Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported December 20, 2017
LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.
The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Physio-Control, Inc. recalled LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The de… - a critical-severity action.
LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The de… was recalled by Physio-Control, Inc. in December 20, 2017. Reason: The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF…. Check the official notice for the remedy. Verify recall #Z-0186-2018 with the FDA Devices before acting.
The recall
Physio-Control, Inc. issued this critical-severity FDA Devices recall-The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF….
- Critical
- severity level
- 14K units
- affected scope
- Class I
- classification
- December 20, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0186-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0186-2018) was formally reported on December 20, 2017, with the manufacturer initiating the action on October 27, 2017. It is classified under Critical severity (Class I), with a current status of Terminated. Physio-Control, Inc. is listed as the recalling firm, operating out of Redmond, WA. Federal records list the affected scope as 14,219 units in total.
The documented reason for this recall is: The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols. Distribution data in the federal record shows the product reached: Worldwide distribution: US (nationwide) including Puerto Rico and Guam and countries of: Canada, Austria, Belgium, Czech Republic; Denmark, Finland, France, French Polynesia, Germany, Hungary, Ireland, Italy, Latvia, Ne…. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
14,219 units in total
Related Recalls
6
0 from same agency
Product description
LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.
Reason for recall
The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0186-2018 |
| Date reported | December 20, 2017 |
| Date initiated | October 27, 2017 |
| Recalling firm | Physio-Control, Inc. |
| Firm location | Redmond, WA |
| Affected scope | 14,219 units in total |
| Distribution | Worldwide distribution: US (nationwide) including Puerto Rico and Guam and countries of: Canada, Austria, Belgium, Czech Republic; Denmark, Finland, France, French Polynesia, Germany, Hungary, Ireland, Italy, Latvia, Netherlands, Australia… |
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-0186-2018) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.. Recalled by Physio-Control, Inc.. Units affected: 14,219 units in total.
Why was this product recalled? ▼
The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 20, 2017. Severity: Critical. Recall number: Z-0186-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: US (nationwide) including Puerto Rico and Guam and countries of: Canada, Austria, Belgium, Czech Republic; Denmark, Finland, France, French Polynesia, Germany, Hungary, Ireland, Italy, Latvia, Netherlands, Australia, China, Hong Kong, Japan, Argentina, Mexico, Norway, Panama, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, and New Zealand..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0186-2018) 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
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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 20, 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.