Aesculap Inc
Center Valley, PA, US
AESCULAP, INC. appears in FDA device records in Center Valley, PA. FDA records list 269 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 119 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Aesculap Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Aesculap Implant Systems, LLC510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 269FDA records hold 269 510(k) clearances for Aesculap Inc between 1991 and 2025. The busiest year on record is 2006, with 22. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 5 |
| 1992 | 3 |
| 1993 | 6 |
| 1994 | 15 |
| 1995 | 6 |
| 1996 | 6 |
| 1997 | 8 |
| 1998 | 11 |
| 1999 | 6 |
| 2000 | 7 |
| 2001 | 16 |
| 2002 | 12 |
| 2003 | 10 |
| 2004 | 9 |
| 2005 | 5 |
| 2006 | 22 |
| 2007 | 8 |
| 2008 | 11 |
| 2009 | 6 |
| 2010 | 15 |
| 2011 | 4 |
| 2012 | 10 |
| 2013 | 6 |
| 2014 | 9 |
| 2015 | 12 |
| 2016 | 7 |
| 2017 | 6 |
| 2018 | 7 |
| 2019 | 6 |
| 2020 | 6 |
| 2021 | 4 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242762 | Aesculap Aicon® Series Container System | KCT | Substantially Equivalent | |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set | JXG | Substantially Equivalent | |
| K223596 | SQ.line KERRISON | HAE | Substantially Equivalent | |
| K214041 | Aesculap AICON Container | KCT | Substantially Equivalent | |
| K213871 | Ennovate Cervical Spinal and Occiput System | NKG | Substantially Equivalent | |
| K211572 | Aesculap Slim Clip Applier | HCI | Substantially Equivalent | |
| K203739 | ELAN 4 Electro Motor System | HBE | Substantially Equivalent | |
| K210963 | ENNOVATE Spinal System | NKB | Substantially Equivalent | |
| K202391 | DIR 800 | IZI | Substantially Equivalent | |
| K203461 | Aesculap Caiman 12 Seal and Cut Technology System | GEI | Substantially Equivalent | |
| K202938 | Aesculap Caiman 5 Seal and Cut Technology System | GEI | Substantially Equivalent | |
| K202124 | Aesculap PAS-Port Proximal Anastomosis System | FZP | Substantially Equivalent | |
| K200950 | Ventricular Catheter | JXG | Substantially Equivalent | |
| K192056 | JJ Series Container System | KCT | Substantially Equivalent | |
| K193582 | SterilContainer S2 System | KCT | Substantially Equivalent | |
| K192266 | M. Blue Adjustable Shunt System | JXG | Substantially Equivalent | |
| K183203 | ELAN 4 Tools | HBE | Substantially Equivalent | |
| K190174 | Miethke Shunt System GAV 2.0 and SA 2.0 Valves | JXG | Substantially Equivalent | |
| K182414 | Aesculap® SterilContainer(TM) S2 System | KCT | Substantially Equivalent | |
| K183180 | Caiman 5 Maryland | GEI | Substantially Equivalent | |
| K182527 | ELAN 4 Tools | HBE | Substantially Equivalent | |
| K182032 | SterilContainer S System | KCT | Substantially Equivalent | |
| K172907 | ELAN 4 Air Motor System | HBB | Substantially Equivalent | |
| K172709 | ELAN 4 Electro Motor System Tools | HBE | Substantially Equivalent | |
| K180433 | ENNOVATE® | NKB | Substantially Equivalent | |
| K180914 | Aesculap Slim Clip Applier | HCI | Substantially Equivalent | |
| K180321 | Aesculap Optilene Nonabsorbable Suture | GAW | Substantially Equivalent | |
| K170683 | Aesculap Video Assisted Thoracic Surgery (VATS) INstruments | GCJ | Substantially Equivalent | |
| K172850 | SterilContainer with PrimeLine Pro Lid | KCT | Substantially Equivalent | |
| K173271 | Aesculap Slim Clip Applier Forceps | HCI | Substantially Equivalent | |
| K171001 | Monosyn Quick Synthetic Absorbable Surgical Suture | GAM | Substantially Equivalent | |
| K162815 | SterilContainer S System | KCT | Substantially Equivalent | |
| K170661 | Novosyn Quick Absorbable Suture | GAM | Substantially Equivalent | |
| K161853 | proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System | JXG | Substantially Equivalent | |
| K162134 | ENNOVATE Spinal System | NKB | Substantially Equivalent | |
| K152960 | ELAN 4 Motor System | HBC | Substantially Equivalent | |
| K153700 | Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments | OLO | Substantially Equivalent | |
| K160393 | AdTec | GCJ | Substantially Equivalent | |
| K153629 | ArcadiusXP C Spinal System | OVE | Substantially Equivalent | |
| K153396 | Aesculap OrthoPilot Next Generation | OLO | Substantially Equivalent | |
| K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture | GAR | Substantially Equivalent | |
| K151865 | PremiPatch PTFE Pledget | DXZ | Substantially Equivalent | |
| K151938 | S4 Cervical Spinal and Occiput Systems | NKG | Substantially Equivalent | |
| K151242 | SterilContainer S | KCT | Substantially Equivalent | |
| K143729 | SterilContainer S | KCT | Substantially Equivalent | |
| K151056 | Aesculap T-Space PEEK and XP Spinal System | MAX | Substantially Equivalent | |
| K151858 | Caiman Seal and Cut Technology | GEI | Substantially Equivalent | |
| K151696 | Caiman Seal and Cut Technology | GEI | Substantially Equivalent | |
| K142970 | SterilContainer S System | KCT | Substantially Equivalent | |
| K150544 | Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System | JWH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9610612 | 3002806315 | AESCULAP AG | AM AESCULAP PLATZ, TUTTLINGEN, DONAU Baden-Wurttemberg D-78532 DE | 2026 | and 402 more, listed in full below |
| 2916714 | 2916714 | AESCULAP, INC. | 3773 CORPORATE PKWY., CENTER VALLEY, PA 18034 US | 2026 | and 308 more, listed in full below |
| 3003587896 | 3003587896 | AESCULAP, INC. | 615 LAMBERT POINTE DR., HAZELWOOD, MO 63042 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EIFAccessories, Retractor, Dental
- DWHBlade, Saw, Surgical, Cardiovascular
- EKJBurnisher, Operative
- EKICarrier, Amalgam, Operative
- EKHCarver, Dental Amalgam, Operative
- EIKCarver, Wax, Dental
- EMLChisel, Bone, Surgical
- EMMChisel, Osteotome, Surgical
- EEFClamp, Rubber Dam
- DXCClamp, Vascular
- ECNClamp, Wire, Orthodontic
- DSSClip, Vascular
- EKGCondenser, Amalgam And Foil, Operative
- EMKCurette, Surgical, Dental
