; POLYSORB* 2 VIOLET 5X24" GS-24 D-TACH*, Item Number: CL622M; POLYSORB* 2 VIOLET 6X30" PRE-CUT, Item Number: L42; POLYSORB* 2 VIOLET 98" REEL, Item Number: LL226; POLYSORB* 2-0 VIOLET 60 REEL, Item Number: LL113; POLYSORB* 2-0 VIOLET 98" REEL, Item Number: LL223; POLYSORB* 3-0 VIOLET 60 REEL, Item Number: LL112; POLYSORB* 3-0 VIOLET 98" REEL, Item Number: LL222; POLYSORB* 4/0 98" VIOLET REEL 110T, Item Number: LL221

Product Classification:

Class II

Date Initiated: May 3, 2017

Date Posted: June 21, 2017

Recall Number: Z-2541-2017

Event ID: 77144

Reason for Recall:

Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

Status: Terminated

Product Quantity: 478,465 (total for all products)

Code Information:

POLSORB 0 18 U/D PRECUT 126R D4K0211X D4L1163X D5A0876X POLSORB 0 18 VIO PRECUT 226T D4L1165X D5A0247X D5A0248X D5A0546X POLSORB 0 30 VIO PRECUT 227C D4L1545X D5A0757X POLSORB 1 18 VIO PRECUT 122J D4L1161X D5A0096X POLSORB 1 30 VIO PRECUT 224E D5A0875X POLSORB 4/0 60"REEL VIO 217T D4L1509X POLYSORB 0 18 UNDYED PRECUT D4L1164X POLYSORB 0 18" UNDYED GS-21 DT D4L1756X D4L1758X D5A1745X POLYSORB 0 18" VIOLET PRECUT D5A0249X D5A0755X D5A1219X D5A1220X D5A1315X POLYSORB 0 60 U/D REEL 203G D4K1537X D5A1294X POLYSORB 1 18" UNDYED PRECUT D5A0551X POLYSORB 1 18" VIOLET GS-21 DT D4J0442X D4K2262X D4M0073X D5B0260X D5B0263X POLYSORB 1 30" VIOLET GS-21 DT D4L1431X POLYSORB 1 30" VIOLET GS-22 DT D4J0841X D4K0619X D4L0147X D4L0427X D4M0370X POLYSORB 1 30" VIOLET GS-25 DT D4J1987X POLYSORB 2 VL 5 X 30" BGST-29 DT D4K2021X POLYSORB 2/0 18" UNDYED GS-10 DT D4K2361X D4M0071X D5A1862X POLYSORB 2/0 18" UNDYED GS-21 DT D4L1968X D5A0070X D5A0071X D5A0072X D5A1034X D5A1035X D5B0193X POLYSORB 2/0 18" VIOLET V-20 DT D4L1180GX D5A0308GX D5A0528GX D5A1042GX D5B0427GX POLYSORB 2/0 30" VIOLET V-20 DT D4K1263GX POLYSORB 2-0 30" VIOLET V-30 DT D4L1371X POLYSORB 3/0 18" UNDYED V-20 DT D5A0171GX D5A0409GX D5A0962GX D5A1748GX D5A1805GX D5A1869GX D5B0242GX D5B0267GX D5B0539GX D5B0540GX POLYSORB 3/0 18" VIOLET CV-25 DT D4L0058X D4L0108X D4L0637X D4L0638X D4L0639X D4L2006X D4L2010X D4L2201X D4M0267X D4M0362X D5A0170X D5A0172X D5A0307X D5A0479X D5A0529X D5A0963X D5A1041X D5A1401X D5A1422X D5B0149X D5B0266X D5B0844X POLYSORB 3/0 18" VIOLET V-20 DT D4L1177GX D4L1179GX D4L1962GX D4L2077GX D4L2202GX D5A0306GX D5A0480GX D5A1039GX POLYSORB 3/0 30" VIOLET V-20 DT D5A0513GX