Aesculap, Inc.: 40 FDA recall reports
Every medical device recall the FDA has published for Aesculap, Inc.. The fault, and how the agency graded it.
40Reports
0Class I
18Ongoing
2026-03-11Most 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.
Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Sof
Z-1485-2026 · Class II · reported 2026-03-11 · Ongoing
- Why it was recalled
- There is the potential for the length of the trocar shaft to be too long.
- Product
- Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Description: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Component: N/A
- Where it went
- US Nationwide distribution in the states of AZ, AR, CA, CO, FL, GA, HI, IA, ID, IL, KS, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TX, UT, WA.
- How much
- 126 units
Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P So
Z-0309-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
- Product
- Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Description: SEALING UNIT F/10/12MM TROCARS W.REDUCER Component: N/A
- Where it went
- Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, MD, NE, NM, NY, OR, PA, WA, WI and the country of Canada.
- How much
- 26 units
Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software
Z-0312-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
- Product
- Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description: REDUCING CONVERTER 10/12MM TO 5MM Component: N/A
- Where it went
- Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, MD, NE, NM, NY, OR, PA, WA, WI and the country of Canada.
- How much
- 155 units
Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Ve
Z-0310-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
- Product
- Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description: SEALING CAP FOR 10/12MM TROCARS Component: N/A
- Where it went
- Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, MD, NE, NM, NY, OR, PA, WA, WI and the country of Canada.
- How much
- 140 units
Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software V
Z-0311-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
- Product
- Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description: SEALING UNIT FOR 10/12MM TROCARS Component: N/A
- Where it went
- Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, MD, NE, NM, NY, OR, PA, WA, WI and the country of Canada.
- How much
- 26 units
Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2)
Z-1312-2025 · Class II · reported 2025-03-19 · Ongoing
- Why it was recalled
- The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
- Product
- Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952R, Negus Tonsil Forceps X-HVY-CVD190MM; (3) REF BH957R, Schnidt Tonsil Forceps SLT-CVD185MM; (4) REF BH959R, Schnidt Tonsil Forceps CVD 185MM; (5) REF BH961R, Schnidt Tonsil FCPSOPEN-RINGCVD 185MM; (6) REF BH963R, Schnidt Tonsil FCPSOPEN-RINGCVD185MM; and (7) REF BH965R, Wilson Tonsil Forceps 190MM.
- Where it went
- Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.
- How much
- 47,078 forceps
Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM;
Z-1308-2025 · Class II · reported 2025-03-19 · Ongoing
- Why it was recalled
- The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
- Product
- Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJ501R, Phaneuf Hysterectomy Forceps ANG 205MM; (3) REF BJ511R, Holzbach Hyst Forceps CVD245MM; (4) REF BJ520R, Heaney Hyst Forceps Grooved 205MM; (5) REF BJ521R, Heaney Hyst Forceps Grooved 250MM; (6) REF BJ522R, Heaney Hyst Forceps Grooved 195MM; (7) REF BJ524R, Heaney-Rezek Fcpsstr Ser Lgth 210MM; (8) REF BJ527R, Wiener Hyst Forceps Grooves 240MM; (9) REF BJ530R, Heaney Hysterectomy Forceps STR 225MM; (10) REF BJ531R, Heaney Hysterectomy Forceps CVD200MM; (11) REF BJ532R, Heaney Hysterectomy Forceps CVD215MM; (12) REF BJ534R, Hysterectomy For.Gwilliamsstr.205MM; (13) REF BJ550R, Wertheim Parametrium Clamp STR 250MM; (14) REF BJ551R, Wertheim Parametrium Clamp CVD245MM; (15) REF BJ552R, Wertheim Parametrium Clamp CVD240MM; (16) REF BJ553R, Wertheim Parametrium Clamphvy-CVD220MM; (17) REF MD591, Heany Ballentine Hyst Fcps STR.215MM; and (18) REF MD592, Heany Ballentine Hyst Fcps CVD.215MM.
- Where it went
- Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.
