Use caution Medical device recall · FDA · Published June 27, 2017
Terumo Overpressure Safety Valve Recall: No Flow Risk
Terumo recalls overpressure safety valves (LH130/LH130J) with no flow reported. Affected units have specific lot codes and distribution dates. Stop using if no flow occurs.
Use caution until it’s fixed
Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.
Contact the company
Recalling firmTerumo Cardiovascular Systems Corporation125 Blue Ball Rd · Elkton, MD 21921-5315
What happened, in plain English
Terumo is recalling overpressure safety valves (LH130 and LH130J) because they have reported no flow. This could lead to improper blood flow during medical procedures, which is dangerous for patients. Read more at govinfonow.com/recall/73558-terumo-overpressure-safety-valve-recall-no-flow-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73558-terumo-overpressure-safety-valve-recall-no-flow-risk · Updated September 21, 2026 · FDA enforcement record: FDA #Z-0256-2018
Cite this page
“Terumo Overpressure Safety Valve Recall: No Flow Risk.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73558-terumo-overpressure-safety-valve-recall-no-flow-risk. Based on FDA recall #Z-0256-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0256-2018%22&limit=1).
Why it’s dangerous
The overpressure safety valve may not allow blood flow when needed, potentially causing complications during medical procedures. This could lead to serious issues like blood clots or inadequate treatment.
Who’s affected
Patients using these valves during medical procedures are most at risk. Healthcare providers who use the valves in cardiac surgeries or other critical care settings are also affected.
How to tell if you have this one
Check the valve's lot code or serial number. Affected models are LH130 and LH130J with specific lot codes listed in the recall notice (e.g., TA19 through VD06) and distribution dates from April 2015 to January 2017.
- Brand
Terumo- Category
Medical device
All 2 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
Worldwide distribution: US, Canada, Colombia, UK, Belgium, and Japan
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0256-2018 | TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J; SAFETY ALERT Lot Codes: (a) RH14, RK11, RK20, RL02, RM06, RM20, RN10, RP08, TD16, TE13, TE27, TF14, TF21, TG04, TG11, TG17, TH06, TH16, TK10, TK24, TL08, TL21, TM28, TP14, UA11, UA18, UA25, UC08, UC22, UD14, UD21, UD28, UE05, UE18, UF09, UG06, UK01, UL12, UM10, UM31, UP05, VA02, VC06, VD06, VE10 (b) RH14, RH21, RK18, RL15, RM01, RM22, RN24, RP01, TA19, TF05, TF27, TG19, TH20, TK24, TL01, TM12, TN09, TP03, UA20, UC15, UD22, UE04, UE18, UF02, UG13, UH11, UK15, UL06, UM10, VA02, VA30, VC27, VE03, VF01 LH130 PRODUCT CORRECTION lot codes or serial number range: TA19 through VD06, distribution date range: 08Apr2015 through 20Jan2017 | 297,222 units |
| Z-0257-2018 | 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; 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 71156 TM12 71156 TM12 71156 TM12 71156 TN30 71156 TN30 71156 TN30 71156 TN30 71156 TN30 71156 TN30 71156 UA04 71156 UA04 71156 UA04 71156 UA04 71156 UA04 71156 UC29 71156 UC29 71156 UC29 71156 UC29 71156 UC29 71156 UC29 71156 UC29 71156 UD21 71156 UD21 71156 UD21 71156 UD21 71156 UD21 71156 UD21 71156 UD28 71156 UD28 71156 UD28 71156 UD28 71156 UD28 71156 UD28 71156 UE04 71156 UE04 71156 UE04 71156 UE04 71156 UE04 71156 UG13 71156 UG13 71156 UG13 71156 UG13 71156 UG13 71156 UG13 71156 UG13 71156 UG27 71156 UG27 71156 UG27 71156 UG27 71156 UG27 71156 UG27 71156 UC01 71156 UC01 71156 UC01 71156 UC01 71156 UK01 71156 UK01 71156 UK01 71156 UK01 71156 UK01 71156 UK01 71156 UM10 71156 UM10 71156 UM10 71156 UM10 71156 UM10 71156 UM10 71156 UM10 71156 UM10 71156 UM10 71156 UM10 71156 VA02 71156 VA02 71156 VA02 71156 VA02 71156 VA02 71156 VA02 71156 VA02 71156 UP12 71156 UP12 71156 UP12 71156 UP12 71156 VA09 71156 VA09 71156 VA09 71156 VA09 71156 VA09 71156 VD20 71156 VD20 71156 VD20 71156 VD20 71156 VD20 71156 VD20 71156 VD20 71156 VD20 71156 VD20 71156 VD20 71156 VD20 71156 VE17 71156 VE17 71156 VE17 71551-02 TK10 71551-02 TK10 71551-02 TK10 71551-02 TH27 