Recall archive
25 recalls · page 1 of 2
Reported Sep 13, 2023
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
Matched: Brand — Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a…
FDA (openFDA device enforcement)
Reported Jul 26, 2023
Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
Matched: Brand · Product · Product details — Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.
FDA (openFDA device enforcement)
Reported May 17, 2023
Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
Matched: Brand · Product · Product details — 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…
FDA (openFDA device enforcement)
Reported May 3, 2023
Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
Matched: Brand · Product · Product details — Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.
FDA (openFDA device enforcement)
Reported Sep 7, 2022
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
Matched: Brand · Product · Product details — Potential for the incorrect screw to be included in the package.
FDA (openFDA device enforcement)
Reported Aug 17, 2022
Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
Matched: Brand — Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:
FDA (openFDA device enforcement)
Reported Aug 10, 2022
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
Matched: Brand — Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 27, 2022
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
Matched: Brand · Product · Product details — Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
13 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 20, 2022
AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
Matched: Brand · Product · Product details — Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
FDA (openFDA device enforcement)
Reported Oct 6, 2021
PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
Matched: Brand · Product · Product details · Reason for recall — Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 29, 2021
Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
Matched: Brand · Product · Product details · Reason for recall — Malfunction- loosening of the implant resulting in a potential revision surgery
7 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 25, 2020
Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
Matched: Brand · Product · Product details · Reason for recall — Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2019
CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
Matched: Brand — possibility of the sterility batch being insufficiently sterilized
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 18, 2018
Doyen-Collin Mouth Gag 120MM/ General Instruments
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Aesculap Implant Systems LLC
Matched: Brand — The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 11, 2018
DS Titanium Ligation Clip, used in laparoscopic surgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
Matched: Brand · Reason for recall — Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. A publication from 2017…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 7, 2018
proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
Matched: Brand · Product · Product details · Reason for recall — A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
FDA (openFDA device enforcement)
Reported Feb 21, 2018
NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
Matched: Brand · Product · Product details · Reason for recall — The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the incorrect size trial is used the potential risk is…
5 more products in this recall
FDA (openFDA device enforcement)
Reported May 24, 2017
GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; GP163R; ELAN 4 1-RING…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
Matched: Brand · Product details — Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 19, 2017
AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
Matched: Brand · Product · Product details · Reason for recall — Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sharp edges on the distal end which may lead to the…
FDA (openFDA device enforcement)
Reported Feb 22, 2017
GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
Matched: Brand — Generators may have a faulty component which could impact the proper functioning of the device.
FDA (openFDA device enforcement)
Reported Jan 11, 2017
Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
Matched: Brand · Reason for recall — Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps.
FDA (openFDA device enforcement)
Reported Nov 2, 2016
Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
Matched: Brand — There is a potential for the needle to detach from the suture thread during surgery. If the needle becomes detached the defective suture will need to…
FDA (openFDA device enforcement)
Reported Sep 19, 2012
Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
Matched: Brand · Product · Product details — There is a possibility that the screw channel that holds the rod in place may be out of tolerance. When the depth of the channel is not deep enough,…
FDA (openFDA device enforcement)
Reported Aug 8, 2012
Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aesculap Implant Systems LLC
Matched: Brand · Product · Product details — The 4 degree and 9 degree trial instruments (SJ768T-US/SJ780T-US) are correctly dimensioned, but the part number etched on the instrument may be…
FDA (openFDA device enforcement)
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