Surgipro II Monofilament Polypropylene Sutures Product Description
Medical device recall Z-1180-2023. Published in FDA’s Enforcement Report on Mar 8, 2023.
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 Mar 8, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 322152 units 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?
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
322152 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN: GTIN 20884521039534 20884521038902 20884521039596 20884521038810 10884521038813 20884521039565 10884521039568 20884521039466 10884521039469 10884521640061 20884521038940 10884521038943 20884521038841 20884521038896 10884521039599…
Every code shown here, 1,996 characters
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…
FDA’s list runs to 3,320 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.
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
These words name no state.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Dec 2, 2022.
- FDA classified it on Feb 25, 2023.
- FDA’s Enforcement Report published it on Mar 8, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Covidien, LP, 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 3,320 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
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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.