- How much
- 19,979 forceps
Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps 85MM; (2) REF BH104R
Z-1309-2025 · Class II · reported 2025-03-19 · Ongoing
- Why it was recalled
- The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
- Product
- Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps 85MM; (2) REF BH104R, Hartmann Mosquito FCSDEL STR 100MM; (3) REF BH105R, Hartmann Mosquito FCPSDELCVD100MM; (4) REF BH108R, Micro-Halsted Forceps DEL STR125MM; (5) REF BH109R, Micro-Halsted Forceps DEL CVM 125mm; (6) REF BH114R, Hartmann Mosquito FCPSDELSTR1X2100MM; (7) REF BH115R, Hartmann Mosquito FCPSDELCVD1X2100MM; (8) REF BH118R, Micro-Halsted FCPS Del STR 1X2125MM; (9) REF BH119R, Micro-Halsted FCPS Del CVD 1X2125MM; (10) REF BH120R, Halsted-Mosquito FCPSDELSTR1X2125MM; (11) REF BH121R, Halsted-Mosquito FCPS DELCVD1X2125MM; (12) REF BH130R, Providence-Hosp FCPS Del STR140MM; (13) REF BH131R, Providence-Hosp FCPS Del CVD 140MM; (14) REF BH134R, Kelly Forceps Del STR 140MM; (15) REF BH135R, Kelly Forceps Del CVM 140MM; (16) REF BH139R, Dandy Delicate Forceps CVD140MM; (17) REF BH140R, Baby Crile Forceps Del STR 140MM; (18) REF BH141R, Baby Crile FORCEPSDELCVD140MM; (19) REF BH143R, Dandy Del FCPS LAT-CVD 1X2 140MM; (20) REF BH144R, Crile Forceps STR 140MM; (21) REF BH145R, Crile Forceps CVD 140MM; (22) REF BH150R, Baby Kocher Forceps STR 140MM; (23) REF BH151R,...
- Where it went
- Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.
- How much
- 917,965 forceps
Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD 215MM; (2) REF FB45
Z-1311-2025 · Class II · reported 2025-03-19 · Ongoing
- Why it was recalled
- The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
- Product
- Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD 215MM; (2) REF FB459R, Glover ATR.CLAMP CVD 245MM; (3) REF FB461R, Glover ATR.CLAMP 195MM; (4) REF FB462R, Glover ATR.CLAMP 210MM; (5) REF FB469R, Leland-Jones Peripheral CLMPSTR 195MM; (6) REF FB567R, Cooley Pediatric Clamp 30DG30/165MM; (7) REF FB568R, Cooley Pediatric Clamp 60DG 30/160MM; (8) REF FB569R, Cooley Pediatric Clamp 90DG30/150MM; (9) REF FB729R, Cooley Pediatric Clamp 17MM 170MM; (10) REF FB730R, Cooley Pediatric Clamp 20MM175MM; (11) REF FB736R, Cooley Pediatric Clamp 74MM 185MM; (12) REF FB737R, Cooley Pediatric Clamp 86MM 195MM; and (13) REF FB738R, Cooley Pediatric Clamp 108MM 260MM.
- Where it went
- Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.
- How much
- 1,147 forceps
Numerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig Artery Forceps CVD.190MM; (2) RE
Z-1310-2025 · Class II · reported 2025-03-19 · Ongoing
- Why it was recalled
- The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
- Product
- Numerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig Artery Forceps CVD.190MM; (2) REF BH304R, Pean Artery Forceps Straight 140MM; (3) REF BH813R, Artery Forceps Curved 250MM; (4) REF BJ016R, Diss.A.Ligat.Forceps S-Shaped CVD.210MM; (5) REF BJ020R, Overholt-Geiss Suture FCPS #0CVD195MM; (6) REF BJ021R, Overholt-Geiss Suture FCPS #1CVD205MM; (7) REF BJ022R, Overholt-Geiss Suture FCPS #2CVD220MM; (8) REF BJ023R, Overholt-Geiss Suture FCPS #3 CVD225MM; (9) REF BJ025R, Overholt-Geiss Suture FCPS #5CVD230MM; (10) REF BJ026R, Overholt-Geiss Suture FCPS #6 CVD225MM; (11) REF BJ031R, Overholt-Geiss Suture FCPS#1CVD260MM; (12) REF BJ034R, Overholt-Geiss Suture FCPS#4CVD270MM; (13) REF BJ035R, Overholt-Geiss Suture FCPS #5CVD280MM; (14) REF BJ037R, Forceps CVD Delicate 145MM; (15) REF BJ038R, Forceps CVD.Delicate 185MM; (16) REF BJ039R, Forceps CVD.Delicate 235MM; (17) REF BJ041R, Rumel Suture Forceps SLT-CVD 240MM; (18) REF BJ042R, Rumel Suture Forceps CVD 240MM; (19) REF BJ043R, Rumel Suture Forceps MED-CV 240MM; (20) REF BJ044R, Rumel Suture Forceps HVY-CV 240MM; (21) REF BJ045R, Rumel Suture Forceps RT-ANG# 5 240MM; (22) REF BJ047R, Zenker...
