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Aesculap Implant Systems LLC
Aesculap Implant Systems LLC: 61 FDA recall reports
Every medical device recall the FDA has published for Aesculap Implant Systems LLC. The fault, and how the agency graded it.
61Reports
0Class I
5Ongoing
2023-09-13Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Z-2518-2023 · Class II · reported 2023-09-13 · Ongoing
- Why it was recalled
- Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured.
- Product
- For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
- Where it went
- US Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX.
- How much
- 25 units
Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Num
Z-2146-2023 · Class II · reported 2023-07-26 · Ongoing
- Why it was recalled
- Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.
- Product
- Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
- Where it went
- US Nationwide distribution in the states of DC, MO, PA, TX.
- How much
- 7 units
Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagula
Z-1569-2023 · Class II · reported 2023-05-17 · Ongoing
- Why it was recalled
- 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.
- 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
- Where it went
- US Nationwide distribution in the state of OH.
- How much
- 6 pieces
Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full
Z-1430-2023 · Class II · reported 2023-05-03 · Ongoing
- Why it was recalled
- Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.
- Product
- Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments. Note: The CCR basket lid is also distributed with ME764 CCR Basket - Full System
- Where it went
- US Nationwide distribution in the states of CA, OH, NE, NH, FL, PA, TX.
- How much
- ME754: 3 units; ME764: 22 units
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilizatio
Z-1638-2022 · Class II · reported 2022-09-07 · Ongoing
- Why it was recalled
- Potential for the incorrect screw to be included in the package.
- Product
- Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014
- Where it went
- GA, TX
- How much
- 6 units
Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
Z-1516-2022 · Class II · reported 2022-08-17 · Terminated
- Why it was recalled
- Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:
- Product
- Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
- Where it went
- US Distribution to states of: AR, IN, NE and NC
- How much
- 5 units
PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Z-1482-2022 · Class II · reported 2022-08-10 · Completed
- Why it was recalled
- Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
- Product
- PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
- Where it went
- United States Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Washington DC and Puerto Rico.
- How much
- 399
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Z-1481-2022 · Class II · reported 2022-08-10 · Completed
- Why it was recalled
- Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
- Product
- PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
- Where it went
- United States Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Washington DC and Puerto Rico.
- How much
- 3392
AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in sp
Z-1444-2022 · Class II · reported 2022-07-27 · Terminated
- Why it was recalled
- Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
- Product
- AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery.
- Where it went
- United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.
- How much
- 24
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument u
Z-1391-2022 · Class II · reported 2022-07-27 · Completed
- Why it was recalled
- Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
- Product
- ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
- Where it went
- US Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA, MO, NC, OK, TX, WI.
- How much
- 67
MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Z-1410-2022 · Class II · reported 2022-07-27 · Terminated
- Why it was recalled
- Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.
- Product
- MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
- Where it went
- US: CA, FL, GA, IL, OH & MI
- How much
- 9 pieces
AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Us
Z-1448-2022 · Class II · reported 2022-07-27 · Terminated
- Why it was recalled
- Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
- Product
- AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spinal fusion surgery.
- Where it went
- United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.
- How much
- 27
RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
Z-1405-2022 · Class II · reported 2022-07-27 · Terminated
- Why it was recalled
- Customized coronal rod benders may deform the implant when used with the spinal system devices.
- Product
- RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
- Where it went
- United States: CO
- How much
- 2 pieces
AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Us
Z-1447-2022 · Class II · reported 2022-07-27 · Terminated
- Why it was recalled
- Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
- Product
- AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spinal fusion surgery.
- Where it went
- United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.
- How much
- 20
AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal
Z-1446-2022 · Class II · reported 2022-07-27 · Terminated
- Why it was recalled
- Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
- Product
- AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery.
- Where it went
- United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.
- How much
- 23
Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
Z-1409-2022 · Class II · reported 2022-07-27 · Completed
- Why it was recalled
- Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system.
- Product
- Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
- Where it went
- United States: NE
- How much
- 1
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Z-1428-2022 · Class II · reported 2022-07-27 · Terminated
- Why it was recalled
- Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system.
- Product
- ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
- Where it went
- United States Nationwide distribution in the states of CA, CO, IL, MI, OH & TX.
- How much
- 16
LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
Z-1406-2022 · Class II · reported 2022-07-27 · Terminated
- Why it was recalled
- Customized coronal rod benders may deform the implant when used with the spinal system devices.
- Product
- LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
- Where it went
- United States: CO
- How much
- 2 pieces
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Z-1429-2022 · Class II · reported 2022-07-27 · Terminated
- Why it was recalled
- Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system. Redesign of removal key.
- Product
- ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
- Where it went
- United States Nationwide distribution in the states of CA, CO, MI, NH, OH, SC & TX.
- How much
- 17
AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spin
Z-1443-2022 · Class II · reported 2022-07-27 · Terminated
- Why it was recalled
- Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
- Product
- AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery.
- Where it went
- United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.
- How much
- 24
AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spi
Z-1445-2022 · Class II · reported 2022-07-27 · Terminated
- Why it was recalled
- Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
- Product
- AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spinal fusion surgery.
- Where it went
- United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.
