Aesculap, Inc.
Aesculap, Inc. holds FDA 510(k) medical device clearances, first cleared 1991, most recent 2026, with 40 FDA device recalls on record.
Top product codes for Aesculap, Inc.
FDA recalls by Aesculap, Inc.
10 most recent of 40- Z-1485-2026 — 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
- Z-0309-2026 — 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
- Z-0310-2026 — 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
- Z-0312-2026 — 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
- Z-0311-2026 — 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
- Z-1308-2025 — 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.
- Z-1312-2025 — 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.
- Z-1309-2025 — 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, Kocher Forceps Del CVD 1X2140MM; (24) REF BH154R, Crile Forceps Del STR 1X2 140MM; (25) REF BH155R, Crile Forceps Del CVD 1X2 140MM; (26) REF BH160R, Leriche Delicate Forceps STR 150MM; (27) REF BH161R, Leriche Delicate Forceps CVD 150MM; (28) REF BH164R, Rankin FCPS Long Kelly Del STR160MM; (29) REF BH166R, Crile Forceps STR 160MM; (30) REF BH170R, Leriche Delicate Forceps STR 1X2150MM; (31) REF BH171R, Leriche Delicate Forceps CVD1X2150MM; (32) REF BH176R, Crile Forceps STR 1X2160MM; (33) REF BH177R, Crile Forceps CVD 1X2 160MM; (34) REF BH178R, Dixon-Lovelace Artery FCPS.1X2T.STR.160; (35) REF BH197R, Birkett Delicate Forceps CVD185MM; (36) REF BH199R, Nissen Delicate Forceps CVP 185MM; (37) REF BH200R, Adson Delicate Forceps STR185MM; (38) REF BH201R, Adson Delicate Forceps CVD 185MM; (39) REF BH202R, Halsted Delicate Forceps STR 185MM; (40) REF BH203R, Halsted Delicate Forceps CVD 185MM; (41) REF BH205R, Adson Hemostatic FCPS CVD.215MM; (42) REF BH206R, Heiss Delicate Forceps STR 200MM; (43) REF BH207R, Heiss Delicate Forceps CVD 200MM; (44) REF BH210R, Halsted-Mosquito Forceps DELSTR200MM; (45) REF BH211R, Halsted-Mosquito FCPS Del CVD 200MM; (46) REF BH212R, Halsted-Mosquito FCPSDELSTR1X2185MM; (47) REF BH213R, Halsted-Mosquito FCPSDELCVD1X2185MM; (48) REF BH214R, Halsted-Mosq.FCPSDELSTR1X2 200MM; (49) REF BH215R, Halsted-Mosq.FCPSDELCVD 1X2 200MM; (50) REF BH224R, Sarot Delicate Forceps 240MM; (51) REF BH225R, Crafoord Delicate Forceps CVD 245MM; (52) REF BH227R, Artery Forceps Crafoord MODIF.240MM; (53) REF BH228R, Bengolea Delicate Forceps STR 245MM; (54) REF BH229R, Bengolea Delicate Forceps CVD 245MM; (55) REF BH230R, Bridge Delicate Forceps STR 275MM; (56) REF BH231R, Bridge Delicate Forceps CVD 275MM; (57) REF BH234R, Sarot Delicate Forceps STR 1X2240MM; (58) REF BH316R, Pean Artery Forceps STR.165MM; (59) REF BH332R, Spencer-Wells Forceps STR130MM; (60) REF BH333R, Spencer-Wells Forceps CVD 130MM; continued
- Z-1311-2025 — 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.
- Z-1310-2025 — 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 Suture Forceps SLT-CVD 300MM; (23) REF BJ048R, Zenker Suture Forceps HVY-CVD 290MM; (24) REF BJ050R, Mixter-O'Shaugnessy Forceps CVD190MM; (25) REF BJ051R, Wikstroem Suture Forceps RT-ANG 205MM; (26) REF BJ052R, Finochietto Suture FCPCVDW/HOLE245MM; (27) REF BJ055R, Mixter Suture Forceps Rt-Ang 230MM; (28) REF BJ057R, Kantrowitz Thoracic Clamp 200MM; (29) REF BJ058R, Kantrowitz Thoracic Clamp 245MM; (30) REF BJ059R, Kantrowitz Thoracic Clamp 275MM; (31) REF BJ060R, Lahey Forceps Long-Serr 225MM; (32) REF BJ061R, Mixter Forceps Long-Serr220MM; (33) REF BJ062R, Mixter Forceps Long-Serr 250MM; (34) REF BJ068R, Lahey DISS.A.LIGAT.FORCEPS 230MM; (35) REF BJ070R, Lawrence Suture FCPS DEL CVDD 270MM; (36) REF BJ073R, Mixter Forceps Long-Serr 290MM; (37) REF BJ080R, Overholt Forceps # 0 CVD215MM; (38) REF BJ081R, Overholt Forceps # 1 CVD210MM; (39) REF BJ082R, Overholt Forceps # 2 CVD 220MM; (40) REF BJ083R, Overholt Forceps # 3 CVD 225MM; (41) REF BJ086R, Overholt Forceps # 6 CVD 225MM; (42) REF BJ090R, Overholt Forceps # 0 CVD 295MM; (43) REF BJ091R, Overholt Forceps # 1 CVD 295MM; (44) REF BJ096R, Overholt Forceps # 6 CVD 300MM; (45) REF BJ100R, Gemini Clamp RT-ANG140MM; (46) REF BJ102R, Gemini Clamp RT-ANG 180MM; (47) REF BJ103R, Gemini Clamp RT-ANG 200MM; (48) REF BJ104R, Gemini Clamp RT-ANG 230MM; (49) REF BJ106R, Gemini Clamp RT-ANG 280MM; (50) REF BJ120R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 160MM; (51) REF BJ121R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 180MM; (52) REF BJ122R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 200MM; (53) REF BJ123R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 220MM; (54) REF BJ130R, Zenker DISS & LIG FCPSSLT-CVD 350MM; (55) REF BJ131R, Zenker DISS & LIG FCPS CVD 350MM; continued
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Aesculap, Inc.