- Where it went
- Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.
- How much
- 93,714 forceps
Aeos Robotic Digital Microscope, Product Code: PV010
Z-2139-2024 · Class II · reported 2024-06-19 · Ongoing
- Why it was recalled
- Possibility of the robotic arm to drop more than 10cm from its original position after pressing the emergency stop button due to failure of the integrated safety mechanism.
- Product
- Aeos Robotic Digital Microscope, Product Code: PV010
- Where it went
- US Nationwide distribution in the states of AR, FL, IL, IN, KY, MI, NC, NE, OK, SD, TX.
- How much
- 19 units
DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.
Z-1244-2024 · Class II · reported 2024-03-13 · Ongoing
- Why it was recalled
- The sterile blister packaging may be damaged, and sterility may be compromised.
- Product
- DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.
- Where it went
- Worldwide - US Nationwide distribution in the states of KS, NJ and NY. The country of Canada.
- How much
- 18 pieces
DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.
Z-1245-2024 · Class II · reported 2024-03-13 · Ongoing
- Why it was recalled
- The sterile blister packaging may be damaged, and sterility may be compromised.
- Product
- DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.
- Where it went
- Worldwide - US Nationwide distribution in the states of KS, NJ and NY. The country of Canada.
- How much
- 6 pieces
DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.
Z-1246-2024 · Class II · reported 2024-03-13 · Ongoing
- Why it was recalled
- The sterile blister packaging may be damaged, and sterility may be compromised.
- Product
- DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.
- Where it went
- Worldwide - US Nationwide distribution in the states of KS, NJ and NY. The country of Canada.
- How much
- 6 pieces
DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.
Z-1243-2024 · Class II · reported 2024-03-13 · Ongoing
- Why it was recalled
- The sterile blister packaging may be damaged, and sterility may be compromised.
- Product
- DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.
- Where it went
- Worldwide - US Nationwide distribution in the states of KS, NJ and NY. The country of Canada.
- How much
- 12 pieces
DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures.
Z-1247-2024 · Class II · reported 2024-03-13 · Ongoing
- Why it was recalled
- The sterile blister packaging may be damaged, and sterility may be compromised.
- Product
- DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures.
- Where it went
- Worldwide - US Nationwide distribution in the states of KS, NJ and NY. The country of Canada.
- How much
- 6 pieces
MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
Z-0867-2024 · Class II · reported 2024-02-07 · Ongoing
- Why it was recalled
- Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.
- Product
- MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
- Where it went
- US Nationwide distribution in the states of CA, CO, FL, ID, KY, MD, MO, MT, NV, NY, OR, PA, RI, TN, TX, VA.
- How much
- 60
MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 22
Z-0866-2024 · Class II · reported 2024-02-07 · Ongoing
- Why it was recalled
- Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.
- Product
- MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";
- Where it went
- US Nationwide distribution in the states of CA, CO, FL, ID, KY, MD, MO, MT, NV, NY, OR, PA, RI, TN, TX, VA.
- How much
- 53
Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and End
Z-1043-2016 · Class II · reported 2016-03-09 · Terminated
- Why it was recalled
- Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem implant packaging that are used for Columbus Revision/Enduro Knee Implants because it is labeled as Cementless. US product is indicated in the US for use with Bone Cement only.
