Turbett Surgical Container, TS1500
Medical device recall Z-1111-2022. Published in FDA’s Enforcement Report on May 25, 2022.
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 May 25, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 3 states named in where it went
- 232 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?
Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Turbett Surgical Container, TS1500
232 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI (GTIN): 00859464007113 Lot # S/N 100036 2017051001 100036 2017051004 100036 2017051005 100036 2017061018 100036 2017061026 100036 2017051000 100036 2017051003 100036 2017061021 100036 2017061022 100036 2017061020 100036 2017061011…
Every code shown here, 1,992 characters
UDI-DI (GTIN): 00859464007113 Lot # S/N 100036 2017051001 100036 2017051004 100036 2017051005 100036 2017061018 100036 2017061026 100036 2017051000 100036 2017051003 100036 2017061021 100036 2017061022 100036 2017061020 100036 2017061011 100036 2017061012 100001 2016071009 100001 2016081005 ***Updated 7/11/22*** Lot # S/N 100036 2017051006 100036 2017051008 100181 2019081010 160522-1 2016071003 160522-1 2016071007 160522-1 2016071008 160522-1 2016071010 100004 2016091006 100004 2016091007 100065 2017121003 100065 2017121007 100125 2018010001 100125 2018010010 100099 2018011002 100099 2018011009 100099 2018011011 100099 2018031005 100099 2018031006 100099 2018031007 100083 2018031009 100083 2018031010 100083 2018031011 100083 2018031012 100083 2018031013 100099 2018081003 100099 2018081004 100099 2018081005 100099 2018081006 100099 2018081007 100099 2018081008 100099 2018081009 100099 2018081010 100099 2018091001 100099 2018091002 100099 2018091003 100099 2018091004 100099 2018091005 100099 2018091006 100099 2018091007 100099 2018091008 100125 2018111001 100125 2018111002 100125 2018111003 100125 2018111004 100125 2018111005 100125 2018111006 100125 2018111007 100125 2018111008 100125 2018111009 100125 2018111010 100125 2018111011 100125 2018111012 100125 2018111013 100125 2018111014 100130 2018121001 100130 2018121002 100125 2018121003 100130 2018121004 100130 2018121006 100130 2018121008 100130 2018121010 100130 2018121012 100130 2018121015 100130 2019011001 100130 2019011002 100130 2019011003 100130 2019011004 100130 2019011005 100130 2019011006 100130 2019011007 100130 2019011008 100130 2019011009 100130 2019011010 100130 2019021001 100130 2019021002 100130 2019021004 100130 2019021005 100130 2019021006 100130 2019021007 100130 2019021008 100130 2019021009 100150 2019031001 100150 2019031002 100150 2019031003 100150 2019031005 100150 2019031006 100150 2019031007 100150 2019031008 100150 2019031011 100150 2019031012 160522-1 2016071000 160522-1 2016071001…
FDA’s list runs to 4,269 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.
Domestic distribution to PA, CA, and NY only.
The states and territories these words name
- California
- New York
- Pennsylvania
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Apr 1, 2022.
- FDA classified it on May 18, 2022.
- FDA’s Enforcement Report published it on May 25, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- TURBETT SURGICAL, LLC, of Victor, NY.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
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 4,269 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.