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Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431J; 4) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 5) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431L; 6) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431N; 7) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O; 8) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A; 9) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116A; 10) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116G; 11) ROBOTIC PACK, Model Number: DYNJ04135B; 12) MINOR LITHOTOMY PACK, Model Number: DYNJ04382J; 13) NBMC D & C PACK-LF, Model Number: DYNJ0665843C; 14) D&C PACK-LF, Model Number: DYNJ22567G; 15) D&C PACK-LF, Model Number: DYNJ22567I; 16) D&C PACK-LF, Model Number: DYNJ22567J; 17) D&C PACK-LF, Model Number: DYNJ22567K; 18) D&C HYSTEROSCOPY PACK, Model Number: DYNJ38805B; 19) D AND C, Model Number: DYNJ41272B; 20) D AND C, Model Number: DYNJ41272C; 21) OB PACK, Model Number: DYNJ42884; 22) D&C/GYN PACK, Model Number: DYNJ47713A; 23) PERI GYN PACK, Model Number: DYNJ55377D; 24) ANTERIOR CERVICAL-LF, Model Number: DYNJ58344; 25) D&C PACK, Model Number: DYNJ67214D; 26) D&C PACK, Model Number: DYNJ67214F; 27) D&C PACK, Model Number: DYNJ67214G; 28) D&C PACK, Model Number: DYNJ67214I; 29) LITHOTOMY PACK, Model Number: DYNJ80765C; 30) GYN PACK, Model Number: DYNJ83475; 31) D AND C PACK, Model Number: DYNJ87468; 32) D&C-ASC, Model Number: DYNJ900465C; 33) D&C-ASC, Model Number: DYNJ900465D; 34) D&C-ASC, Model Number: DYNJ900465F; 35) GYN LITHOTOMY-LF, Model Number: DYNJ902711L; 36) GYN LITHOTOMY-LF, Model Number: DYNJ902711N; 37) D&C, Model Number: DYNJ906947C; 38) PACK PERI GYN DSMC, Model Number: DYNJT6424

FDA Recall
Open, Classified ·Product code OKV·January 7, 2026

Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050

FDA Recall
Open, Classified ·Thoratec Corp.·Product code DSQ·August 7, 2023

Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Configuration, Rev H The Bigfoot Unity Diabetes Management System that include the Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting Insulin Pen Cap [LCAP]) integrates continuous monitoring with insulin dose recommendations. The Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting Insulin Pen Cap [LCAP]) are part of the Bigfoot Unity Diabetes Management System.