1–100 of 208- K260044 — Ventricular Catheters, Thomale Catheter
- K242762 — Aesculap Aicon® Series Container System
- K242003 — XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set
- K223596 — SQ.line KERRISON
- K214041 — Aesculap AICON Container
- K211572 — Aesculap Slim Clip Applier
- K203739 — ELAN 4 Electro Motor System
- K202391 — DIR 800
- K203461 — Aesculap Caiman 12 Seal and Cut Technology System
- K202938 — Aesculap Caiman 5 Seal and Cut Technology System
- K202124 — Aesculap PAS-Port Proximal Anastomosis System
- K200950 — Ventricular Catheter
- K192056 — JJ Series Container System
- K193582 — SterilContainer S2 System
- K192266 — M. Blue Adjustable Shunt System
- K183203 — ELAN 4 Tools
- K182414 — Aesculap® SterilContainer(TM) S2 System
- K190174 — Miethke Shunt System GAV 2.0 and SA 2.0 Valves
- K183180 — Caiman 5 Maryland
- K182527 — ELAN 4 Tools
- K182032 — SterilContainer S System
- K172907 — ELAN 4 Air Motor System
- K172709 — ELAN 4 Electro Motor System Tools
- K180914 — Aesculap Slim Clip Applier
- K180321 — Aesculap Optilene Nonabsorbable Suture
- K170683 — Aesculap Video Assisted Thoracic Surgery (VATS) INstruments
- K172850 — SterilContainer with PrimeLine Pro Lid
- K173271 — Aesculap Slim Clip Applier Forceps
- K171001 — Monosyn Quick Synthetic Absorbable Surgical Suture
- K162815 — SterilContainer S System
- K170661 — Novosyn Quick Absorbable Suture
- K161853 — proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System
- K152960 — ELAN 4 Motor System
- K160393 — AdTec
- K151165 — Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture
- K151865 — PremiPatch PTFE Pledget
- K151242 — SterilContainer S
- K143729 — SterilContainer S
- K151858 — Caiman Seal and Cut Technology
- K151696 — Caiman Seal and Cut Technology
- K142970 — SterilContainer S System
- K141687 — AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM
- K142315 — MINOP Disposable Introducer 26F
- K133890 — AESCULAP OPTILENE NONABSORBABLE SUTURE
- K140343 — AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP
- K140839 — CAIMAN SEAL AND CUT TECHNOLOGY
- K131500 — YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS
- K122791 — LYOPLANT ONLAY
- K121976 — AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE
- K130596 — CAIMAN SEAL AND CUT TECHNOLOGY
- K123102 — SOVEREIGN MINI
- K122734 — AESCULAP NOVOSYN ABSORBABLE SUTURE
- K122353 — CRAINFIX 2 TITANIUM CLAMP SYSTEM
- K120559 — AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM
- K111959 — AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE
- K110206 — AESCULAP- MEITHKE SHUNT SYSTEM
- K110695 — BIPOLAR HF DEVICE
- K103003 — AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM
- K091692 — AESCULAP PEEK CRANIOFIX
- K101937 — HYBRID TROCAR SYSTEM
- K102081 — ENDOSCOPIC CLIP SYSTEM
- K093493 — AESCULAP STERILCONTAINER S
- K100876 — AESCULAP MONOMAX ABSORBABLE SUTURE
- K081031 — ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE
- K073168 — AESCULAP PRIMELINE CONTAINER LTD.
- K080753 — AESCULAP ENDOSCOPIC CLIP SYTEM
- K062327 — MODIFICATION TO S4 SPINAL SYSTEM
- K062012 — S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM
- K062009 — AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T
- K063017 — AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM
- K062684 — EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD
- K062413 — AESCULAP PNEUMATIC KERRISON
- K062406 — AESCULAP NEURO PATTIES
- K060762 — AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
- K061699 — EXCIA
- K061344 — EXCIA TOTAL HIP SYSTEM LATERAL OFFSET
- K061424 — CELSITE/ CELSITE CONCEPT, ACCESS PORTS
- K061704 — OPTILENE MESH
- K060707 — AESCULAP BIPOLAR ACETABULAR CUP
- K060918 — EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD
- K053579 — COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE
- K060492 — AESCULAP CRANIOFACIAL PLATE AND SCREW
- K060528 — AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE
- K060437 — EXCIA TOTAL HIP SYSTEM WITH U-CAP
- K053389 — AESCULAP STERILCONTAINER SYSTEM
- K053390 — COLUMBUS (CR) TOTAL KNEE SYSTEM
- K060152 — MODIFICATION TO S4 SPINAL SYSTEM
- K053158 — OPTILENE MESH LP
- K053526 — MICROSPEED UNI MOTOR SYSTEM
- K050979 — S4 SPINAL SYSTEM
- K050813 — ABC 2 SCREW
- K050752 — AESCULAP ORTHOPILOT 2 THA V 2.0
- K050804 — MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM
- K042344 — EXCIA TOTAL HIP SYSTEM
- K041623 — REUSABLE STERILCONTAINER FILTER MODEL #JK090
- K043041 — AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX)
- K040017 — ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE)
- K040080 — AESCULAP ABSORBABLE CRANIOFIX
- K032108 — SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)
- K030367 — COLUMBUS (PS)
Data sourced from openFDA. This site is unofficial and independent of the FDA.