Z-1899-2025Class II

Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical...

Name: Z-1899-2025 Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical...
Creator: Silex Medical, LLC
Published: 2024-01-09
License: https://open.fda.gov/license/

Silex Medical, LLC / initiated 2024-01-09 / Open, Classified / root cause: manufacturing process

FDA source

Silex Medical, LLC began a recall of Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5864000 on 2024-01-09. FDA classified it as Class II and gives the reason as "Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1899-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-09
Posted: 2025-06-02
Recalling firm: Silex Medical, LLC
Product: Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5864000.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Silex formally notified customers on 01/09/2024. Instructions to consignees included to inspect all instruments that they received from the affected lots for the defect. If any instruments had the issue, the customers were instructed to send it back to their facility under an RGA.
Quantity in commerce: 105 units
Distribution: US Nationwide distribution in the states of Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, Hawaii.
Product codes and lots: Model/REF Number: 5864000. UDI-DI: B33158640000. Lot Number: M28187. Serial Numbers: 9565, 9566, 9567, 9568, 9569, 9570, 9571, 9572, 9573, 9574, 9575, 9576, 9577, 9578, 9579, 9580, 9581, 9582, 9583, 9584, 9585, 9586, 9587, 9588, 9589, 9590, 9591, 9592, 9593, 9594, 9595, 9596, 9597, 9598, 9599, 9600, 9601, 9602, 9603, 9604, 9605, 9606, 9607, 9608, 9609, 9610, 9611, 9612, 9613, 9614, 9615, 9616, 9617, 9618, 9619, 9620, 9621, 9622, 9623, 9624, 9625, 9626, 9627, 9628, 9629, 9630, 9631, 9632, 9633, 9634, 9635, 9636, 9637, 9638, 9639, 9640, 9641, 9642, 9643, 9644, 9645, 9646, 9647, 9648, 9649, 9650, 9651, 9652, 9653, 9654, 9655, 9656, 9657, 9658, 9659, 9660, 9661, 9662, 9663, 9664, 9665, 9666, 9667, 9668, 9669, 9670.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1899-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1893-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-06-02
Z-1894-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-06-02
Z-1895-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-06-02
Z-1896-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-06-02
Z-1897-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-06-02
Z-1898-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-06-02
Z-1899-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-06-02
Z-1900-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-06-02

Product code GEI

K914910Class IIDavol Laparoscopic Instruments (Gen Surg Reusable)Davol, Inc. / cleared 1992-01-06

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)