Severity
Low
LowClass IIIOngoing
FDA Devices recall · Reported December 13, 2017
Arctic Sun ArcticGel Pads - Medium, Product Code 317-07
Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled with product code 317-…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
C.r. Bard, Inc. recalled Arctic Sun ArcticGel Pads - Medium, Product Code 317-07 - a low-severity action.
Arctic Sun ArcticGel Pads - Medium, Product Code 317-07 was recalled by C.r. Bard, Inc. in December 13, 2017. Reason: Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the …. Check the official notice for the remedy. Verify recall #Z-0590-2018 with the FDA Devices before acting.
The recall
C.r. Bard, Inc. issued this low-severity FDA Devices recall-Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the ….
- Low
- severity level
- 128 units
- affected scope
- Class III
- classification
- December 13, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0590-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0590-2018) was formally reported on December 13, 2017, with the manufacturer initiating the action on June 2, 2017. It is classified under Low severity (Class III), with a current status of Ongoing. C.r. Bard, Inc. is listed as the recalling firm, operating out of Covington, GA. Federal records list the affected scope as 128 units.
The documented reason for this recall is: Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled with product code 317-07 and lot number NDAR0462. Distribution data in the federal record shows the product reached: Distributed domestically. Distributed internationally to Australia and Belgium.. 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 - 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 - 40,422 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
128 units
Related Recalls
6
0 from same agency
Product description
Arctic Sun ArcticGel Pads - Medium, Product Code 317-07
Reason for recall
Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled with product code 317-07 and lot number NDAR0462.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | Z-0590-2018 |
| Date reported | December 13, 2017 |
| Date initiated | June 2, 2017 |
| Recalling firm | C.r. Bard, Inc. |
| Firm location | Covington, GA |
| Affected scope | 128 units |
| Distribution | Distributed domestically. Distributed internationally to Australia and Belgium. |
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-0590-2018) 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? ▼
Arctic Sun ArcticGel Pads - Medium, Product Code 317-07. Recalled by C.r. Bard, Inc.. Units affected: 128 units.
Why was this product recalled? ▼
Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled with product code 317-07 and lot number NDAR0462.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 13, 2017. Severity: Low. Recall number: Z-0590-2018.
Where was the recalled product distributed? ▼
Distribution: Distributed domestically. Distributed internationally to Australia and Belgium..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0590-2018) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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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 December 13, 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.