- Product
- Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint.
- Where it went
- US Nationwide Distribution
- How much
- 1232
Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retractor is used in heart surgery. Th
Z-0566-2016 · Class II · reported 2016-01-06 · Terminated
- Why it was recalled
- AAG received a customer complaint that corrosion had been found by a hospitals central sterile service department on the ball joint of an FC424R blade. Investigation revealed that the corrosion was due to incorrect material used in the manufacturing of the disk spring of the ball joint by the supplier
- Product
- Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retractor is used in heart surgery. The retractor is used for the temporary dilation of the left atrium in mitral valve surgery and for assistance in tricuspid valve surgery.
- Where it went
- US Distribution to state of: NY.
- How much
- 41
Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These instruments are i
Z-0422-2016 · Class II · reported 2015-12-30 · Terminated
- Why it was recalled
- The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
- Product
- Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
- Where it went
- Worldwide Distribution: US (nationwide) and country of: Canada.
- How much
- 37
Flexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG These instruments are intended fo
Z-0424-2016 · Class II · reported 2015-12-30 · Terminated
- Why it was recalled
- The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
- Product
- Flexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
- Where it went
- Worldwide Distribution: US (nationwide) and country of: Canada.
- How much
- 13
Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible
Z-0448-2016 · Class II · reported 2015-12-30 · Terminated
- Why it was recalled
- The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
- Product
- Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed. These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. Tray catalog number is: Tray designated as ST0485-037.
- Where it went
- Worldwide Distribution: US (nationwide) and country of: Canada.
- How much
- unknown
Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG: These instruments are intend
Z-0423-2016 · Class II · reported 2015-12-30 · Terminated
- Why it was recalled
- The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
- Product
- Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG: These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
- Where it went
- Worldwide Distribution: US (nationwide) and country of: Canada.
- How much
- 41
S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a de
Z-2326-2015 · Class II · reported 2015-08-12 · Terminated
- Why it was recalled
- A FW103R torque wrench that was improperly reassembled after reprocessing caused a screw to break during implantation due to too much torque. The firm did not include instructions for reassembly after reprocessing.
- Product
- S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined torque 2.8 Nm for tightening the clamping screw in the screw head/hook head/occipital plate/transverse connector and other connectors.
- Where it went
- Distributed US (nationwide) and to Canada.
- How much
- 10
Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospi
Z-1012-2015 · Class II · reported 2015-02-04 · Terminated
- Why it was recalled
- Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box label. The label should have NO symbol but instead is marked with the MR conditional symbol. The product is MR unsafe. This information is only required to be in the Instructions for Use (IFU).
- 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.
- Where it went
- Worldwide Distribution - US Nationwide
- How much
- 772
Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal flui
Z-0814-2015 · Class III · reported 2014-12-24 · Terminated
- Why it was recalled
- Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing patients' labels for the miniNAV (FV660T). There are no patient injuries resulting from this issue.
- 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.
- Where it went
- Distributed in OK, and WI.
- How much
- 4
The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocep
Z-0502-2015 · Class II · reported 2014-12-10 · Terminated
- Why it was recalled
- Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System, Dual Switch Valve, due to incorrect product labeling on three units. The incorrect product labeling was the wrong expiration date, 2024-09, on the inner labeling of the sterile bag. However, the expiration date on the outer box was correct. No patient injuries were reported as a result of this issue.
- Product
- The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
- Where it went
- US Distribution in Kansas only.
- How much
- 1
Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additio
Z-2024-2014 · Class II · reported 2014-07-16 · Terminated
- Why it was recalled
- Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4 non-sterile non-absorbable polyamide Surgical Suture due to a labeling issue. Box labels do state non-sterile; however there is an additional label that is affixed on the box that 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
- Where it went
- Distributed in the states of IL, NY, GA, and RI.
- How much
- 11
Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt Syst
Z-1676-2014 · Class II · reported 2014-06-11 · Terminated
- Why it was recalled
- AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.
- 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.
- Where it went
- US Distribution including the states of PA, KY, NY, RI, SC, KS, TX, CT, TN and WA.
- How much
- 48
Showing the 30 most recent of 40. 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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