Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number:…
Medical device recall Z-2541-2017. Published in FDA’s Enforcement Report on Jun 21, 2017.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 21, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 478,465 (total for all products) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
478,465 (total for all products), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,998 characters
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…
FDA’s list runs to 3,910 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
The states and territories these words name
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 3, 2017.
- FDA classified it on Jun 14, 2017.
- FDA’s Enforcement Report published it on Jun 21, 2017.
- FDA terminated it on Jul 18, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic, of North Haven, CT.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,910 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.