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Surgical Instruments

🏥 Medical Devices • 7,015 recalls

Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.

Olympus Corporation of the Americas

Class I - Dangerous

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

Feb 25, 2026 Surgical Instruments Nationwide View Details →

CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K, CENFT27K/A, CENFT27K/B, CENFT27K/D, CENFT31K, CENFT31K/A, CENFT31K/B, CENFT31K/D

Merit Medical Systems

Class I - Dangerous

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

Feb 13, 2026 Surgical Instruments Nationwide View Details →

Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.

Olympus Corporation of the Americas

Class I - Dangerous

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

Feb 25, 2026 Surgical Instruments Nationwide View Details →

Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure.

Olympus Corporation of the Americas

Class I - Dangerous

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

Feb 25, 2026 Surgical Instruments Nationwide View Details →

BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU, H965103028070/A, H965103028070/EU, H965103028080/A, H965103028080/EU, H965103028090/A, H965103028090/EU, H965103028161/A, H965103028181/A, H965103028191/A, H965103028191/EU, H965103028201/A, H965103028211/A, H965103028220/A, H965103028230/A, H965103028240/A, H965103038181/A

Merit Medical Systems

Class I - Dangerous

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

Feb 13, 2026 Surgical Instruments Nationwide View Details →

Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.

Olympus Corporation of the Americas

Class I - Dangerous

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

Feb 25, 2026 Surgical Instruments Nationwide View Details →

DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H787103028075/A, H787103028085/A, H787103028095/A, H787103028165/A, H787103028181/A, H787103028185/A, H787103028191/A, H787103028195/A, H787103028205/A, H787103028215/A, H787103028225/A, H787103028235/A

Merit Medical Systems

Class I - Dangerous

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

Feb 13, 2026 Surgical Instruments Nationwide View Details →

Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200

Medline Industries

Class I - Dangerous

Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.

Jan 8, 2026 Surgical Instruments Nationwide View Details →

Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516; 4) DBD-IV ADMIN SET, 15DRP, 1 INJECT PORT,, Model Number: DYNDTB1530; 5) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 6, Model Number: DYNDTB1539; 6) DBD-IV ADMIN SET, 15DRP, 3 NF, 109, Model Number: DYNDTB1545; 7) IV ADMIN SET, 20DRP, 3 NF, 109, Model Number: DYNDTB2045; 8) DBD-IVADMINSET60DRP2NEEDLE-FREEVLVE96, Model Number: DYNDTB0512; 9) DBD-IVADMINSET,60DRP3 NEEDLE-FREE VLVE11, Model Number: DYNDTB0555; 10) IV ADMIN SET, 10DRP, NF,INJ, 96, Model Number: DYNDTB1022; 11) DBD-IV ADMIN SET, 15DRP, 2NF, 96, Model Number: DYNDTB1512; 12) DBD-IV ADMIN SET, 15DRP, 1NF, 92, Model Number: DYNDTB1529; 13) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 9, Model Number: DYNDTB1537; 14) DBD-IV ADMIN SET, 15DRP, SECOND, 40, Model Number: DYNDTB1540; 15) IV ADMIN SET, 20DRP, 1NF, 92, Model Number: DYNDTB2029; 16) DBD-IV EXT SET, 6.5, 1.1ML, M LUERLOCK,, Model Number: DYNDTB5077; 17) IV ADMIN SET, 10DRP, 3 NF, 109, Model Number: DYNDTB1045; 18) DBD-IVADMISET15DRP4NEEDLEFREE VLVESTPCK1, Model Number: DYNDTB1545D; 19) IV ADMIN SET15DRPFLWCTRL1NEEDLEFREE VA, Model Number: DYNDTB2524; 20) IV ADMIN SET, 10DRP, 2NF, 96, Model Number: DYNDTB1012; 21) IV ADMIN SET, 20DRP, 2NF, 96, Model Number: DYNDTB2012; 22) IV ADMIN SET, 20DRP, NF,INJ, 96, Model Number: DYNDTB2022; 23) DBD-IV EXT SET,SMBORE EXT,8,M LUERLOCK,1, Model Number: DYNDTB5081

Medline Industries

Class I - Dangerous

Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication.

Dec 31, 2025 Surgical Instruments Nationwide View Details →

Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0800934D; 3) GENERAL ENDO PACK-LF, Model Number: DYNJ0842873J; 4) OR ANGIO PACK-LF, Model Number: DYNJ43415C; 5) ANGIO PACK II, Model Number: DYNJ44066A; 6) SOUTH CATH LAB PACK, Model Number: DYNJ61978A; 7) BIOPSY ANGIO TRAY ALEX, Model Number: DYNJ63542B; 8) SURGICAL TECH KIT, Model Number: DYNJ907452; 9) ANGIOGRAPHY PACK, Model Number: DYNJC2371G; 10) SPECTRUM HEALTH CATH PACK-LF, Model Number: PHS853965G