71551-02 TH27 71551-02 TH27 71551-02 TH27 71551-02 TH27 71551-02 TK24 71551-02 TK24 71551-02 TK24 71551-02 TK24 71551-02 TK24 71551-02 TK24 71551-02 TK24 71551-02 TK24 71551-02 TK24 71551-02 TK24 71551-02 TK24 71551-02 TL28 71551-02 TL28 71551-02 TL28 71551-02 TL28 71551-02 TL28 71551-02 TL28 71551-02 TL28 71551-02 TL28 71551-02 TL28 71551-02 TL28 71551-02 VF08 71551-02 VF08 71551-02 VE03 71551-02 VE03 71551-02 VE03 71551-02 VE03 71551-02 VE03 71551-02 VE03 71551-02 VE03 71551-02 VE03 71551-02 VE03 71551-02 VE03 71551-02 TP14 71551-02 TP14 71551-02 TP14 71551-02 TP14 71551-02 TP14 71551-02 TP14 71551-02 TP14 71551-02 UA04 71551-02 UA04 71551-02 UA04 71551-02 UA04 71551-02 UA04 71551-02 UA04 71551-02 UA04 71551-02 UC08 71551-02 UC08 71551-02 UC08 71551-02 UC08 71551-02 UC08 71551-02 UC08 71551-02 UC08 71551-02 UC08 71551-02 UC08 71551-02 UC08 71551-02 UD07 71551-02 UD07 71551-02 UD07 71551-02 UD07 71551-02 UD07 71551-02 UD07 71551-02 UD07 71551-02 UE04 71551-02 UE04 71551-02 UE04 71551-02 UE04 71551-02 UE04 71551-02 UE04 71551-02 UE25 71551-02 UE25 71551-02 UE25 71551-02 UE25 71551-02 UE25 71551-02 UE25 71551-02 UE25 71551-02 UF23 71551-02 UF23 71551-02 UF23 71551-02 UF23 71551-02 UF23 71551-02 UF23 71551-02 UF23 71551-02 UF23 71551-02 UF23 71551-02 UG27 71551-02 UG27 71551-02 UG27 71551-02 UG27 71551-02 UG27 71551-02 UG27 71551-02 UG27 71551-02 UG27 71551-02 UG27 71551-02 UG27 71551-02 UH25 71551-02 UH25 71551-02 UH25 71551-02 UH25 71551-02 UH25 71551-02 UL19 71551-02 UL19 71551-02 UL19 71551-02 UL19 71551-02 UL19 71551-02 UL19 71551-02 UL19 71551-02 UM24 71551-02 UM24 71551-02 UM24 71551-02 UM24 71551-02 UM24 71551-02 UM24 71551-02 UM24 71551-02 UM24 71551-02 UM24 71551-02 UM24 71551-02 UM24 71551-02 UM24 71551-02 UN28 71551-02 UN28 71551-02 UN28 71551-02 UN28 71551-02 UN28 71551-02 UN28 71551-02 UN28 71551-02 UN28 71551-02 UN28 71551-02 VA02 71551-02 VA02 71551-02 VA02 71551-02 VA02 71551-02 VA02 71551-02 VA02 71551-02 VA02 71551-02 UK15 71551-02 UK15 71551-02 UK15 71551-02 UK15 71551-02 UK15 71551-02 UK15 71551-02 VA16 71551-02 VA16 71551-02 VA16 71551-02 VA16 71551-02 VA16 71551-02 VC20 71551-02 VC20 71551-02 VC20 71551-02 VC20 71551-02 VC20 71551-02 VC20 71551-02 VC20 71551-02 VC20 71551-02 VC20 71551-02 VC20 71551-02 VC20 71413 TH13 71413 TH13 71413 TH13 71413 TH13 71413 TH13 71413 TH13 71413 TK10 71413 TK10 71413 TK10 71413 TK10 71413 TK10 71413 TL28 71413 TL28 71413 TL28 71413 TL28 71413 TL28 71413 TL28 71413 TN09 71413 TN09 71413 TN09 71413 TN09 71413 TN09 71413 TN09 71413 UA04 71413 UA04 71413 UA04 71413 UA04 71413 UA04 71413 UC22 71413 UC22 71413 UC22 71413 UC22 71413 UC22 71413 UC22 71413 UC22 71413 UC22 71413 UD14 71413 UD14 71413 UD14 71413 UD14 71413 UD14 71413 UD14 71413 UG27 71413 UG27 71413 UG27 71413 UG27 71413 UK08 71413 UK08 71413 UK08 71413 UK08 71413 UK22 71413 UK22 71413 UK22 71413 UE11 71413 UE11 71413 UE11 71413 UE11 71413 UE11 71413 UF23 71413 UF23 71413 UF23 71413 UF23 71413 UF23 71413 UM03 71413 UM03 71413 UM03 71413 UM03 71413 UN28 71413 UN28 71413 UN28 71413 UN28 71413 VA02 71413 VA02 71413 VA02 71413 VA02 71413 VA02 71413 VA02 71413 VA23 71413 VA23 71413 VA23 71413 VA23 71413 VA23 71413 VA23 71413 VD13 71413 VD13 71413 VD13 71413 VD13 71413 VD13 71413 VD13 71413 VD13 71413 VE17 71413 VE17 71413 VE17 71413 VE17 71413 VE17 71692 TP07 74102 TH06 74102 TH06 74102 TH06 74102 TK31 74102 TK31 74102 TK31 74102 TK31 74102 TL28 74102 TL28 74102 TL28 74102 TP14 74102 TP14 74102 TP14 74102 TP14 74102 TM19 74102 TM19 74102 TM19 74102 TM19 74102 UA18 74102 UA18 74102 UA18 74102 UA18 74102 UD14 | 214146 units |
What to do — step by step
Check Valve Lot Code
Look for the lot code on the valve, which should match the listed codes (e.g., TA19 through VD06) for affected units.
Stop Using if No Flow
If the valve shows no flow during medical procedures, stop using it immediately and contact your healthcare provider.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- 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-0256-2018 (June 27, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0256-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 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.