Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 21, 2021
Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: used with both the SPY-PHI and PINPOINT systems, the intended use for both imaging systems are being documented here.
Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Stryker Corporation recalled Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical De… - a moderate-severity action.
Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical De… was recalled by Stryker Corporation in April 21, 2021. Reason: Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended re…. Check the official notice for the remedy. Verify recall #Z-1428-2021 with the FDA Devices before acting.
The recall
Stryker Corporation issued this moderate-severity FDA Devices recall-Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended re….
- Moderate
- severity level
- 125 units
- affected scope
- Class II
- classification
- April 21, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1428-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1428-2021) was formally reported on April 21, 2021, with the manufacturer initiating the action on February 26, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Stryker Corporation is listed as the recalling firm, operating out of San Jose, CA. Federal records list the affected scope as 125 units.
The documented reason for this recall is: Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IL, MA MI, MS NC, NV, OK, PA, SC, TN, TX, VA, WA, WI and the countries of AE, CA, CN, CZ, DE, ES, HK, JP, KR, KW, MX, MY, PH, RO…. 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
125 units
Related Recalls
6
3 from same agency
Product description
Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: used with both the SPY-PHI and PINPOINT systems, the intended use for both imaging systems are being documented here.
Reason for recall
Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1428-2021 |
| Date reported | April 21, 2021 |
| Date initiated | February 26, 2021 |
| Recalling firm | Stryker Corporation |
| Firm location | San Jose, CA |
| Affected scope | 125 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IL, MA MI, MS NC, NV, OK, PA, SC, TN, TX, VA, WA, WI and the countries of AE, CA, CN, CZ, DE, ES, HK, JP, KR, KW, MX, MY, PH, RO, SG, TR, TW. |
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-1428-2021) 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? ▼
Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: used with both the SPY-PHI and PINPOINT systems, the intended use for both imaging systems are being documented here.. Recalled by Stryker Corporation. Units affected: 125 units.
Why was this product recalled? ▼
Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 21, 2021. Severity: Moderate. Recall number: Z-1428-2021.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IL, MA MI, MS NC, NV, OK, PA, SC, TN, TX, VA, WA, WI and the countries of AE, CA, CN, CZ, DE, ES, HK, JP, KR, KW, MX, MY, PH, RO, SG, TR, TW..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1428-2021) 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 April 21, 2021. 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.