Medline Industries

Class I - Dangerous

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Jan 7, 2026 Surgical Instruments Nationwide View Details →

Medline Surgical Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001; 2) GOWN,SIRUS,NONRNF,SETINSLV,L,20/CS, Model Number: DYNJP2001S; 3) GOWN,ECLIPSE,NONRNF,XL,ST,30/CS, Model Number: DYNJP2002; 4) GOWN,SIRUS,NONRNF,SETINSLV,XL,20/CS, Model Number: DYNJP2002S; 5) GOWN,SIRUS,NONRNF,XLN/XL,20/CS, Model Number: DYNJP2002SL; 6) GOWN,NONRNF,2XL,18/CS, Model Number: DYNJP2003; 7) GOWN,SIRUS,NONRNF,SETINSLV,2XL,18/CS, Model Number: DYNJP2003S; 8) GOWN,SIRUS,NONRNF,XLN/2XL,18/CS, Model Number: DYNJP2003SL; 9) GOWN,NONRNF,3XL,18/CS, Model Number: DYNJP2004; 10) GOWN,SIRUS,NONRNF,3XL,18/CS, Model Number: DYNJP2004S; 11) GOWN,NONRNF,SM,30/CS, Model Number: DYNJP2005; 12) GOWN,SIRUS,NONRNF,SM,30/CS, Model Number: DYNJP2005S; 13) GOWN,NONRNF,4XL,18/CS, Model Number: DYNJP2009; 14) GOWN,SIRUS,NONRNF,4XL,18/CS, Model Number: DYNJP2009S; 15) GOWN,ECLIPSE,FABRNF,L,30/CS, Model Number: DYNJP2101; 16) GOWN,SIRUS,FABRNF,L,20/CS, Model Number: DYNJP2101S; 17) GOWN,ECLIPSE,FABRNF,XL,30/CS, Model Number: DYNJP2102; 18) GOWN,SIRUS,FABRNF,XL,20/CS, Model Number: DYNJP2102S; 19) GOWN,ECLIPSE,FABRNF,2XL,18/CS, Model Number: DYNJP2103; 20) GOWN,SIRUS,FABRNF,2XL,18/CS, Model Number: DYNJP2103S; 21) GOWN,ECLIPSE,POLYRNF,L,30/CS, Model Number: DYNJP2201; 22) GOWN,SIRUS,POLYRNF,SETINSLV,L,20/CS, Model Number: DYNJP2201S; 23) GOWN,ECLIPSE,POLYRNF,XL,30/CS, Model Number: DYNJP2202; 24) GOWN,SIRUS,POLYRNF,SETINSLV,XL,20/CS, Model Number: DYNJP2202S; 25) GOWN,ECLIPSE,POLYRNF,2XL,18/CS, Model Number: DYNJP2203; 26) GOWN,SIRUS,POLYRNF,SETINSLV,2XL,18/CS, Model Number: DYNJP2203S; 27) GOWN,ECLIPSE,POLYRNF,XLN/L,28/CS, Model Number: DYNJP2204; 28) GOWN,SIRUS,POLYRNF,XLN/LG,20/CS, Model Number: DYNJP2204S; 29) GOWN,ECLIPSE,POLYRNF,XLN/XL,28/CS, Model Number: DYNJP2205; 30) GOWN,SIRUS,POLYRNF,XLN/XL,20/CS, Model Number: DYNJP2205S; 31) GOWN,ECLIPSE,POLYRNF,XLN/2XL,18/CS, Model Number: DYNJP2206; 32) GOWN,SIRUS,POLYRNF,XLN/2XL,18/CS, Model Number: DYNJP2206S; 33) DBQ-GOWN,PREVENTION PLUS,LN/L,ST,24/CS, Model Number: DYNJP2301P; 34) DBQ-GOWN,PREVENTION PLUS,XLN/XL,ST,24/CS, Model Number: DYNJP2302P; 35) DBD-GOWN,PREVENTION PLUS,XLN/2XL,ST,22/C, Model Number: DYNJP2303P; 36) DBD-GOWN,PREVENTION PLUS,L,ST,24/CS, Model Number: DYNJP2306P; 37) DBQ-GOWN,PREVENTION PLUS,XL,ST,24/CS, Model Number: DYNJP2307P; 38) DBQ-GOWN,PREVENTION PLUS,2XL,ST,22/CS, Model Number: DYNJP2308P; 39) GOWN,ORBIS,LVL 3,LRG/XLONG,ST,24/CS, Model Number: DYNJP2361P; 40) GOWN,ORBIS,LVL 3,XLONG/XLARGE,ST,24/CS, Model Number: DYNJP2362P; 41) GOWN,ORBIS,LVL 3,XLNG/XXLARGE,ST,22/CS, Model Number: DYNJP2363P; 42) GOWN,ORBIS,LVL 3,LARGE,ST,24/CS, Model Number: DYNJP2366P; 43) GOWN,ORBIS,LVL 3,XLARGE,ST,24/CS, Model Number: DYNJP2367P; 44) GOWN,ORBIS,LVL 3,XXLARGE,ST,22/CS, Model Number: DYNJP2368P; 45) GOWN,ORBIS,LVL 3,4XL,ST,20/CS, Model Number: DYNJP2369P; 46) GOWN,SIRUS,NONRNF,RAGLAN,L,ST,32/CS, Model Number: DYNJP2401; 47) GOWN,SIRUS,NONRNF,RAGLAN,XL,ST,30/CS, Model Number: DYNJP2402; 48) GOWN,SIRUS,NONRNF,RAGLAN,2XL,ST,28/CS, Model Number: DYNJP2403; 49) GOWN,SIRUS,FABRNF,RAGLAN,L,ST,30/CS, Model Number: DYNJP2501; 50) GOWN,SIRUS,FABRNF,RAGLAN,XL,ST,28/CS, Model Number: DYNJP2502; 51) GOWN,SIRUS,FABRNF,RAGLAN,2XL,ST,28/CS, Model Number: DYNJP2503; 52

