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LowClass IIITerminated

FDA Devices recall · Reported November 23, 2016

RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U

Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen¿ Generator, because the instructions for use…

Recall #
Z-0584-2017
Affected scope
2,675
Initiated
October 11, 2016
Compiled from official public sources by the editorial team.
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Stryker Instruments Div. of Stryker Corporation recalled RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U - a low-severity action.

RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U was recalled by Stryker Instruments Div. of Stryker Corporation in November 23, 2016. Reason: Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Rad…. Check the official notice for the remedy. Verify recall #Z-0584-2017 with the FDA Devices before acting.

The recall

Stryker Instruments Div. of Stryker Corporation issued this low-severity FDA Devices recall-Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Rad….

Low
severity level
3K units
affected scope
Class III
classification
November 23, 2016
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0584-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-0584-2017) was formally reported on November 23, 2016, with the manufacturer initiating the action on October 11, 2016. It is classified under Low severity (Class III), with a current status of Terminated. Stryker Instruments Div. of Stryker Corporation is listed as the recalling firm, operating out of Portage, MI. Federal records list the affected scope as 2,675.

The documented reason for this recall is: Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen¿ Generator, because the instructions for use incorrectly contained instructions supp… Distribution data in the federal record shows the product reached: Domestic:AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY Foreign:Fr…. 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

-1,00001,0002,0003,0004,000 20052008201120142017202020232026 1,248
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Low

Affected scope

2,675

Related Recalls

6

3 from same agency

Product description

RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U

Reason for recall

Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen¿ Generator, because the instructions for use incorrectly contained instructions supporting the sterilization of the MultiGen¿ cables.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Low (Class III)
Status Terminated
Recall number Z-0584-2017
Date reported November 23, 2016
Date initiated October 11, 2016
Recalling firm Stryker Instruments Div. of Stryker Corporation
Firm location Portage, MI
Affected scope 2,675
Distribution Domestic:AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY Foreign:France, Germany, Canad…

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

2,675 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-0584-2017) 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?
RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U. Recalled by Stryker Instruments Div. of Stryker Corporation. Units affected: 2,675.
Why was this product recalled?
Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen¿ Generator, because the instructions for use incorrectly contained instructions supporting the sterilization of the MultiGen¿ cables.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 23, 2016. Severity: Low. Recall number: Z-0584-2017.
Where was the recalled product distributed?
Distribution: Domestic:AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY Foreign:France, Germany, Canada, UK, Lebanon, South Africa, Chile, Hong Kong, Poland, Argentina, Spain, Greece, Italy, India, Brazil, Switzerland, Netherlands, Sweden VA/DOD:.
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-0584-2017) 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 23, 2016. 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.