D5A0515GX POLYSORB 3/0 60 U/D REEL 104R D5A1291X POLYSORB 3-0 30" VIOLET CV-25 DT D4K2438X POLYSORB 4/0 18" VIOLET CV-25 DT D5A0410X D5A1037X D5A1397X D5A1398X D5A1399X D5A1400X D5A1746X D5A1747X D5A1870X D5B0148X D5B0150X D5B0243X D5B0536X POLYSORB 4/0 30" VIOLET V-20 DT D4L0759GX POLYSORB* 0 18" VIOLET GS-21 DT D5A0169X D5A0303X D5A0304X D5A0305X D5A0406X D5A0478X D5A0524X D5A0525X D5A0526X D5A0889X D5A0890X D5A0961X D5A1031X D5A1032X D5A1033X D5A1392X D5A1393X D5A1394X D5A1395X D5A1396X D5A1743X D5A1861X D5B0014X D5B0261X D5B0264X D5B0423X D5B0424X POLYSORB* 0 24" VIOLET PRECUT D4K2023X D4L1547X POLYSORB* 0 30" VIOLET GS-21 REG ATTCH D5A1024X POLYSORB* 0 30" VIOLET GS-22 DT D4K1616X POLYSORB* 0 30" VIOLET PRECUT D4M1190X D5A0228X D5A0549X POLYSORB* 0 5 X 30" UNDYED GS-21 DT D4K1415X D5A1026X D5A1028X POLYSORB* 0 VIOLET 5X30" HGS-20 D-TACH D4L1563X D4M1020X POLYSORB* 0 VIOLET 5X30" HGS-21 D-TACH D4M0368X POLYSORB* 0 VIOLET 60 REEL D4L1866X D5A0869X POLYSORB* 0 VIOLET 98" REEL D4L0689X D4L1166X D4L1677X D4L1867X D4L2107X D4M1187X D5A0723X D5A0724X D5A1298X POLYSORB* 1 18" VIOLET PRE-CUT D4K1272X D4L1740X D4M1189X D4M1224X D5A0756X POLYSORB* 1 30" VIOLET PRECUT D4K2024X D4L1162X D5A0548X POLYSORB* 1 5 X 30" VIOLET HOS-12 DT D4L1159X POLYSORB* 1 VIOLET 30" GS-26 D4L1131X POLYSORB* 1 VIOLET 98" REEL D4J0947X D4L0704X D4L2029X D4L2109X D5A0823X D5A0951X POLYSORB* 2 30" VIOLET GS-25 DT D4K1044X POLYSORB* 2 UNDYED 12X18" PRECUT D4J0736X D4K0212X D5A0402X POLYSORB* 2 VIOLET 12X18" PRECUT D4K2022X D4L1546X POLYSORB* 2 VIOLET 2X36" BGS-29 (2X90CM) D4L0467X POLYSORB* 2 VIOLET 30" GS-26 D4M0542X POLYSORB* 2 VIOLET 5X24" GS-24 D-TACH* ( D4L0692X POLYSORB* 2 VIOLET 6X30" PRE-CUT D5A0098X POLYSORB* 2 VIOLET 98" REEL D4L0640X D4L0641X D4L0642X POLYSORB* 2-0 VIOLET 60 REEL D4L0065X D4L0515X D4L1429X D4L2118X D4M0410X D5A0104X D5A0109X POLYSORB* 2-0 VIOLET 98" REEL D4K1392X D4K1612X D4K2139X D4L0279X D4L0822X D4L1005X D4L1399X D4L2111X D4M1186X D5A0102X D5A0105X D5A0106X D5A0107X D5A0112X D5A0113X D5A1233X D5A1290X D5A1339X D5B0302X POLYSORB* 3-0 VIOLET 60 REEL D4L1170X D4L2106X D5A0110X D5A0771X D5A0811X POLYSORB* 3-0 VIOLET 98" REEL D4K2315X D5A1231X D5A1803X POLYSORB* 4/0 98" VIOLET REEL 110T D4L1169X D4M0237X D5A1288X D5A1297X

Distribution Pattern:

Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.

Voluntary or Mandated:

Voluntary: Firm initiated