The B. Braun Infusomat Space pump has been the subject of Class I recalls in 2011 and 2012, for an anti-free-flow clip catch inside the door, and a Class I correction that began in September 2023 (FDA recall numbers Z-0123-2024 and Z-0124-2024) and was expanded in August 2024 (Z-2972-2024), for upstream occlusion sensors that could trigger false occlusion alarms on specific serial numbers. That correction is still listed as open; B. Braun’s field service replaces the affected sensors. Several Infusomat Space administration sets have also been recalled, including a November 2023 Class I correction for false air-in-line alarms. Pumps run either 686-series software (Versions E, F and G) or 586U software (Version U); check the start-up screen, then check your serial numbers against the notices below.
The Infusomat Space is made by B. Braun Melsungen AG in Germany and distributed in the U.S. by B. Braun Medical Inc. FDA first cleared it in 2006, and B. Braun announced FDA clearance of the second-generation pump, with wireless EMR integration and auto-programming, in 2015. This guide puts the pump-level recalls, the set recalls and the software versions in one place, in plain English, so your team can tell which pumps and supplies are affected and what to do next.
Infusomat Space Software Versions
Every Infusomat Space looks much the same from the outside. The software version determines which features the pump has, which manual applies and, for some notices, which instructions you follow. These are the versions named in FDA records and B. Braun documents:
| Version | Status | Notes |
|---|---|---|
| 686E (686E030003) | Earlier U.S. software | Listed among the affected versions in the 2012 Class I recall (terminated 2014). |
| 686F (686F030005, 686F030007), Version F | Earlier U.S. software | Listed among the affected versions in the 2012 Class I recall (terminated 2014). |
| 686G (686G030002, 686G030102, 686G030103 “G03”), Version G | Earlier U.S. software family | Named in the 2012 Class I recall (terminated 2014); G03 was the software in the remedy for the 2011 recall. B. Braun’s 2024 set correction still gave separate instructions for G-software pumps. |
| 586U, Version U | Current U.S. Instructions for Use | B. Braun’s current U.S. Instructions for Use are valid for 586U and cover wireless drug library upload and AutoProgramming. The Instructions for Use refer to U6, U10, U11, U12, U15 and later releases. |
| L | Canada only | Named, with U and G, in B. Braun’s June 2024 set correction, which gave workflow instructions that vary by pump software. |
The Instructions for Use recommend that all pumps at an institution run the same software version. Not sure what a version means for your fleet? Contact us with the version on the start-up screen and we will help you sort it out.
How to Check Your Infusomat Space Software Version
- Turn the pump on. The message Self-test active and the software version appear during the self-test.
- Or, from the Home screen, open the Status menu and scroll to the version.
- Note the serial number from the pump label; the 2023–2024 correction is tied to serial numbers, not software.
- Record the version and serial number for each pump in your asset system so you can act quickly on future notices.
Infusomat Space Pump Recalls
Class I is FDA’s most serious recall classification. These Class I recalls have involved the Infusomat Space pump itself:
| Initiated | FDA recall number | Affected | Issue | Remedy |
|---|---|---|---|---|
| July 2011 | Z-1015-2012 | Model 8713050U, listed serial numbers | If a set’s anti-free-flow clip was inserted incorrectly and the door forced closed, the clip catch inside the door could break; if the set was then removed without closing the roller clamp, the clip might not re-engage the tubing, leaving a free-flow path. | B. Braun letter (August 2011) on implementing G03 software; the affected hospitals were upgraded in November 2011. Terminated 2014. |
| March 2012 | Z-1992-2012 | Models 8713050U, 8713050U-99, 8713050US, 8713060U and 8713060U-99 on 686E, 686F and 686G software, including G03 | The anti-free-flow clip catch inside the door could break if a set clip was inserted incorrectly and the door forced closed; if the set was then removed without the roller clamp closed, free flow could occur. | Urgent Medical Device Correction letter; customers identified affected units and returned an acknowledgement form. Terminated 2014. |
| September 2023 | Z-0123-2024 | 8713051U (wireless), listed serial numbers, with more added in August 2024 | An upstream occlusion alarm could sound when no occlusion exists, stopping the infusion. | Field service to replace sensors; interim measures. Open. |
| September 2023 | Z-0124-2024 | 8713052U (non-wireless battery pack), listed serial numbers, with more added in August 2024 | Same upstream occlusion alarm issue. | Field service to replace sensors; interim measures. Open. |
| August 2024 | Z-2972-2024 | 8713050U, listed serial numbers. The same August 2024 update added serial numbers (pumps serviced with potentially affected sensors) to Z-0123-2024 and Z-0124-2024. | Expansion of the 2023 correction: the upstream occlusion sensor could stop working properly because of electrostatic charge buildup, causing false upstream and downstream occlusion alarms. | Field service to replace sensors; interim measures. Open. |
The 2011 and 2012 recalls are terminated. The occlusion sensor correction was still listed as open in FDA’s database when we checked in November 2026, so it is the one most fleets need to confirm today. If you checked your serial numbers against the 2023 lists, check them again against the August 2024 additions.