Medline Industries

Class I - Dangerous

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Jan 7, 2026 Surgical Instruments Nationwide View Details →

Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) L & D PACK-LF, Model Number: DYNJ0456816O; 6) L & D PACK-LF, Model Number: DYNJ0456816P; 7) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ04692S; 8) VAGINAL DELIVERY PACK, Model Number: DYNJ16621B; 9) VAGINAL DELIVERY PACK, Model Number: DYNJ16621C; 10) DELIVERY PACK-LF, Model Number: DYNJ20546F; 11) VAGINAL DELIVERY PK, Model Number: DYNJ20979I; 12) VAGINAL DELIVERY PK, Model Number: DYNJ20979J; 13) VAGINAL DELIVERY PACK, Model Number: DYNJ24108D; 14) OB PACK-LF, Model Number: DYNJ26121I; 15) OB DELIVERY PACK, Model Number: DYNJ31024J; 16) OB DELIVERY PACK-LF, Model Number: DYNJ32139C; 17) DB VAG HYSTERECTOMY-LF, Model Number: DYNJ33590F; 18) MAJOR VAGINAL PACK, Model Number: DYNJ35488F; 19) ENS. ACCOUCHEMENT VAGINAL-LF, Model Number: DYNJ37331C; 20) VAG DELIVERY PACK, Model Number: DYNJ38481G; 21) VAG DELIVERY PACK, Model Number: DYNJ38481I; 22) VAG DELIVERY PACK, Model Number: DYNJ38481K; 23) OB PACK 2, Model Number: DYNJ39000D; 24) GYNECOLOGY VAGINAL KIT, Model Number: DYNJ40203A; 25) LABOR DELIVERY POUCH SCREEN, Model Number: DYNJ40918A; 26) L & D PACK WITHOUT INSTRUMENTS, Model Number: DYNJ44720B; 27) VAGINAL DELIVERY PACK, Model Number: DYNJ51377G; 28) FH VAG DELIVERY PK-LF, Model Number: DYNJ51794B; 29) VAGINAL DELIVERY PACK, Model Number: DYNJ55363A; 30) VAGINAL DELIVERY PACK, Model Number: DYNJ55363B; 31) MINOR VAGINAL PACK, Model Number: DYNJ61269B; 32) OB VAG DELIVERY PACK, Model Number: DYNJ61574; 33) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ61650; 34) OB-VAG PACK 9128190, Model Number: DYNJ62341; 35) HP VAGINAL DELIVERY PACK-LF, Model Number: DYNJ62402A; 36) L & D PACK, Model Number: DYNJ63216A; 37) L&D PACK, Model Number: DYNJ63757A; 38) GYN PACK DYNJ55833A, Model Number: DYNJ65145; 39) MINOR VAG PACK, Model Number: DYNJ68663; 40) UTHET TYLER OB PACK, Model Number: DYNJ68673A; 41) GYN VAGINAL PACK, Model Number: DYNJ68681; 42) VAGINAL DELIVERY PACK, Model Number: DYNJ69544A; 43) VAGINAL PACK, Model Number: DYNJ69774A; 44) LABOR & DELIVERY PACK-LF, Model Number: DYNJ84393; 45) DELIVERY PACK, Model Number: DYNJ87469A; 46) VAGINAL DELIVERY, Model Number: DYNJ901387A; 47) FLOYD DELIVERY, Model Number: DYNJ906937D; 48) OB VAGINAL MEDSTAR PACK-LF, Model Number: DYNJT3445; 49) OB PACK, Model Number: DYNJT5186; 50) VAGINAL DELIVERY KIT, Model Number: MNS13550A; 51) VAGINAL DELIVERY TRAY, Model Number: MNS7460A; 52) LABOR AND DELIVERY KIT, Model Number: MNS8950A

Medline Industries

Class I - Dangerous

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Jan 7, 2026 Surgical Instruments Nationwide View Details →
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