Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 27, 2017
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
Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Terumo Cardiovascular Systems Corporation recalled Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (… - a moderate-severity action.
Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (… was recalled by Terumo Cardiovascular Systems Corporation in December 27, 2017. Reason: Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (…. Check the official notice for the remedy. Verify recall #Z-0257-2018 with the FDA Devices before acting.
The recall
Terumo Cardiovascular Systems Corporation issued this moderate-severity FDA Devices recall-Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (….
- Moderate
- severity level
- 214K units
- affected scope
- Class II
- classification
- December 27, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0257-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0257-2018) was formally reported on December 27, 2017, with the manufacturer initiating the action on June 27, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Terumo Cardiovascular Systems Corporation is listed as the recalling firm, operating out of Elkton, MD. Federal records list the affected scope as 214146 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve. Distribution data in the federal record shows the product reached: Worldwide distribution: US, Canada, Colombia, UK, Belgium, and Japan. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
214146 units
Related Recalls
6
0 from same agency
Product description
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
Reason for recall
Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0257-2018 |
| Date reported | December 27, 2017 |
| Date initiated | June 27, 2017 |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Firm location | Elkton, MD |
| Affected scope | 214146 units |
| Distribution | Worldwide distribution: US, Canada, Colombia, UK, Belgium, and Japan |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0257-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was 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. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 214146 units.
Why was this product recalled? ▼
Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 27, 2017. Severity: Moderate. Recall number: Z-0257-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: US, Canada, Colombia, UK, Belgium, and Japan.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0257-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 27, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.