Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 22, 2017
.045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. These guide wires are an orthopedic manual surgical instrument.
Guide wires sized as .045 X 6 were mis-packaged as .054 X 7 guide wires and those sized as .054 X 7 were mis- packaged as .045 X 6 guide wires. There is a possibility that using …
Acumed LLC recalled .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 i… - a moderate-severity action.
.045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 i… was recalled by Acumed LLC in March 22, 2017. Reason: Guide wires sized as .045 X 6 were mis-packaged as .054 X 7 guide wires and those sized as .054 X 7 were mis-…. Check the official notice for the remedy. Verify recall #Z-1483-2017 with the FDA Devices before acting.
The recall
Acumed LLC issued this moderate-severity FDA Devices recall-Guide wires sized as .045 X 6 were mis-packaged as .054 X 7 guide wires and those sized as .054 X 7 were mis-….
- Moderate
- severity level
- 24 units
- affected scope
- Class II
- classification
- March 22, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1483-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1483-2017) was formally reported on March 22, 2017, with the manufacturer initiating the action on February 17, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Acumed LLC is listed as the recalling firm, operating out of Hillsboro, OR. Federal records list the affected scope as 24 units of .045 X 6 ST Guide Wire and 25 units of .054 X 7 ST Guide Wire.
The documented reason for this recall is: Guide wires sized as .045 X 6 were mis-packaged as .054 X 7 guide wires and those sized as .054 X 7 were mis- packaged as .045 X 6 guide wires. There is a possibility that using the incorrect guide wire size can cause … Distribution data in the federal record shows the product reached: Worldwide Distribution in Great Britain, Ireland, and Japan only.. 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
24 units of .045 X 6 ST Guide Wire and 25 units of .054 X 7 ST Guide Wire
Related Recalls
6
3 from same agency
Product description
.045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. These guide wires are an orthopedic manual surgical instrument.
Reason for recall
Guide wires sized as .045 X 6 were mis-packaged as .054 X 7 guide wires and those sized as .054 X 7 were mis- packaged as .045 X 6 guide wires. There is a possibility that using the incorrect guide wire size can cause health hazards, such as mal or nonunion, need for revision surgery, and histological response (if wire breaks).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1483-2017 |
| Date reported | March 22, 2017 |
| Date initiated | February 17, 2017 |
| Recalling firm | Acumed LLC |
| Firm location | Hillsboro, OR |
| Affected scope | 24 units of .045 X 6 ST Guide Wire and 25 units of .054 X 7 ST Guide Wire |
| Distribution | Worldwide Distribution in Great Britain, Ireland, and Japan only. |
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-1483-2017) 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? ▼
.045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. These guide wires are an orthopedic manual surgical instrument.. Recalled by Acumed LLC. Units affected: 24 units of .045 X 6 ST Guide Wire and 25 units of .054 X 7 ST Guide Wire.
Why was this product recalled? ▼
Guide wires sized as .045 X 6 were mis-packaged as .054 X 7 guide wires and those sized as .054 X 7 were mis- packaged as .045 X 6 guide wires. There is a possibility that using the incorrect guide wire size can cause health hazards, such as mal or nonunion, need for revision surgery, and histological response (if wire breaks).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 22, 2017. Severity: Moderate. Recall number: Z-1483-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution in Great Britain, Ireland, and Japan only..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1483-2017) 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 March 22, 2017. 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.