The 2023–2024 Occlusion Sensor Correction
On September 21, 2023, B. Braun sent Urgent Medical Device Correction letters for Infusomat Space Large Volume Pumps, wireless (8713051U) and non-wireless battery pack (8713052U), that FDA says were distributed from October 26, 2022 to July 17, 2023. On affected serial numbers, an upstream occlusion alarm could sound when no occlusion exists and stop delivery, including of high-risk medications such as vasopressors. FDA classified it as Class I, a correction rather than a removal, and reported 51 complaints, one injury and one death. FDA’s determined cause was component design and selection.
In August 2024, B. Braun expanded the correction to model 8713050U and to more serial numbers of the other two models: pumps that had been serviced with potentially affected sensors. FDA’s recall entry for the expansion (Z-2972-2024) attributes the false upstream and downstream occlusion alarms to electrostatic charge buildup on the upstream occlusion sensor.
What the notices tell customers to do:
- Identify affected units by serial number and mark them with the stickers B. Braun provides.
- Do not use affected pumps for high-risk medications; keep them in areas that do not give high-risk medications until the sensor is replaced.
- If an affected pump must be used for high-risk medications, keep a backup pump available and expect additional monitoring.
- Per the 2024 notice, power down any pump with frequent false alarms for 48 hours, then monitor it closely in a low-risk area.
- Return the Product Correction Acknowledgement Form within two weeks, even if you have no affected units; a B. Braun Field Service Representative then schedules the sensor replacement.
Because the affected units are defined by serial number, the manufacturer’s notice and response form are the authority on which pumps are included. Repeated occlusion alarms on a clear line can also come from ordinary sensor wear or fluid damage; our Infusomat Space common problems guide covers what we find when those pumps reach our lab.
Administration Set and Accessory Recalls
The Infusomat Space is intended for use only with dedicated Infusomat Space sets, so set recalls matter to every pump fleet. These recalls involve sets and accessories used with the pump:
| Initiated | FDA recall number | Class | Product and issue |
|---|---|---|---|
| March 2012 | Z-0623-2013 | II | Space Pole Clamp 8713130: the locking grids could break. B. Braun improved the locking mechanism and upgraded older-style clamps. Terminated 2015. |
| May 2018 | Z-2285-2018 | II | Space Pump IV Set 363420, one lot: a different set without the air-eliminating filter could be mixed into the lot. Terminated 2019. |
| May 2019 | Z-2489-2019 | I | Infusomat Space administration set 363032, one lot: possible leak or disconnection at the bonded joint between the tubing and the Y-site. Terminated 2020. |
| June 2021 | Z-2137-2021 | II | Infusomat Space set 490100, one lot: the anti-free-flow clip could be inverted, allowing free flow if the roller clamp is not closed before the set is removed. Terminated 2023. |
| November 2023 | Z-0355-2024 | I | Infusomat administration sets across 42 catalog numbers: tubing outer diameter could vary or the tubing could be too short, causing false air-in-line alarms that stop the infusion. Lots 0061902124 and higher were made to revised specifications. Open. |
| June 2024 | Z-2382-2024 and related entries | II | Infusomat Space pump sets with backcheck valves: the valve could let medication flow back from a secondary (piggyback) container into the primary container, or prevent priming. Interim measures include clamping the primary line above the upper Y-site during piggyback infusions, with workflow instructions that vary by pump software. Open. |
| October 2025 | Z-0640-2026 | II | Gravity and pump sets used with the Infusomat Space, Outlook and Vista Basic pumps: possible backflow from secondary into primary containers and inability to prime. Interim secondary-infusion measures. Open. |
Set recalls are tied to catalog and lot numbers. Check the FDA entries and B. Braun’s letters against your stock, and post any interim workflow instructions in care areas as directed.
What to Do Now: A Checklist for Biomed and HTM Teams
- Record the software version and serial number of every Infusomat Space in your fleet.
- Check serial numbers against the 2023–2024 occlusion sensor correction and confirm with B. Braun that affected pumps have had their sensors replaced.
- Until they have, keep affected pumps away from high-risk medications, as the notices direct.
- Check administration set stock against the November 2023 air-in-line correction, the June 2024 backcheck valve correction and the October 2025 backflow correction, and post the interim secondary-infusion instructions.
- Keep the fleet on one software version where you can, as the Instructions for Use recommend.
- Inspect pole clamps for damage or missing clamp grids.
- Check FDA’s recall database and B. Braun’s customer communications for anything newer than this guide.
How IPR Medical Can Help
Version guidance
We can check your pumps’ software versions and help you read the published notices. We update pump software as part of service; ask us about version upgrades.
Versions F, G and U
We repair Infusomat Space pumps across software versions in-house at our ISO 9001:2015-certified facility in Tustin, California.
Sensor, door and connector repairs
We repair door and latch assemblies, pressure and air-in-line sensor faults, batteries, keypads and displays. For serial numbers covered by B. Braun’s open occlusion sensor correction, the manufacturer’s sensor replacement is the remedy; contact B. Braun.
Free evaluation and shipping label
U.S. customers get a free inbound label and a free evaluation. Request a free label.
Need pumps instead? Shop recertified (refurbished) Infusomat Space Version U and Version G pumps, or find manuals in our Infusomat Space manuals guide. For repairs, see our B. Braun infusion pump repair service.
Infusomat Space Recall FAQ
Is the Infusomat Space recalled?
The Infusomat Space has been the subject of FDA Class I recalls in 2011, 2012 and 2023, the last expanded in 2024. The 2023–2024 action is a correction, not a removal: B. Braun replaces upstream occlusion sensors on specific serial numbers. It was still listed as open in FDA’s database in November 2026.
What is the Infusomat Space occlusion alarm recall?
In September 2023, B. Braun began a Class I correction (Z-0123-2024 and Z-0124-2024) because an upstream occlusion alarm could sound when no occlusion exists and stop the infusion on certain serial numbers of models 8713051U and 8713052U. In August 2024 it was expanded to model 8713050U (Z-2972-2024) and to more serial numbers of the first two models. B. Braun field service replaces the affected sensors.
How do I know if my Infusomat Space is affected by the occlusion correction?
The correction is defined by model and serial number, not by software version. Compare each pump’s serial number with the lists in B. Braun’s notices and FDA’s recall entries, and contact B. Braun to confirm whether the sensor replacement has been done.
What is the difference between Infusomat Space Version G and Version U?
The letters refer to software families. Version G pumps run 686G software, such as 686G030103 (G03); that software was named in a 2012 recall that was terminated in 2014. Version U pumps run 586U software, the version B. Braun’s current U.S. Instructions for Use cover, including wireless drug library upload and EHR AutoProgramming.
How do I check the software version on an Infusomat Space?
Turn the pump on; the version appears with the Self-test active message. You can also open the Status menu from the Home screen and scroll to the version.
Have Infusomat Space IV sets been recalled?
Yes. Several set lots and catalog numbers have been recalled, including a November 2023 Class I correction (Z-0355-2024) for tubing that could cause false air-in-line alarms, and a June 2024 correction for backcheck valves and an October 2025 correction, both for possible backflow from secondary into primary containers during piggyback infusions. Check your stock against the FDA entries.
Does IPR Medical repair recalled Infusomat Space pumps?
We repair Infusomat Space pumps on Versions F, G and U. For pumps covered by an open manufacturer correction, follow B. Braun’s notice for the remedy. Contact us about other service needs for your fleet.
Sources
- FDA recall database: Z-0123-2024 (September 2023, Class I, 8713051U)
- FDA recall database: Z-0124-2024 (September 2023, Class I, 8713052U)
- FDA recall database: Z-2972-2024 (August 2024, Class I, 8713050U)
- FDA notice: Infusomat Space Large Volume Pump occlusion alarm recall (2023)
- FDA notice: Infusomat Space correction expansion (2024)
- FDA recall database: Z-1015-2012 (July 2011, Class I)
- FDA recall database: Z-1992-2012 (March 2012, Class I, 686E/F/G software)
- FDA recall database: Z-0623-2013 (Space Pole Clamp)
- FDA recall database: Z-2285-2018 (set 363420)
- FDA recall database: Z-2489-2019 (set 363032, Class I)
- FDA recall database: Z-2137-2021 (set 490100)
- FDA recall database: Z-0355-2024 (administration sets, false air-in-line alarms, Class I)
- FDA recall database: Z-2382-2024 (backcheck valve sets, June 2024)
- FDA recall database: Z-0640-2026 (gravity and pump sets, October 2025)
- FDA 510(k) K142596: Infusomat Space Volumetric Infusion Pump (2015)
- B. Braun press release: FDA clearance of the second-generation Infusomat Space (September 2015)
- B. Braun: Infusomat Space Large Volume Pump, Wireless (Instructions for Use, Software U)
Not Sure Which of Your Pumps Are Affected?
Send us the serial numbers and software versions, or send the pumps in for a free evaluation. We will check them against the published notices and tell you what we can confirm; for notices tied to specific serial numbers or set lots, the manufacturer’s notice and response form list the affected units.
B. Braun, Infusomat, Perfusor, Outlook and Vista are trademarks of their respective owners, including B. Braun Melsungen AG and its affiliates, and are used here only to identify the original manufacturer’s equipment and products. IPR Medical is an ISO 9001:2015-certified independent service organization and is not sponsored by, affiliated with, or endorsed by B. Braun or any other original equipment manufacturer. All other product names and trademarks are the property of their respective owners and are used only to identify those owners’ products; IPR Medical is not sponsored by, affiliated with, or endorsed by any of these trademark owners. This guide summarizes public FDA and manufacturer information for convenience; it is not a substitute for the manufacturer’s notices. Always follow the most current instructions from the manufacturer and FDA.