Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 4, 2012
Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA.: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Components within the Crossfire System that provided abrasion, resection, debridement and removal of bone and soft tissue through the Formula Shaver and blade, and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels through its SERFAS Energy electrosurgical probe.
Stryker Endoscopy determined that there may not have been adequate determination of required routine checks to ensure accuracy and fitness for use of specific serial numbers of Fo…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Stryker Endoscopy recalled Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx … - a moderate-severity action.
Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx … was recalled by Stryker Endoscopy in July 4, 2012. Reason: Stryker Endoscopy determined that there may not have been adequate determination of required routine checks t…. Check the official notice for the remedy. Verify recall #Z-1866-2012 with the FDA Devices before acting.
The recall
Stryker Endoscopy issued this moderate-severity FDA Devices recall-Stryker Endoscopy determined that there may not have been adequate determination of required routine checks t….
- Moderate
- severity level
- 34 units
- affected scope
- Class II
- classification
- July 4, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1866-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1866-2012) was formally reported on July 4, 2012, with the manufacturer initiating the action on May 21, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Stryker Endoscopy is listed as the recalling firm, operating out of San Jose, CA. Federal records list the affected scope as 34 devices.
The documented reason for this recall is: Stryker Endoscopy determined that there may not have been adequate determination of required routine checks to ensure accuracy and fitness for use of specific serial numbers of Formula and 180 Shaver Hand Control. Distribution data in the federal record shows the product reached: Worldwide distribution: USA (nationwide) including states of: CA, FL, IA , MI, NV, NC, OK, TX, and WI; and countries of: China and Great Britain.. 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
34 devices
Related Recalls
6
3 from same agency
Product description
Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA.: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Components within the Crossfire System that provided abrasion, resection, debridement and removal of bone and soft tissue through the Formula Shaver and blade, and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels through its SERFAS Energy electrosurgical probe.
Reason for recall
Stryker Endoscopy determined that there may not have been adequate determination of required routine checks to ensure accuracy and fitness for use of specific serial numbers of Formula and 180 Shaver Hand Control.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1866-2012 |
| Date reported | July 4, 2012 |
| Date initiated | May 21, 2012 |
| Recalling firm | Stryker Endoscopy |
| Firm location | San Jose, CA |
| Affected scope | 34 devices |
| Distribution | Worldwide distribution: USA (nationwide) including states of: CA, FL, IA , MI, NV, NC, OK, TX, and WI; and countries of: China and Great Britain. |
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-1866-2012) 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? ▼
Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA.: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Components within the Crossfire System that provided abrasion, resection, debridement and removal of bone and soft tissue through the Formula Shaver and blade, and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels through its SERFAS Energy electrosurgical probe.. Recalled by Stryker Endoscopy. Units affected: 34 devices.
Why was this product recalled? ▼
Stryker Endoscopy determined that there may not have been adequate determination of required routine checks to ensure accuracy and fitness for use of specific serial numbers of Formula and 180 Shaver Hand Control.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 4, 2012. Severity: Moderate. Recall number: Z-1866-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: USA (nationwide) including states of: CA, FL, IA , MI, NV, NC, OK, TX, and WI; and countries of: China and Great Britain..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1866-2012) 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 July 4, 2012. 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.