Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported May 9, 2018
HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), CAP610 (b) Elasto-Gel(TM), CAP610LV (c) Elasto-Gel(TM), CAP613 (d) Elasto-Gel(TM), CAP617 (e) Elasto-Gel(TM), CAP619 (f) Elasto-Gel(TM), CAP619LV (g) Elasto-Gel(TM), CAP622
Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during chemotherapy treatments. Additionally, Southwest Technologies, Inc. was …
Southwest Technologies Inc recalled HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) Elasto-Ge… - a moderate-severity action.
HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) Elasto-Ge… was recalled by Southwest Technologies Inc in May 9, 2018. Reason: Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during che…. Check the official notice for the remedy. Verify recall #Z-1600-2018 with the FDA Devices before acting.
The recall
Southwest Technologies Inc issued this moderate-severity FDA Devices recall-Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during che….
- Moderate
- severity level
- 16K units
- affected scope
- Class II
- classification
- May 9, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1600-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1600-2018) was formally reported on May 9, 2018, with the manufacturer initiating the action on December 28, 2017. It is classified under Moderate severity (Class II), with a current status of Ongoing. Southwest Technologies Inc is listed as the recalling firm, operating out of Kansas City, MO. Federal records list the affected scope as 15666 units.
The documented reason for this recall is: Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during chemotherapy treatments. Additionally, Southwest Technologies, Inc. was informed of 2 events of frostbite to dig… Distribution data in the federal record shows the product reached: worldwide. 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
15666 units
Related Recalls
6
3 from same agency
Product description
HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), CAP610 (b) Elasto-Gel(TM), CAP610LV (c) Elasto-Gel(TM), CAP613 (d) Elasto-Gel(TM), CAP617 (e) Elasto-Gel(TM), CAP619 (f) Elasto-Gel(TM), CAP619LV (g) Elasto-Gel(TM), CAP622
Reason for recall
Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during chemotherapy treatments. Additionally, Southwest Technologies, Inc. was informed of 2 events of frostbite to digits in the last year while using the hypothermia mitts.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1600-2018 |
| Date reported | May 9, 2018 |
| Date initiated | December 28, 2017 |
| Recalling firm | Southwest Technologies Inc |
| Firm location | Kansas City, MO |
| Affected scope | 15666 units |
| Distribution | worldwide |
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-1600-2018) 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? ▼
HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), CAP610 (b) Elasto-Gel(TM), CAP610LV (c) Elasto-Gel(TM), CAP613 (d) Elasto-Gel(TM), CAP617 (e) Elasto-Gel(TM), CAP619 (f) Elasto-Gel(TM), CAP619LV (g) Elasto-Gel(TM), CAP622. Recalled by Southwest Technologies Inc. Units affected: 15666 units.
Why was this product recalled? ▼
Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during chemotherapy treatments. Additionally, Southwest Technologies, Inc. was informed of 2 events of frostbite to digits in the last year while using the hypothermia mitts.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 9, 2018. Severity: Moderate. Recall number: Z-1600-2018.
Where was the recalled product distributed? ▼
Distribution: worldwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1600-2018) 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.
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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 May 9, 2018. 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.