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Lower risk Medical device recall · FDA · Published December 18, 2019

Covidien Polysorb Suture Recall: Packaging Humidity/Sterility Risk

Covidien recalls specific Polysorb suture lots due to potential packaging issues that could affect humidity or sterility. Affected items may not be safe for surgery.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1293-2020Medical deviceCovidien ›
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Contact the company

Recalling firmCovidien LLC60 Middletown Ave · North Haven, CT 06473-3908
✎ GovInfoNow plain-language explainer

Covidien is recalling certain Polys: 6/0 18" UNDYED P-10 sutures with item code SL1625G. The recall is because specific production lots might have packaging that doesn't keep humidity or sterility properly, which could make the suture unsafe for surgery. Read more at govinfonow.com/recall/66258-covidien-polysorb-suture-recall-packaging-humidity-sterility-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/66258-covidien-polysorb-suture-recall-packaging-humidity-sterility-risk · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1293-2020

Cite this page

“Covidien Polysorb Suture Recall: Packaging Humidity/Sterility Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/66258-covidien-polysorb-suture-recall-packaging-humidity-sterility-risk. Based on FDA recall #Z-1293-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1293-2020%22&limit=1).

The FDA announced on 2019-12-18 that Covidien LLC voluntarily recalled Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10 due to potential packaging integrity issues affecting sterility. The recall affects 139,938 units distributed nationwide in the US.

How to tell if you have it

  • Brand: Covidien
  • Product: Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10
  • Item Code: SL1625G
  • Lot Code: -D7H1214X
  • Expiration Date: 2022-08-31

The hazard

According to the FDA, there is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.

Context

GovInfoNow's records show Covidien LLC has 52 other recalls on record since 2017-08-07. Other recent recalls include the Covidien EndoFLIP System recall (2026-05-13), the Covidien Mon-a-Therm Stethoscope Recall (2026-04-23), and the Covidien Shiley Disposable Decannulation Plug Recall (2026-04-23). Similar product recalls include the Covidien Dermalon 4-0 Blue 75cm Sutures Recall (2026-06-24), the Covidien EndoStitch Polysorb Loading Unit Recall (2026-04-15), and the Covidien V-Loc 180 Absorbable Wound Closure Device Recall (2026-06-24).

How to tell if you have this one

Check for the item code SL1625G on the packaging. The specific lot number D7H1214X with expiration date August 31, 2022 is affected.

  • Brand
    Covidien
  • Category
    Medical device
FDA recall event · 27 products

All 27 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US Nationwide distribution.
Recall numberProduct, codes & lots
Z-1274-2020Polysorb 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.; Lot - D7H0876X Expiration Date - 2022-08-31
Z-1275-2020Polysorb 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.; Lot - A9J0018Y Expiration Date - 2024-08-31
Z-1276-2020Polysorb 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.; Lot - A9J0075Y Expiration Date - 2024-08-31
Z-1277-2020Polysorb 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.; Lot - A9H1170Y Expiration Date - 2024-07-31
Z-1278-2020Polysorb 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.; Lot - A9H1065Y Expiration Date - 2024-07-31
Z-1279-2020Polysorb 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.; Lot - A9J0006Y Expiration Date - 2024-08-31
Z-1280-2020Polysorb 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.; Lot - D7H1048X Expiration Date - 2022-08-31
Z-1281-2020Polysorb 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.; 1) Lot - A9H1186Y Expiration Date - 2024-07-31; 2) Lot A9J0015Y Expiration Date - 2024-08-31
Z-1282-2020Polysorb 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.; 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
Z-1283-2020Polysorb 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.; 1) Lot - A9H1189Y Expiration Date - 2024-07-31; 2) Lot - A9J0345Y Expiration Date - 2024-08-31
Z-1284-2020Polysorb 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.; 1) Lot - A9J0014Y Expiration Date - 2024-08-31; 2) Lot - A9J0193Y Expiration Date - 2024-08-31
Z-1285-2020Polysorb 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.; Lot - A9K0004Y Expiration Date - 2024-09-30
Z-1286-2020Polysorb 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.; Lot - A9J0421Y Expiration Date - 2024-08-31
Z-1287-2020Polysorb 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.; Lot - A9J0053Y Expiration Date - 2024-08-31
Z-1288-2020Polysorb 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.; Lot - D7H0794X Expiration Date - 2022-08-31
Z-1289-2020Polysorb 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.; Lot - A9J0384Y Expiration Date - 2024-08-31
Z-1290-2020Polysorb 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.; Lot - D7G0387X Expiration Date - 2022-07-31
Z-1291-2020Polysorb 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.; Lot -D7H1126X Expiration Date - 2022-08-31
Z-1292-2020Polysorb 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.; Lot -D7H1092X Expiration Date - 2022-08-31
Z-1293-2020Polysorb 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.; Lot -D7H1214X Expiration Date - 2022-08-31
Z-1294-2020Polysorb 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.; Lot -A9H0847FY Expiration Date - 2024-07-31
Z-1295-2020Polysorb 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.; 1) Lot -D7G2298X Expiration Date - 2022-07-31; 2) Lot - D7H0091X Expiration Date - 2022-08-31
Z-1296-2020Polysorb 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.; Lot - D7H0946X Expiration Date - 2022-08-31
Z-1297-2020Polysorb 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.; 1) Lot - D7G2301X Expiration Date - 2022-07-31; 2) Lot - D7H0092X Expiration Date - 2022-08-31
Z-1298-2020Polysorb 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.; Lot - D7H0796X Expiration Date - 2022-08-31
Z-1299-2020Polysorb 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.; Lot - D7H0866X Expiration Date - 2022-08-31
Z-1300-2020Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201; Lot - D7H0404X Expiration Date - 2022-08-31
Based on the official FDA remedy

What to do — step by step

  1. Check Packaging Details

    Look for item code SL1625G and lot number D7H1214X on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.7 years after the firm started it.

1. Firm started the recall: Dec 18, 201912. FDA classified it Class II: Feb 19, 202023. Published in FDA’s Enforcement Report: Feb 26, 202034. FDA terminated the recall: Aug 16, 2022420192022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1293-2020 (December 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1293-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA