Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 19, 2014
Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healthcare CosyCot and Kit Replacement Head Case Assembly It is designed to assist with the thermoregulation of infants weighing up to 10kg and is used by labor and delivery rooms and pediatric intensive care units. Infant Warmers Model Number (REF) IW910XXX, IW920XXX, IW931XXX, IW932XXX, IW933XXX, IW934XXX, IW951XXX, IW952XXX, IW953XXX, IW954XXX, IW980XXX, IW990XXX Spare Parts Model Number (REF) 04304
Breakage of the nut that secures the heater head in place, which can cause the heater head to become partially detached and swing towards the bassinet. There is the potential that…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Fisher & Paykel Healthcare, Ltd. recalled Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healt… - a moderate-severity action.
Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healt… was recalled by Fisher & Paykel Healthcare, Ltd. in November 19, 2014. Reason: Breakage of the nut that secures the heater head in place, which can cause the heater head to become partiall…. Check the official notice for the remedy. Verify recall #Z-0210-2015 with the FDA Devices before acting.
The recall
Fisher & Paykel Healthcare, Ltd. issued this moderate-severity FDA Devices recall-Breakage of the nut that secures the heater head in place, which can cause the heater head to become partiall….
- Moderate
- severity level
- Class II
- classification
- November 19, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0210-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0210-2015) was formally reported on November 19, 2014, with the manufacturer initiating the action on November 6, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Fisher & Paykel Healthcare, Ltd. is listed as the recalling firm, operating out of Auckland. Federal records list the affected scope as Nationwide (U.S.): 661 Infant Warmers and 180 Spare Parts, Internationally: 2,451 Infant Warmers and 280 Spare Parts.
The documented reason for this recall is: Breakage of the nut that secures the heater head in place, which can cause the heater head to become partially detached and swing towards the bassinet. There is the potential that a heater head could contact a patient s… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and Internationally to Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Bekgium, Bermuda, Chile, China, Croatia, Dominican Republic, Estonia, Finland, France, Germany,…. 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
Nationwide (U.S.): 661 Infant Warmers and 180 Spare Parts, Internationally: 2,451 Infant Warmers and 280 Spare Parts
Related Recalls
6
3 from same agency
Product description
Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healthcare CosyCot and Kit Replacement Head Case Assembly It is designed to assist with the thermoregulation of infants weighing up to 10kg and is used by labor and delivery rooms and pediatric intensive care units. Infant Warmers Model Number (REF) IW910XXX, IW920XXX, IW931XXX, IW932XXX, IW933XXX, IW934XXX, IW951XXX, IW952XXX, IW953XXX, IW954XXX, IW980XXX, IW990XXX Spare Parts Model Number (REF) 043041129, 043041130, 043041131, 043042359, 648040142
Reason for recall
Breakage of the nut that secures the heater head in place, which can cause the heater head to become partially detached and swing towards the bassinet. There is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0210-2015 |
| Date reported | November 19, 2014 |
| Date initiated | November 6, 2014 |
| Recalling firm | Fisher & Paykel Healthcare, Ltd. |
| Firm location | Auckland |
| Affected scope | Nationwide (U.S.): 661 Infant Warmers and 180 Spare Parts, Internationally: 2,451 Infant Warmers and 280 Spare Parts |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Bekgium, Bermuda, Chile, China, Croatia, Dominican Republic, Estonia, Finland, France, Germany, Great Britain, Gree… |
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-0210-2015) 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? ▼
Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healthcare CosyCot and Kit Replacement Head Case Assembly It is designed to assist with the thermoregulation of infants weighing up to 10kg and is used by labor and delivery rooms and pediatric intensive care units. Infant Warmers Model Number (REF) IW910XXX, IW920XXX, IW931XXX, IW932XXX, IW933XXX, IW934XXX, IW951XXX, IW952XXX, IW953XXX, IW954XXX, IW980XXX, IW990XXX Spare Parts Model Number (REF) 043041129, 043041130, 043041131, 043042359, 648040142. Recalled by Fisher & Paykel Healthcare, Ltd.. Units affected: Nationwide (U.S.): 661 Infant Warmers and 180 Spare Parts, Internationally: 2,451 Infant Warmers and 280 Spare Parts.
Why was this product recalled? ▼
Breakage of the nut that secures the heater head in place, which can cause the heater head to become partially detached and swing towards the bassinet. There is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 19, 2014. Severity: Moderate. Recall number: Z-0210-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Bekgium, Bermuda, Chile, China, Croatia, Dominican Republic, Estonia, Finland, France, Germany, Great Britain, Greece, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mauritius, Mexico. Morocco, New Zealand, Nigeria, Northern Ireland, Norway, Pakistan, Palestinian Territory, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, singapore, Slovenia, South Africa, Spain, Sri Lanka, Sultanate of Oman, Syria, Taiwan, Thailand, The Netherlands, Tunisia, Turkey, United Arab Emirates, Uruguay, Venezuela, Vietnam, and West Bank..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0210-2015) 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 November 19, 2014. 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.