Aesculap Implant Systems LLC recalls
Every recall we track for Aesculap Implant Systems LLC — 51 in all, from 2017–2023 — plus the complaints and injury reports the public filed about them. 2 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Aesculap Implant Systems LLC peaked in 2020 (15); 51 since 2017. 4% rated “stop using now”.
All FDA recall records for Aesculap Implant Systems LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 4 | 3 | 7 |
| 2018 | 0 | 0 | 4 | 0 | 4 |
| 2019 | 0 | 0 | 4 | 1 | 5 |
| 2020 | 1 | 8 | 6 | 0 | 15 |
| 2021 | 0 | 10 | 4 | 0 | 14 |
| 2022 | 0 | 0 | 2 | 0 | 2 |
| 2023 | 1 | 1 | 2 | 0 | 4 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for Aesculap Implant Systems LLC recalls
What to do if you have a recalled Aesculap Implant Systems LLC product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Aesculap Implant Systems LLC recalls
27 shown- Use cautionMedical device
Aesculap Implant Systems LLC recalls For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Aesculap recalls specific brain ventricle implant systems (product code FF399R) due to trocar shaft length issues that may obscure the visual field when used with certain neuroendoscopes.
AesculapJul 20, 2023 - Lower riskMedical device
Aesculap Implant Systems LLC recalls Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
Aesculap recalls surgical needles with incorrect product code MD611 instead of MD610. This may cause confusion in medical use. Affected needles have specific model numbers and lot details.
AesculapMay 18, 2023 - Stop using nowMedical device
Aesculap Implant Systems LLC recalls Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for
Aesculap recalls its Caiman Articulating D5/360MM surgical device due to risk of spring falling out during procedures, potentially entering the patient's body. Affected units have specific product codes and lot numbers.
AesculapMar 21, 2023 - Lower riskMedical device
Aesculap Implant Systems LLC recalls Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System -
Aesculap recalls Caspar Cervical Retractor Basket ME754 and ME764 due to mislabeled GTIN numbers. This affects medical devices used in surgeries. No immediate action needed as the product is safe but must be identified correctly.
AesculapFeb 23, 2023 - Lower riskMedical device
Aesculap Implant Systems LLC recalls Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the
Aesculap recalls ENNOVATE sterile set screws for spinal stabilization due to potential incorrect screw inclusion in packages. Affected units include specific lot numbers and article codes.
AesculapJul 15, 2022 - Lower riskMedical device
Aesculap Implant Systems LLC recalls Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
Aesculap recalls robotic microscopes with software 2.7 or earlier due to application errors causing rebalancing, robot recovery, and autofocus issues. Affected units have specific serial numbers and article numbers.
Aescul: Aesculap Implant Systems LLCJul 14, 2022 - Use cautionMedical device
Aesculap Implant Systems LLC recalls MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Aesculap recalls Modulift VBR SZ.M 4MM set screwdriver (MF790R) due to risk of deforming during surgery. Affected units have UDI-DI: 04046964067648. Contact for remedy.
Aescul: Aesculap Implant Systems LLCOct 25, 2021 - Use cautionMedical device
Aesculap Implant Systems LLC recalls RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
Aesculap recalls specific spinal surgery instrument (TEK1940) due to risk of implant deformation during spinal procedures. Affected units sold with lot number 2930902A.
Aescul: Aesculap Implant Systems LLCJun 30, 2021 - Use cautionMedical device
Aesculap Implant Systems LLC recalls PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
Aesculap recalls PAS-PORT Proximal Anastomosis System (FC700SU) due to potential deployment failure requiring additional surgery. Affected units include all batch codes.
Aescul: Aesculap Implant Systems LLCApr 16, 2021 - Lower riskMedical device
Aesculap Implant Systems LLC recalls Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM;
Aesculap recalls specific Univation X System knee implants due to possible loosening requiring revision surgery. Affected models include NL470 to NL475 with all lots.
AesculapMar 19, 2021 - Use cautionMedical device
Aesculap Implant Systems LLC recalls Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
Aesculap recalls Universal Robot UR5 arm (PV010204) for potential robotic arm malfunction causing system restarts. Affected units have specific UDI-DI and serial numbers.
AesculapFeb 19, 2021 - Use cautionMedical device
Aesculap Implant Systems LLC recalls ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Aesculap recalls ENNOVATE MIS REMOVALKEY SHORT (product code SZ380R) after risk of spinal fixation arm fracture during spinal surgery procedures.
Aescul: Aesculap Implant Systems LLCNov 18, 2020 - Use cautionMedical device
Aesculap Implant Systems LLC recalls AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion
Aesculap recalls S4 Cervical Cross Connectors (SWT113T) used in spinal fusion due to potential movement or microparticle abrasion. Affected patients should contact manufacturer for details.