- DWPDilator, Vessel, Surgical
- EMJElevator, Surgical, Dental
- EKCExcavator, Dental, Operative
- EKBExplorer, Operative
- EMIFile, Bone, Surgical
- EFKForceps, Articulation Paper
- EFLForceps, Dressing, Dental
- EMHForceps, Rongeur, Surgical
- EJGForceps, Rubber Dam Clamp
- EMGForceps, Tooth Extractor, Surgical
- EJEFrame, Rubber Dam
- EJBHandle, Instrument, Dental
- EMDHemostat, Surgical
- EMQHoe, Periodontic
- DXTInjector And Syringe, Angiographic
- EKFInstrument, Contouring, Matrix, Operative
- EKDInstrument, Cutting, Operative
- EIYInstrument, Filling, Plastic, Dental
- ECPInstrument, Ligature Tucking, Orthodontic
- DZNInstruments, Dental Hand
- DWSInstruments, Surgical, Cardiovascular
- EJZKnife, Margin Finishing, Operative
- EMOKnife, Periodontic
- EMFKnife, Surgical
- CCWLaryngoscope, Rigid
- EMPMarker, Periodontic
- EAXMirror, Mouth
- DZMNeedle, Dental
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- EJYPliers, Operative
- EKRPlugger, Root Canal, Endodontic
- EIXProbe, Periodontic
- BTAPump, Portable, Aspiration (Manual Or Powered)
- EKPReamer, Pulp Canal, Endodontic
- EISRemover, Crown
- EIGRetractor, All Types
- DWISaw, Electrically Powered
- EMNScaler, Periodontic
- EIRScissors, Collar And Crown
- EGNScissors, Surgical Tissue, Dental
- EKKSpreader, Pulp Canal Filling Material, Endodontic
- EICSyringe, Periodontic, Endodontic, Irrigating
- BWNTable And Attachments, Operating-Room
- EHYTray, Impression, Preformed
- EBRUnit, Suction Operatory
- DZCWire, Orthodontic
Recall records
Showing 25 of 119| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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 | There is the potential for the length of the trocar shaft to be too long. | Class II | Open, Classified | |
| 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 | It was determined there is the potential of silicone fragments detaching from the yellow sealing component. | Class II | Open, Classified | |
| 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 | It was determined there is the potential of silicone fragments detaching from the yellow sealing component. | Class II | Open, Classified | |
| 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 | It was determined there is the potential of silicone fragments detaching from the yellow sealing component. | Class II | Open, Classified | |
| 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 | It was determined there is the potential of silicone fragments detaching from the yellow sealing component. | Class II | Open, Classified | |
| Z-0027-2026 | AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R. | Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard." | Class II | Open, Classified | |
| Z-0026-2026 | AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R. | Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard." | Class II | Open, Classified | |
| 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. | The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | Class II | Open, Classified | |
| 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. | The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | Class II | Open, Classified | |
| 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 | The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | Class II | Open, Classified | |
| 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 | The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | Class II | Open, Classified | |
| 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. | The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | Class II | Open, Classified | |
| Z-2139-2024 | Aeos Robotic Digital Microscope, Product Code: PV010 | 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. | Class II | Open, Classified | |
| Z-1247-2024 | DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures. | The sterile blister packaging may be damaged, and sterility may be compromised. | Class II | Open, Classified | |
| Z-1246-2024 | DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures. | The sterile blister packaging may be damaged, and sterility may be compromised. | Class II | Open, Classified | |
| Z-1245-2024 | DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures. | The sterile blister packaging may be damaged, and sterility may be compromised. | Class II | Open, Classified | |
| Z-1244-2024 | DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures. | The sterile blister packaging may be damaged, and sterility may be compromised. | Class II | Open, Classified | |
| Z-1243-2024 | DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures. | The sterile blister packaging may be damaged, and sterility may be compromised. | Class II | Open, Classified | |
| Z-0867-2024 | MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM" | 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. | Class II | Open, Classified | |
| Z-0866-2024 | MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM"; | 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. | Class II | Open, Classified | |
| Z-2518-2023 | For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R | 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. | Class II | Open, Classified | |
| Z-2146-2023 | Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610 | Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610. | Class II | Open, Classified | |
| Z-1569-2023 | 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 | 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. | Class II | Open, Classified | |
| Z-1430-2023 | 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 | Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607. | Class II | Open, Classified | |
| Z-1638-2022 | Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014 | Potential for the incorrect screw to be included in the package. | Class II | Open, Classified |
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