Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 13, 2019
Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI syste
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Western / Scott Fetzer Company recalled Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti … - a moderate-severity action.
Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti … was recalled by Western / Scott Fetzer Company in November 13, 2019. Reason: Limited access to flow settings as a result of the control knob having been rotated beyond its functional ra…. Check the official notice for the remedy. Verify recall #Z-0342-2020 with the FDA Devices before acting.
The recall
Western / Scott Fetzer Company issued this moderate-severity FDA Devices recall-Limited access to flow settings as a result of the control knob having been rotated beyond its functional ra….
- Moderate
- severity level
- 26K units
- affected scope
- Class II
- classification
- November 13, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0342-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0342-2020) was formally reported on November 13, 2019, with the manufacturer initiating the action on August 15, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Western / Scott Fetzer Company is listed as the recalling firm, operating out of Westlake, OH. Federal records list the affected scope as 25,840 units.
The documented reason for this recall is: Limited access to flow settings as a result of the control knob having been rotated beyond its functional range Distribution data in the federal record shows the product reached: Worldwide distribution US Nationwide distributions in the states of OH, NY, PA, TX, MA, MI, KS, IL, MD, MN, WA, TN, UT, CA, NJ, LA, CT, OR, ND, RI, WI, PR, FL, ON, NV, NB, OK, IN, AZ, MS, GA, IA and countries of Costa…. 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
25,840 units
Related Recalls
6
3 from same agency
Product description
Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.
Reason for recall
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0342-2020 |
| Date reported | November 13, 2019 |
| Date initiated | August 15, 2019 |
| Recalling firm | Western / Scott Fetzer Company |
| Firm location | Westlake, OH |
| Affected scope | 25,840 units |
| Distribution | Worldwide distribution US Nationwide distributions in the states of OH, NY, PA, TX, MA, MI, KS, IL, MD, MN, WA, TN, UT, CA, NJ, LA, CT, OR, ND, RI, WI, PR, FL, ON, NV, NB, OK, IN, AZ, MS, GA, IA and countries of Costa Rica, Mexico. |
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-0342-2020) 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? ▼
Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.. Recalled by Western / Scott Fetzer Company. Units affected: 25,840 units.
Why was this product recalled? ▼
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2019. Severity: Moderate. Recall number: Z-0342-2020.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution US Nationwide distributions in the states of OH, NY, PA, TX, MA, MI, KS, IL, MD, MN, WA, TN, UT, CA, NJ, LA, CT, OR, ND, RI, WI, PR, FL, ON, NV, NB, OK, IN, AZ, MS, GA, IA and countries of Costa Rica, Mexico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0342-2020) 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 November 13, 2019. 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.