Custom surgical kits containing TERUMO(R) Overpressure Safety Valve
Medical device recall Z-0257-2018. Published in FDA’s Enforcement Report on Dec 27, 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 Dec 27, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 214146 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?
Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130 74369 71156 71551-02 71413 71692 74102 75490 74432-01 75477 75478 75104-02 75104-03 75477-01 75037 75973 75308-01 75688 70571-06 75114-01 72755 73306 71180-01 73307 75163 75164 75787 75163-01 73055-02 75450 75451 75452 75453 75453-01 75999 75451-01 72481-01 75197 73968 75416 73648 71519-02 71801-01 72846 74163-02 74178-03 74986 75607 74162-01 74163-03 73454-01 71296-01 74924 73344-04 73500-04 74924-01 73143-02 76393 74248-01 73820-01 75261 75594 74022-01 66001-01 66004-01 74916 72736-02 B72736-02 70815 70815-01 70815-02 74356-02 73208-03 73001-02 73957-01 74460-01 70089-06 75168 75171 75240 74382-01 66467 70089-07 74965-03 75168-01 75240-01 66467-01 70089-08 73177 76006 73177-01 76038 75252-01 76316 75805-02 73346 76414 75790 75678 62007-01 66229 75075 62007-02 65382 75788 75788-01 70533-10 75936 75936-01 63123 72241 70148-02 70730 70772 74732 75090 75090-01 75090-02 75089-01 73468 74430 74921-02 75881 64523-02 64619-02 64522-03 64521-02 65560-03 64912-04 65560-04 71064 65570 71062-01 71061-02 71060-01 71962-04 71965-04 75948 71962-05 74401-01 74400-01 74399-02 75944 759
214146 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
SAFETY ALERT Lot Codes: US Distribution: Catalog Number Lot Code 74369 TH20 74369 TH20 74369 TH27 74369 TH27 74369 TK10 74369 TL08 74369 TL08 74369 TL21 74369 TL21 74369 TM05 74369 TM05 74369 TM19 74369 TM19 74369 TM26 74369 TM26 74369…
Every code shown here, 2,000 characters
SAFETY ALERT Lot Codes: US Distribution: Catalog Number Lot Code 74369 TH20 74369 TH20 74369 TH27 74369 TH27 74369 TK10 74369 TL08 74369 TL08 74369 TL21 74369 TL21 74369 TM05 74369 TM05 74369 TM19 74369 TM19 74369 TM26 74369 TM26 74369 TM26 74369 TN16 74369 TN16 74369 TP07 74369 TP07 74369 TP14 74369 TP14 74369 TP14 74369 UA25 74369 UA25 74369 UA25 74369 UA25 74369 UC01 74369 UC01 74369 UC01 74369 UC01 74369 UC22 74369 UC22 74369 UC22 74369 UC22 74369 UC29 74369 UC29 74369 UC29 74369 UC29 74369 UD28 74369 UD28 74369 UD28 74369 UE04 74369 UE04 74369 UE04 74369 UE04 74369 UF09 74369 UF09 74369 UF09 74369 UF09 74369 UF09 74369 UF09 74369 UG06 74369 UG06 74369 UG06 74369 UG06 74369 UG06 74369 UG20 74369 UG20 74369 UG20 74369 UG20 74369 UG20 74369 UH18 74369 UH18 74369 UH18 74369 UK01 74369 UK01 74369 UK01 74369 UK01 74369 UK01 74369 UK22 74369 UK22 74369 UK22 74369 UK22 74369 UK22 74369 UK22 74369 UL12 74369 UL12 74369 UL12 74369 UL12 74369 UL26 74369 UL26 74369 UL26 74369 UL26 74369 UL26 74369 UM03 74369 UM03 74369 UM03 74369 UM03 74369 UM24 74369 UM24 74369 UM24 74369 UM24 74369 UM24 74369 UM31 74369 UM31 74369 UM31 74369 UM31 74369 UM31 74369 UM31 74369 UN28 74369 UN28 74369 UN28 74369 UN28 74369 UP05 74369 UP05 74369 UP05 74369 UP05 74369 UP05 74369 UP05 74369 VA02 74369 VA02 74369 VA02 74369 VA02 74369 VA02 74369 VA09 74369 VA09 74369 VA09 74369 VA09 74369 VA09 74369 VA23 74369 VA23 74369 VA23 74369 VA23 74369 VA23 74369 VA23 74369 VC06 74369 VC06 74369 VC06 74369 VC06 74369 VC06 74369 VD06 74369 VD06 74369 VD06 74369 VD06 74369 VD06T 74369 VD06T 74369 VD06T 74369 VD06T 74369 VD06T 74369 VE03 74369 VE03 74369 VE03 74369 VE03 74369 VE03 74369 VE03 74369 VE10 74369 VE10 74369 VE10 74369 VE10 74369 VE10 74369 VE24 74369 VE24 74369 VE24 74369 VE24 74369 VE24 74369 VF22T 74369 VF22T 74369 VF22T 74369 VF22T 74369 VF22T 71156 TK10 71156 TK10 71156 TK10 71156 TK10 71156 TK31 71156 TK31 71156 TK31 71156 TK31 71156 TK31 71156 TK31 71156 TK31 71156 TM12 71156 TM12 71156 TM12…
FDA’s list runs to 1,774,940 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, Canada, Colombia, UK, Belgium, and Japan
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Jun 27, 2017.
- FDA classified it on Dec 18, 2017.
- FDA’s Enforcement Report published it on Dec 27, 2017.
- FDA terminated it on Jul 16, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Terumo Cardiovascular Systems Corporation, of Elkton, MD.
- 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 1,774,940 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.