Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 13, 2020
Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile
Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFit Sterile Single Use Thigh Cuffs, Single Port, Single Bladder models may have been…
Delfi Medical Innovations, Inc. recalled Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single por… - a moderate-severity action.
Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single por… was recalled by Delfi Medical Innovations, Inc. in May 13, 2020. Reason: Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFit Sterile Si…. Check the official notice for the remedy. Verify recall #Z-1901-2020 with the FDA Devices before acting.
The recall
Delfi Medical Innovations, Inc. issued this moderate-severity FDA Devices recall-Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFit Sterile Si….
- Moderate
- severity level
- 59 units
- affected scope
- Class II
- classification
- May 13, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1901-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1901-2020) was formally reported on May 13, 2020, with the manufacturer initiating the action on April 3, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Delfi Medical Innovations, Inc. is listed as the recalling firm, operating out of Vancouver, N/A. Federal records list the affected scope as 59 units.
The documented reason for this recall is: Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFit Sterile Single Use Thigh Cuffs, Single Port, Single Bladder models may have been manufactured with an inadequate perimet… Distribution data in the federal record shows the product reached: US: Ohio OUS: Austrailia. 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, 3 from FDA Devices - 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 - 40,322 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
59 units
Related Recalls
6
3 from same agency
Product description
Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile
Reason for recall
Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFit Sterile Single Use Thigh Cuffs, Single Port, Single Bladder models may have been manufactured with an inadequate perimeter weld on the cuff. Once applied to a patients thigh and inflated to a pressure to occlude blood flow in the thigh distal to the cuff, after a period of time the cuff may leak to the extent that the tourniquet instrument supplying air pressure to the cuff may not be able to adequately control and regulate pressure in the cuff. This may result in some blood flow in the thigh distal to the cuff.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1901-2020 |
| Date reported | May 13, 2020 |
| Date initiated | April 3, 2019 |
| Recalling firm | Delfi Medical Innovations, Inc. |
| Firm location | Vancouver, N/A |
| Affected scope | 59 units |
| Distribution | US: Ohio OUS: Austrailia |
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-1901-2020) 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? ▼
Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile. Recalled by Delfi Medical Innovations, Inc.. Units affected: 59 units.
Why was this product recalled? ▼
Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFit Sterile Single Use Thigh Cuffs, Single Port, Single Bladder models may have been manufactured with an inadequate perimeter weld on the cuff. Once applied to a patients thigh and inflated to a pressure to occlude blood flow in the thigh distal to the cuff, after a period of time the cuff may leak to the extent that the tourniquet instrument supplying air pressure to the cuff may not be able to adequately control and regulate pressure in the cuff. This may result in some blood flow in the thigh distal to the cuff.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 13, 2020. Severity: Moderate. Recall number: Z-1901-2020.
Where was the recalled product distributed? ▼
Distribution: US: Ohio OUS: Austrailia.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1901-2020) 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 May 13, 2020. 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.