FDA Recall
Open, Classified ·BIGFOOT BIOMEDICAL·Product code QLG·May 21, 2025

Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS830039AD; 2) FETAL SURGERY CDS-LF, Pack Number CDS840214P ; 3) OB PROCEDURE-LF , Pack Number CDS981335C ; 4) ROBOTIC PACK-LF , Pack Number CDS981757P ; 5) GYN ROBOTIC , Pack Number CDS981826J ; 6) ROBOTIC CDS , Pack Number CDS981882Q ; 7) ROBOTIC CDS , Pack Number CDS981882R ; 8) ROBOTIC UROLOGY CDS , Pack Number CDS981984I ; 9) D&C CDS-WRMC, Pack Number CDS982331N ; 10) LITHOTOMY CDS-WRMC, Pack Number CDS982333O ; 11) LITHOTOMY CDS-WRMC, Pack Number CDS982333P ; 12) DEPAUL DAVINCI CDS, Pack Number CDS982377G ; 13) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397B ; 14) BAP NORTH ROBOTIC SURGERY CDS , Pack Number CDS982407N ; 15) GYN/ABDOMINAL , Pack Number CDS982725M ; 16) ROBOTIC CDS , Pack Number CDS982888D ; 17) ROBOTIC CDS , Pack Number CDS982888F ; 18) ROBOTIC CDS , Pack Number CDS982888G ; 19) ROBOTIC CDS , Pack Number CDS983028D ; 20) ZALE PUMP CDS , Pack Number CDS983187F ; 21) CUH UROLOGY ROBOTIC CDS , Pack Number CDS983190L ; 22) ROBOTIC PROSTATECTOMY CDS , Pack Number CDS983216I ; 23) ROBOTIC CDS-LF, Pack Number CDS983258O ; 24) ROBOTIC CDS-LF, Pack Number CDS983258Q ; 25) VAGINAL MINOR , Pack Number CDS983268K ; 26) CUH GEN/GYN ROBOTIC CDS , Pack Number CDS983375K ; 27) ROBOTIC CDS , Pack Number CDS983399D ; 28) GYN VAGINAL CDS , Pack Number CDS983528L ; 29) GYN VAGINAL CDS , Pack Number CDS983528M ; 30) CELEBRATION ROBOTIC CDS , Pack Number CDS983612C ; 31) DAVINCI PROSTATECTOMY CDS , Pack Number CDS983667F ; 32) ROBOTIC LAP NISSEN CDS, Pack Number CDS983687F ; 33) OB CDS, Pack Number CDS983854B ; 34) OB/GYN CDS, Pack Number CDS984173F ; 35) GROTH VAGINAL , Pack Number CDS984201V ; 36) ROBOTIC LITHOTOMY , Pack Number CDS984454N ; 37) DAVINCI ROBOTIC CDS , Pack Number CDS984463C ; 38) DAVINCI CDS UCC-LF, Pack Number CDS984663G ; 39) GYN CDS , Pack Number CDS984860G ; 40) OB DELIVERY CDS , Pack Number CDS985027I ; 41) OB/GYN CDS RICE , Pack Number CDS985256C ; 42) OB/GYN CDS RICE , Pack Number CDS985256D ; 43) OB/GYN CDS RICE , Pack Number CDS985256F ; 44) OB CDS-LF , Pack Number CDS985320C ; 45) OB, Pack Number CDS985506D ; 46) OB, Pack Number CDS985506F ; 47) OB, Pack Number CDS985506G ; 48) OB, Pack Number CDS985506I ; 49) GYN LAPAROSCOPY , Pack Number CDS985519L ; 50) KIT ROBOTICS GYN, Pack Number DYKMBNDL109A ; 51) TRAY HYSTEROSALPINGOGRAM, Pack Number DYNDE1010A ; 52) PERI-GYN PACK-LF, Pack Number DYNJ0038057; 53) ROBOTICS PACK-LF, Pack Number DYNJ0038258B ; 54) DAVINCI PACK-LF , Pack Number DYNJ0042750; 55) ROBOTICS PACK-LF, Pack Number DYNJ0046667A ; 56) ROBOTIC PACK-LF , Pack Number DYNJ0048814I ; 57) NILES LAP PELVIC PACK-LF, Pack Number DYNJ0101440F ; 58) OB DELIVERY PACK-LF , Pack Number DYNJ0103039B ; 59) D AND C PACK-LF , Pack Number DYNJ0161028C ; 60) D AND C PACK-LF , Pack Number DYNJ0161028F ; 61) D AND C PACK-LF , Pack Number DYNJ0161028G ; 62) PELVISCOPY (SMSC) PACK-LF , Pack Number DYNJ0161619D ; 63) LAP SUPRA CERVICAL PACK-LF, Pack Number DYNJ0161811C ; 64) ROBOT PACK, Pack Number DYNJ01823F ; 65) ROBOTICS PACK-LF, Pack Number DYNJ0193529A ; 66) DELIVERY ROOM PACK-LF , Pack Number DYNJ0287784R ; 67) OB PACK , Pack Number DYNJ03387A ; 68) PERI GYN PACK-LF, Pack Number DYNJ0362432L ; 69) PERI GYN PACK-LF, Pack Number DYNJ0362432M ; 70) OB PACK-LF, Pack Number DYNJ0367126L ; 71) OB PACK-LF, Pack Number DYNJ0367126M ; 72) OB PACK-LF, Pack Number DYNJ0367126N ; 73) BIRTHING PACK-LF, Pack Number DYNJ0367360K ; 74) BIRTHING PACK-LF, Pack Number DYNJ0367360L ; 75) OB DELIVERY PACK-LF , Pack Number DYNJ0374609J ; 76) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378293K ; 77) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378634F ; 78) GENERAL MATERNITY PACK-LF , Pack Number DYNJ0382586I ; 79) ANT CERVICAL DISKECT PACK-LF, Pack Number DYNJ0399835M ; 80) BIRTHING PACK-LF, Pack Number DYNJ0409968D ; 81) AOP/VAGINAL MAJOR PACK-LF , Pack Number DYNJ

