Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 3, 2016
Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled. Product Usage: Babytherm 8004/8010 is an open care infant warmer system for warming premature babies, neonates and infants with a body weight of up to 8 kg (17.6 lbs). The device is intended for use in delivery rooms, operating rooms, maternity and obstetric units, neonatal and pediatric wards, neonatal and pediatric intensive car
Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Draeger Medical, Inc. recalled Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Ba… - a moderate-severity action.
Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Ba… was recalled by Draeger Medical, Inc. in August 3, 2016. Reason: Risk associated with operating the device in skin temperature mode with temperature sensors attached but no p…. Check the official notice for the remedy. Verify recall #Z-2295-2016 with the FDA Devices before acting.
The recall
Draeger Medical, Inc. issued this moderate-severity FDA Devices recall-Risk associated with operating the device in skin temperature mode with temperature sensors attached but no p….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- August 3, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2295-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2295-2016) was formally reported on August 3, 2016, with the manufacturer initiating the action on June 22, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Draeger Medical, Inc. is listed as the recalling firm, operating out of Telford, PA. Federal records list the affected scope as 1,599 units.
The documented reason for this recall is: Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected. Distribution data in the federal record shows the product reached: US Nationwide Distribution including Puerto Rico and the states of AK,AL,AR,CA,CO,CT,DE,FL,GA,HI,IA,IL,IN,KS,KY,LA,MA,MD,MI,MN,MO,MS,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,TN,TS,TX,UT,VA,WA,WI,WV, and WY.. 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
1,599 units
Related Recalls
6
3 from same agency
Product description
Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled. Product Usage: Babytherm 8004/8010 is an open care infant warmer system for warming premature babies, neonates and infants with a body weight of up to 8 kg (17.6 lbs). The device is intended for use in delivery rooms, operating rooms, maternity and obstetric units, neonatal and pediatric wards, neonatal and pediatric intensive care units. Therapy and nursing uses: - As a resuscitation table and in birthing rooms, obstetric units, and NICUs - As infant warmer bassinet during normal and intensive care - For infant re-warming and compensation of heat loss - For thermal stabilizing of infants with mattress heater (Babytherm 8010 only) - For gentle warming therapy using the combination of radiant and mattress heater - Cooling infants with fever (temperature of mattress below infant body temperature, Babytherm 8010 only) - With adjustable bed tilt for treatment of infants in Trendelenburg and reverse Trendelenburg position - For weaning infants from incubators - For O2 and nebulizer therapy (with appropriate accessories) - For lowering an infant s bilirubin levels when using the phototherapy option
Reason for recall
Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2295-2016 |
| Date reported | August 3, 2016 |
| Date initiated | June 22, 2016 |
| Recalling firm | Draeger Medical, Inc. |
| Firm location | Telford, PA |
| Affected scope | 1,599 units |
| Distribution | US Nationwide Distribution including Puerto Rico and the states of AK,AL,AR,CA,CO,CT,DE,FL,GA,HI,IA,IL,IN,KS,KY,LA,MA,MD,MI,MN,MO,MS,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,TN,TS,TX,UT,VA,WA,WI,WV, and WY. |
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-2295-2016) 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? ▼
Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled. Product Usage: Babytherm 8004/8010 is an open care infant warmer system for warming premature babies, neonates and infants with a body weight of up to 8 kg (17.6 lbs). The device is intended for use in delivery rooms, operating rooms, maternity and obstetric units, neonatal and pediatric wards, neonatal and pediatric intensive care units. Therapy and nursing uses: - As a resuscitation table and in birthing rooms, obstetric units, and NICUs - As infant warmer bassinet during normal and intensive care - For infant re-warming and compensation of heat loss - For thermal stabilizing of infants with mattress heater (Babytherm 8010 only) - For gentle warming therapy using the combination of radiant and mattress heater - Cooling infants with fever (temperature of mattress below infant body temperature, Babytherm 8010 only) - With adjustable bed tilt for treatment of infants in Trendelenburg and reverse Trendelenburg position - For weaning infants from incubators - For O2 and nebulizer therapy (with appropriate accessories) - For lowering an infant s bilirubin levels when using the phototherapy option. Recalled by Draeger Medical, Inc.. Units affected: 1,599 units.
Why was this product recalled? ▼
Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 3, 2016. Severity: Moderate. Recall number: Z-2295-2016.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution including Puerto Rico and the states of AK,AL,AR,CA,CO,CT,DE,FL,GA,HI,IA,IL,IN,KS,KY,LA,MA,MD,MI,MN,MO,MS,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,TN,TS,TX,UT,VA,WA,WI,WV, and WY..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2295-2016) 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 August 3, 2016. 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.