Z-1569-2023Class II

Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for...

Name: Z-1569-2023 Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for...
Creator: Aesculap Implant Systems LLC
Published: 2023-03-21
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2023-03-21 / Open, Classified / root cause: design

FDA source

Aesculap Implant Systems LLC began a recall of Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including... on 2023-03-21. FDA classified it as Class II and gives the reason as "Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient's body". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1569-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-21
Posted: 2023-05-05
Recalling firm: Aesculap Inc
Product: Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery. Product Code: PL771SU
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient's body.
Root cause tag: design
FDA root cause: Device Design
Action: Aesculap Inc. issued via Urgent Medical Device Recall Notification Letter via U.S Postal Service, Certified Mail Return Receipt Requested/ USPS Priority Mail on 3/21/23. Letter states reason for recall, health risk and action to take: Review the Device Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and other concerned persons, are informed about this voluntary product recall. If you are a distributor, please forward this recall notification to your customers. The recall is to be extended to the end user/customer level. 2. Determine your current inventory of the affected lots within your facility, cease use and quarantine product subject to recall. Do not destroy any affected product. 3. Utilizing the attached Product Recall Acknowledgement Form, record the total number of individual units in your possession. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed Product Recall Acknowledgment Form form to the B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to [email protected] within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 5. Once we receive your Acknowledgement Form, an Aesculap Customer Support representative will contact you to arrange for credit and to have your current inventory returned. Should you identify a problem or safety concern with the product, please report the event promptly by contacting our Postmarket Surveillance Department at 1-833-425-1464.
Quantity in commerce: 6 pieces
Distribution: US Nationwide distribution in the state of OH.
Product codes and lots: UDI-DI: 04046964837340 Lot Number: 52785146

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1569-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1569-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-05

Product code GEI

K183180Class IICaiman 5 MarylandAesculap, Inc. / cleared 2019-03-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)