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Use caution Medical device recall · FDA · Published February 19, 2021

Aesculap Universal Robot UR5 Arm Recall: Robotic Arm Malfunction Risk

Aesculap recalls Universal Robot UR5 arm (PV010204) for potential robotic arm malfunction causing system restarts. Affected units have specific UDI-DI and serial numbers.

🇺🇸 FDA recall #Z-1409-2022Medical deviceAesculap ›
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Contact the company

Recalling firmAesculap Implant Systems LLC3773 Corporate Pkwy · Center Valley, PA 18034-8217
✎ GovInfoNow plain-language explainer

Aesculap is recalling a specific robotic arm component used in their digital microscope system due to a malfunction risk that could require restarting the system. This affects medical devices that may cause operational interruptions during use. Read more at govinfonow.com/recall/63257-aesculap-universal-robot-ur5-arm-recall-robotic-arm-malfunction-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63257-aesculap-universal-robot-ur5-arm-recall-robotic-arm-malfunction-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1409-2022

Cite this page

“Aesculap Universal Robot UR5 Arm Recall: Robotic Arm Malfunction Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63257-aesculap-universal-robot-ur5-arm-recall-robotic-arm-malfunction-risk. Based on FDA recall #Z-1409-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1409-2022%22&limit=1).

Aesculap Implant Systems LLC recalled one Universal Robot UR5 arm with PV010204 subcomponent on Feb. 19, 2021, according to the FDA. The device may malfunction, preventing further movement and requiring a system restart.

How to tell if you have it

  • Brand: Aesculap
  • Product: Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System
  • UDI-DI: 04046955206742
  • Serial Number: SN1004
  • Quantity: 1 unit
  • Distribution: United States (NE)

The hazard

The recall involves a malfunction of the robotic arm that prevents further movement and requires restarting the robotic digital microscope system, according to the FDA.

Context

GovInfoNow's records show Aesculap Implant Systems LLC has 26 other recalls on record since Aug. 10, 2017. Other recent recalls of similar products include Aesculap MINOP Trocar 150mm Recall (Jan. 15, 2026), Medline Thoracic Robots Recall (Feb. 16, 2026) and Da Vinci X and Xi Surgical Systems Recall (April 2, 2026).

How to tell if you have this one

Check for the Universal Robot UR5 arm with serial number SN1004 and UDI-DI code 0404695:206742. This component is part of the Aesculap Aeos Digital Microscope System.

  • Brand
    Aesculap
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify your Universal Robot UR5 arm has serial number SN1004 and UDI-DI code 04046955206742.

Where it went and when

Where it was distributed

Distributed in Nebraska.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: yesNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “United States: NE” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Nebraska.

Recall timeline

FDA published this recall 17 months after the firm started it.

1. Firm started the recall: Feb 19, 202112. FDA classified it Class II: Jul 19, 202223. Published in FDA’s Enforcement Report: Jul 27, 2022320212022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1409-2022 (February 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1409-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA