The Recall Desk

Manufacturer

Aesculap, Inc.

40 recalls in our database name Aesculap, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
40
Critical
0
Severe
5
Most recent
2026-03-11

Of the 40 recalls from Aesculap, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (13%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–40 of 40

  • ModerateFDA (Devices)·Z-1012-2015·2015-02-04

    Aesculap Miethke Shunt System Accessories Recalled for Incorrect MR Safety Labeling

    Aesculap, Inc. is recalling Miethke Shunt System accessories because the shelf box labels incorrectly display an MR conditional symbol. The product is actually MR unsafe, and the correct information is only provided in the Instructions for Use.

    Product
    Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0814-2015·2014-12-24

    Aesculap Miethke Shunt System Recalled for Missing Patient Labels

    Aesculap Inc. is recalling four units of the Miethke Shunt System miniNAV Valve due to missing patient labels. No patient injuries have been reported.

    Product
    Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0502-2015·2014-12-10

    Aesculap Dual Switch Valve Recalled for Incorrect Expiration Date Labeling

    Aesculap, Inc. is recalling three Dual Switch Valves due to incorrect expiration dates on inner sterile bag labels. No patient injuries have been reported.

    Product
    The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2024-2014·2014-07-16

    Aesculap Recalls Non-Sterile Sutures With Conflicting Sterile Labeling

    Aesculap is recalling 11 units of non-sterile Dafilon sutures because an additional label incorrectly states the product is sterile.

    Product
    Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding 12 sutures
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1676-2014·2014-06-11

    Aesculap Miethke Ventricular Catheter Recalled Due to Deflector Movement Issues

    Aesculap, Inc. is recalling 48 units of the Miethke Ventricular Catheter with Deflector because the deflector did not move freely in three reported cases.

    Product
    Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0989-2014·2014-02-26

    Aesculap proSA Adjustment Disc Recalled for Accuracy Out of Specification

    Aesculap, Inc. is recalling 79 units of the proSA Adjustment Disc Size Large because the accuracy is out of specification.

    Product
    Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0623-2014·2014-01-15

    Aesculap Recalls Hi-Line XXS Handpieces Due to Possible Failure

    Aesculap, Inc. is recalling 14 Hi-Line XXS handpieces due to a possible failure of the device. The handpieces are used to hold burrs that cut and shape bone.

    Product
    Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the HiLAN¿ and microspeed motor systems to hold burrs which cut and shape bone.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0492-2014·2013-12-25

    Aesculap Columbus Revision CoCr Spacers Recalled Due to Incompatibility

    Aesculap, Inc. is recalling 24 Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7, because they were not compatible.

    Product
    Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0479-2014·2013-12-18

    Aesculap GNI161 Bipolar Foot Control Recalled for Energy Failure

    Aesculap, Inc. is recalling 85 GNI161 Bipolar Foot Controls because the bipolar energy did not stop after the foot control was released.

    Product
    Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0361-2014·2013-11-27

    Aesculap Arcadius XP L Trial Insertion Instrument Recall for Weak Weld

    Aesculap is recalling 30 Arcadius XP L Trial Insertion Instruments because a weak weld may cause the device to disassemble during use.

    Product
    Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0031-2014·2013-10-30

    Aesculap Recalls UNITRAC Pneumatic Retraction Arms Due to Safety Instructions

    Aesculap, Inc. is recalling 217 UNITRAC Pneumatic Retraction Arms because updated instructions for use are required to ensure safe operation and extend product life.

    Product
    UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1806-2013·2013-07-31

    Aesculap ProSpace PEEK Spinal Implant Recalled for Incorrect Etching

    Aesculap is recalling nine ProSpace PEEK spinal implants because they are incorrectly etched with an 8-degree lordosis instead of the labeled 5-degree lordosis.

    Product
    ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0887-2013·2013-03-06

    Aesculap Bipolar Generator Foot Pedal Recalled for Energy Failure

    Aesculap, Inc. is recalling 59 Bipolar Generator Foot Pedals because the bipolar energy did not stop after the pedal was released.

    Product
    Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0805-2013·2013-02-20

    Aesculap Miethke Shunt System Recalled Due to Deflector Movement Issue

    Aesculap, Inc. is recalling 11 units of the Miethke Shunt System because the deflector may not move freely on the ventricular catheter.

    Product
    Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide Central Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0082-2013·2012-10-24

    Aesculap Recalls Two Columbus Femoral Cutting Guides Due to Marking Error

    Aesculap, Inc. is recalling two Columbus 4-IN-1 Femoral Cutting Guide Instruments because the laser markings for size identification are incorrect, although the instruments are correctly dimensioned.

    Product
    Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
    Category
    Medical Device
    Distribution
    2 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Aesculap

German surgical instrument company

Country
Germany
Founded
1867

Official website

Source: Wikidata (Q44092), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.