Physio-Control Recalls Defibrillation Electrodes Due to Incorrect Pad Placement Artwork
Physio-Control is recalling 14,219 LIFEPAK defibrillation electrodes because the artwork instructs incorrect pad placement and is missing required warning symbols.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low probability of adverse health consequences. The hazard involves incorrect labeling and missing warning symbols rather than a direct mechanical failure or contamination, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Physio-Control, Inc. is recalling 14,219 units of LIFEPAK defibrillation electrodes (Catalog # 11101-000016, MIN #3202380-006). The recall is due to a labeling error where the infant artwork on the product instructs incorrect pad placement. Additionally, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.
The affected electrodes are used only with LIFEPAK EXPRESS AED, LIFEPAK CR Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AEDs with a pink connector. The units were distributed worldwide, including the United States (nationwide, Puerto Rico, and Guam) and numerous international locations such as Canada, the United Kingdom, Germany, and Japan.
Consumers and healthcare facilities should check their inventory for the specific catalog and MIN numbers listed above. If the product matches the description, it should be removed from service and returned to Physio-Control, Inc. according to their instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Physio-Control, Inc.
- Affected units
- 14,219
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 713609
- 717912
- 713904
- 718033
- 715008
- 719323
Distribution
Part of a larger recall action
This product is one of 2 recalled by Physio-Control, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Physio-Control, Inc.
See all →- HighPhysio-Control Defibrillators May Lack Required Performance Inspection
FDA (Devices) · 2026-05-13
- HighInfant and child defibrillator electrodes recalled over pediatric electrode delamination
FDA (Devices) · 2026-03-18
- ModerateDefibrillator recalled because required post-service inspections were not performed
FDA (Devices) · 2025-09-10
- ModerateLIFEPAK 15 defibrillators recalled because post-service inspections were not performed
FDA (Devices) · 2025-09-10
- ModerateLIFEPAK 1000 defibrillators recalled over inspections missed after unit servicing
FDA (Devices) · 2025-09-10
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02