- How much
- 24
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping u
Z-1449-2022 · Class II · reported 2022-07-27 · Terminated
- Why it was recalled
- Packaging seal integrity not validated resulting in a lack of sterility assurance.
- Product
- Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
- Where it went
- United States: CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA and WI
- How much
- 4500 pieces
AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to g
Z-1383-2022 · Class II · reported 2022-07-20 · Terminated
- Why it was recalled
- Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
- Product
- AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
- Where it went
- United States: TX and AK
- How much
- 7 pieces
PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
Z-2578-2021 · Class II · reported 2021-10-06 · Terminated
- Why it was recalled
- Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
- Product
- PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
- Where it went
- US Nationwide distribution in the states of FL, MI, NY, TX, WI.
- How much
- 80 units
PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
Z-2579-2021 · Class II · reported 2021-10-06 · Terminated
- Why it was recalled
- Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
- Product
- PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
- Where it went
- US Nationwide distribution in the states of FL, MI, NY, TX, WI.
- How much
- 350 units
Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/
Z-2509-2021 · Class II · reported 2021-09-29 · Terminated
- Why it was recalled
- Malfunction- loosening of the implant resulting in a potential revision surgery
- Product
- Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; NL471 UNIVATION F MENISCAL COMP.T2 RM/LM 7MM; NL472 UNIVATION F MENISCAL COMP.T3 RM/LM 7MM NL473 UNIVATION F MENISCAL COMP.T4 RM/LM 7MM NL474 UNIVATION F MENISCAL COMP.T5 RM/LM 7MM NL475 UNIVATION F MENISCAL COMP.T6 RM/LM 7MM
- Where it went
- US Nationwide distribution.
Univation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBIA CEMENTED
Z-2514-2021 · Class II · reported 2021-09-29 · Terminated
- Why it was recalled
- Malfunction- loosening of the implant resulting in a potential revision surgery
- Product
- Univation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBIA CEMENTED T1 RM; NO157Z AS UNIVATION XF TIBIA CEMENTED T2 RM; NO158Z AS UNIVATION XF TIBIA CEMENTED T3 RM; NO159Z AS UNIVATION XF TIBIA CEMENTED T4 RM; NO160Z AS UNIVATION XF TIBIA CEMENTED T5 RM; NO161Z AS UNIVATION XF TIBIA CEMENTED T6 RM; NO162Z AS UNIVATION XF TIBIA CEMENTED T1 LM; NO163Z AS UNIVATION XF TIBIA CEMENTED T2 LM; NO164Z AS UNIVATION XF TIBIA CEMENTED T3 LM; NO165Z AS UNIVATION XF TIBIA CEMENTED T4 LM; NO166Z AS UNIVATION XF TIBIA CEMENTED T5 LM; NO167Z AS UNIVATION XF TIBIA CEMENTED T6 LM;
- Where it went
- US Nationwide distribution.
Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/
Z-2513-2021 · Class II · reported 2021-09-29 · Terminated
- Why it was recalled
- Malfunction- loosening of the implant resulting in a potential revision surgery
- Product
- Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM; NL495 UNIVATION F MENISCAL COMP.T2 RM/LM 11MM; NL496 UNIVATION F MENISCAL COMP.T3 RM/LM 11MM NL497 UNIVATION F MENISCAL COMP.T4 RM/LM 11MM NL498 UNIVATION F MENISCAL COMP.T5 RM/LM 11MM NL499 UNIVATION F MENISCAL COMP.T6 RM/LM 11MM
- Where it went
- US Nationwide distribution.
Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED
Z-2515-2021 · Class II · reported 2021-09-29 · Terminated
- Why it was recalled
- Malfunction- loosening of the implant resulting in a potential revision surgery
- Product
- Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; NO181Z AS UNIVATION XF FEMUR CEMENTED F2 RM; NO182Z AS UNIVATION XF FEMUR CEMENTED F3 RM; NO183Z AS UNIVATION XF FEMUR CEMENTED F4 RM; NO184Z AS UNIVATION XF FEMUR CEMENTED F5 RM; NO185Z AS UNIVATION XF FEMUR CEMENTED F1 LM; NO186Z AS UNIVATION XF FEMUR CEMENTED F2 LM; NO187Z AS UNIVATION XF FEMUR CEMENTED F3 LM; NO188Z AS UNIVATION XF FEMUR CEMENTED F4 LM; NO189Z AS UNIVATION XF FEMUR CEMENTED F5 LM
- Where it went
- US Nationwide distribution.
Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/
Z-2510-2021 · Class II · reported 2021-09-29 · Terminated
- Why it was recalled
- Malfunction- loosening of the implant resulting in a potential revision surgery
- Product
- Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM; NL477 UNIVATION F MENISCAL COMP.T2 RM/LM 8MM; NL478 UNIVATION F MENISCAL COMP.T3 RM/LM 8MM; NL479 UNIVATION F MENISCAL COMP.T4 RM/LM 8MM; NL480 UNIVATION F MENISCAL COMP.T5 RM/LM 8MM; NL481 UNIVATION F MENISCAL COMP.T6 RM/LM 8MM
- Where it went
- US Nationwide distribution.
Showing the 30 most recent of 61. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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