FDA Medical Device Recalls (openFDA)
Aesculap Implant Systems LLC: 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
- Recall number
- Z-1569-2023
- Recalling firm
- Aesculap Implant Systems LLC
- 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
- Status
- Open, Classified
- Initiated
- 2023-03-21
- Posted
- 2023-05-05
- Terminated
- not on file
- Reason
- 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
- 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 PA_QualityAssurance.BBMUS_Service@bbraunusa.com 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
- 6 pieces
- Distribution
- US Nationwide distribution in the state of OH.
- Lot, serial or model codes
- UDI-DI: 04046964837340 Lot Number: 52785146
- 510(k) numbers
- ["K183180"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28