Welch Allyn CP150 Electrocardiograph:
FDA Device Recall #Z-1560-2025 - Class II, March 24, 2025
Recall Summary
| Recall Number | Z-1560-2025 |
| Classification | Class II - Moderate risk |
| Date Initiated | March 24, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Baxter Healthcare Corporation |
| Location | Deerfield, IL |
| Product Type | Devices |
| Quantity | 41,739 units |
Product Description
Welch Allyn CP150 Electrocardiograph:
Reason for Recall
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
Distribution Pattern
Worldwide - US Nationwide distribution.
Lot / Code Information
All Serial Numbers. Product Code: CP150-2ES2, UDI-DI: 00732094192131; Product Code: CP150-2FR2, UDI-DI: 00732094192124; Product Code: CP150-2FR5, UDI-DI: 00732094192117; Product Code: CP150-2NL2, UDI-DI: 00732094192100; Product Code: CP150-2PT2, UDI-DI: 00732094192087; Product Code: CP150-2SV2, UDI-DI: 00732094192070; Product Code: CP150-3ENB, UDI-DI: 00732094179705; Product Code: CP150-3ESB, UDI-DI: 00732094179682; Product Code: CP150-4DE2, UDI-DI: 00732094192063; Product Code: CP150-4EN2, UDI-DI: 00732094179675; Product Code: CP150-4EN4, UDI-DI: 00732094179668; Product Code: CP150-4PT2, UDI-DI: 00732094192025; Product Code: CP150A-1EN2, UDI-DI: 00732094185157; Product Code: CP150A-1EN4, UDI-DI: 00732094185140; Product Code: CP150A-1EN66, UDI-DI: 00732094179644; Product Code: CP150A-1ENB, UDI-DI: 00732094177633; Product Code: CP150A-1ENBR, UDI-DI: 00732094322415; Product Code: CP150A-1ESB, UDI-DI: 00732094192230; Product Code: CP150A-1FRB, UDI-DI: 00732094179637; Product Code: CP150A-2DE2, UDI-DI: 00732094192018; Product Code: CP150A-2DE5, UDI-DI: 00732094192001; Product Code: CP150A-2EN2, UDI-DI: 00732094177626; Product Code: CP150A-2EN3, UDI-DI: 00732094179620; Product Code: CP150A-2EN4, UDI-DI: 00732094177619; Product Code: CP150A-2EN7, UDI-DI: 00732094191998; Product Code: CP150A-2ES2, UDI-DI: 00732094191981; Product Code: CP150A-2FR2, UDI-DI: 00732094191974; Product Code: CP150A-2FR5, UDI-DI: 00732094191967; Product Code: CP150A-2NL2, UDI-DI: 00732094191950; Product Code: CP150A-2NO2, UDI-DI: 00732094191943; Product Code: CP150A-2SV2, UDI-DI: 00732094191929; Product Code: CP150A-3BPZ, UDI-DI: 00732094212938; Product Code: CP150A-3EN2, UDI-DI: 00732094179613; Product Code: CP150A-3EN3, UDI-DI: 00732094179606; Product Code: CP150A-3EN4, UDI-DI: 00732094184815; Product Code: CP150A-3ENB, UDI-DI: 00732094179590; Product Code: CP150A-3ES2, UDI-DI: 00732094179583; Product Code: CP150A-3ESB, UDI-DI: 00732094177602; Product Code: CP150A-3ZHC-CN, UDI-DI: 00732094213515; Product Code: CP150A-4BPZ, UDI-DI: 00732094212952; Product Code: CP150A-4DE2, UDI-DI: 00732094191912; Product Code: CP150A-4EN2, UDI-DI: 00732094177596; Product Code: CP150A-4EN4, UDI-DI: 00732094177589; Product Code: CP150A-4ES2, UDI-DI: 00732094177572; Product Code: CP150A-4FR5, UDI-DI: 00732094189186; Product Code: CP150A-4PT2, UDI-DI: 00732094189179; Product Code: CP150A-4ZHC-CN, UDI-DI: 00732094213539; Product Code: CP150AD-1ENB, UDI-DI: 00732094237580; Product Code: CP150AD-2DE2, UDI-DI: 00732094237573; Product Code: CP150AD-2ES2, UDI-DI: 00732094237559; Product Code: CP150ADS-1EN66, UDI-DI: 00732094242171; Product Code: CP150AS-1EN66, UDI-DI: 00732094333244; Product Code: CP150AS-1ENB, UDI-DI: 00732094185133; Product Code: CP150AW-1EN66, UDI-DI: 00732094237511; Product Code: CP150-2EN7, UDI-DI: 00732094192148; Product Code: CP150-1EN2, UDI-DI: 00732094185171; Product Code: CP150-1EN66, UDI-DI: 00732094179750; Product Code: CP150-1ENB, UDI-DI: 00732094177640; Product Code: CP150-1FRB, UDI-DI: 00732094192254; Product Code: CP150-2DE2, UDI-DI: 00732094192162; Product Code: CP150-2EN2, UDI-DI: 00732094179743; Product Code: CP150-2EN4, UDI-DI: 00732094179729; Product Code: CP150AW-1ENB, UDI-DI: 00732094237504; Product Code: CP150AW-2DE2, UDI-DI: 00732094237498; Product Code: CP150AW-2EN4, UDI-DI: 00732094237481; Product Code: CP150AW-2ES2, UDI-DI: 00732094237474; Product Code: CP150AW-2NL2, UDI-DI: 00732094237467; Product Code: CP150AW-3ENB, UDI-DI: 00732094242003; Product Code: CP150AWD-1EN66, UDI-DI: 00732094237436; Product Code: CP150AWD-1ENB, UDI-DI: 00732094237429; Product Code: CP150AWD-2DE2, UDI-DI: 00732094237412; Product Code: CP150AWD-2EN4, UDI-DI: 00732094237405; Product Code: CP150AWD-2ES2, UDI-DI: 00732094237399; Product Code: CP150AWD-2NL2, UDI-DI: 00732094237382; Product Code: CP150AWD-4EN4, UDI-DI: 00732094237368; Product Code: CP150AWDS-1ENB, UDI-DI: 00732094241686; Product Code: CP150AWDS-3ENB, UDI-DI: 00732094241662; Product Code: CP150AWS-1ENB, UDI-DI: 00732094243437; Product Code: CP150S-1ENB, UDI-DI: 00732094222302; Product Code: CP150W-1ENB, UDI-DI: 00732094232837;
Other Recalls from Baxter Healthcare Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2551-2026 | Class I | Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Singl... | May 21, 2026 |
| Z-2549-2026 | Class I | Hillrom VOLARA P.CIRCUIT 5KIT (System Single Pa... | May 21, 2026 |
| Z-2548-2026 | Class I | Hillrom VOLARA System P.CIRCUIT KIT (Single Pat... | May 21, 2026 |
| Z-2550-2026 | Class I | Hillrom VOLARA System P.CIRCUIT KIT AC (Single ... | May 21, 2026 |
| Z-2262-2026 | Class II | Brand Name: Exacta Mix Product Name: Vented Mi... | Apr 22, 2026 |
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery, the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.