Aescul: Aesculap Implant Systems LLCSep 8, 2020 - Use cautionMedical device
Aesculap Implant Systems LLC recalls ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Aesculap recalls ENNOVATE MIS Removal Key Short (SZ380R) due to risk of spinal fixation arm fracture if 90-degree angle not met during use. Affected users should contact for details.
Aescul: Aesculap Implant Systems LLCJul 13, 2020 - Stop using nowMedical device
Aesculap Implant Systems LLC recalls PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Aesculap recalls Prestige Retraction Graspers with potential handle separation. Affected models include 8361-10 (UDI-DI: 04046955083381) sold in specific lots. Stop using immediately to avoid injury.
AesculapApr 1, 2020 - Lower riskMedical device
Aesculap Implant Systems LLC recalls Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K
Aesculap Implant Systems LLC
AesculapJan 21, 2020 - Lower riskMedical device
Aesculap Implant Systems LLC recalls ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during
Aesculap recalls Enduro Special Key Tib Lock Ring F1/10mm (product code NP462R) used in knee surgery due to potential key pin damage during assembly. Affected items sold with EnduRo Total Knee System.
AesculapNov 12, 2019 - Lower riskMedical device
Aesculap Implant Systems LLC recalls Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit,
Aesculap recalls sterile disposable fleece drapes (product code GA414) due to unverified packaging seals risking contamination. Affected units include specific lot numbers and shipping units.
AesculapOct 1, 2019 - Lower riskMedical device
Aesculap Implant Systems LLC recalls AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a
Aesculap recalls a surgical needle holder labeled as 200mm but actually 150mm. This size error may cause improper use during procedures. Affected units have product code MG524R.
Aescul: Aesculap Implant Systems LLCSep 25, 2019 - Lower riskMedical device
Aesculap Implant Systems LLC recalls CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and
Aesculap recalls specific surgical instruments due to potential insufficient sterilization in certain batches. Affected instruments may pose infection risks during procedures.
Aescul: Aesculap Implant Systems LLCAug 7, 2019 - Lower riskMedical device
Aesculap Implant Systems LLC recalls Strauss Penis Clamp 130MM/General Instruments
Aesculap recalls Strauss Penis Clamp 130MM/General Instruments due to plastic sleeves sticking during reprocessing, making instruments unusable after reprocessing. Affected units include model EF401R.
Aescul: Aesculap Implant Systems LLCFeb 16, 2018 - Lower riskMedical device
Aesculap Implant Systems LLC recalls DS Titanium Ligation Clip, used in laparoscopic surgery
Aesculap recalls DS Titanium Ligation Clips used in laparoscopic surgery for living donor kidney transplants. The clips were not approved for this use per 2017 publication.
AesculapJan 22, 2018 - UnratedMedical device
Aesculap Implant Systems LLC recalls proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
Aesculap recalls proSA Tool Sets (batch #20034364, #20034751) that may not set correct valve pressure in shunt systems, risking improper treatment.
Aescul: Aesculap Implant Systems LLCSep 21, 2017 - UnratedMedical device
Aesculap Implant Systems LLC recalls JS Series SterilContainer S2 System
Aesculap recalls JS Series SterilContainer S2 Systems sold without FDA 510K clearance. These surgical containers may pose risks due to lack of regulatory approval before market release.
AesculapSep 8, 2017 - Lower riskMedical device
Aesculap Implant Systems LLC recalls ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0
Aesculap recalls ELAN 4 blade accessories sold without required 510(k) clearance. These surgical tools may not meet safety standards. Consumers should contact Aesculap for details.
AesculapSep 5, 2017 - UnratedMedical device
Aesculap Implant Systems LLC recalls The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro,
Aesculap recalls ELAN 4 Air System devices for spine, ENT, neuro and maxillofacial surgery that were sold without FDA clearance. This unapproved device may pose risks during surgical procedures.
AesculapSep 1, 2017 - Lower riskMedical device
Aesculap Implant Systems LLC recalls NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected
Aesculap recalls Vega Knee System component NS357R size T4 due to possible incorrect labeling. Using the wrong size may cause ligament injury, pain, or revision surgery.
AesculapAug 10, 2017
Aesculap Implant Systems LLC recall questions
How many recalls has Aesculap Implant Systems LLC had?
51 recalls from Aesculap Implant Systems LLC are on record with U.S. safety agencies, from 2017–2023.
What is the most recent Aesculap Implant Systems LLC recall?
Aesculap Implant Systems LLC recalls For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R, dated Jul 20, 2023. Every Aesculap Implant Systems LLC recall is listed on this page, newest first.
Why are Aesculap Implant Systems LLC products recalled?
The most common reasons on record: Malfunction- loosening of the implant resulting in a potential revision surgery (8); possibility of the sterility batch being insufficiently sterilized (2).
What should I do if I have a recalled Aesculap Implant Systems LLC product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Aesculap Implant Systems LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.