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OKV·April 8, 2024

MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 3) BASIC BACK CDS, REF CDS780147N; 4) INSTRUMENTED BACK CDS, REF CDS780148Q; 5) INSTRUMENTED BACK CDS, REF CDS780148R; 6) TOTAL HIP, REF CDS920027W; 7) TOTAL HIP, REF CDS920027X; 8) TOTAL HIP, REF CDS920027Y; 9) TOTAL KNEE CDS-LF, REF CDS940047AF; 10) TOTAL KNEE CDS-LF, REF CDS940047AG; 11) TOTAL HIP CDS-LF, REF CDS940048AF; 12) TOTAL HIP CDS-LF, REF CDS940048AG; 13) TOTAL HIP CDS-LF, REF CDS940048AI; 14) TOTAL KNEE, REF CDS940072W; 15) TOTAL KNEE, REF CDS940072Y; 16) TOTAL KNEE REPLACEMENT CDS, REF CDS940823AB; 17) TOTAL KNEE CDS, REF CDS940842Y; 18) TOTAL HIP CDS, REF CDS940843AA; 19) FRACTURE TABLE-LF, REF CDS940857K; 20) FRACTURE TABLE-LF, REF CDS940857L; 21) EXTREMITY-LF, REF CDS940860P; 22) EXTREMITY-LF, REF CDS940860Q; 23) KNEE/SHOULDER, REF CDS940911Q; 24) TOTAL HIP CDS, REF CDS940963Y; 25) SHOULDER CDS, REF CDS941065L; 26) TOTAL JOINT-LF, REF CDS941167M; 27) TOTAL JOINT-LF, REF CDS941167N; 28) LOWER EXTREMITY CDS-LF, REF CDS980666I; 29) LOWER EXTREMITY CDS-LF, REF CDS980666J; 30) TOTAL HIP-LF, REF CDS980788O; 31) TOTAL HIP-LF, REF CDS980788P; 32) EXTREMITY KIT, REF CDS981314R; 33) EXTREMITY KIT, REF CDS981314S; 34) ORIF HIP KIT, REF CDS981318T; 35) ORIF HIP KIT, REF CDS981318U; 36) TOTAL HIP KIT, REF CDS981320V; 37) TOTAL HIP KIT, REF CDS981320W; 38) TOTAL KNEE KIT, REF CDS981323AA; 39) TOTAL KNEE KIT, REF CDS981323Y; 40) BI LATERAL KNEE KIT, REF CDS981324T; 41) UPPER EXTREMITY CDS-LF, REF CDS981564G; 42) UPPER EXTREMITY CDS-LF, REF CDS981564I; 43) LAMI, REF CDS981886X; 44) CRANIOTOMY CDS, REF CDS981888W; 45) CRANIOTOMY CDS, REF CDS981888X; 46) TOTAL KNEE CDS, REF CDS981926D; 47) TOTAL KNEE PROCEDURE-LF, REF CDS982082F; 48) BHMC SYSTEM HIP KIT, REF CDS982396N; 49) BAPTIST NORTH TOTAL KNEE CDS, REF CDS982404M; 50) BAP NORTH SHOULDER CDS, REF CDS982406M; 51) BAP NORTH UNIV EXTREMITY CDS, REF CDS982408K; 52) TOTAL KNEE CDS, REF CDS982823Q; 53) LOWER EXTREMITY CDS-LF, REF CDS982927M; 54) LUMBAR LAMINECTOMY CDS-LF, REF CDS982928O; 55) TOTAL HIP REPLACEMENT CDS-LF, REF CDS982929K; 56) TOTAL KNEE REPLACEMENT CDS-LF, REF CDS982931L; 57) UPPER EXTREMITY-LF, REF CDS982932K; 58) LOWER EXTREMITY CDS, REF CDS982943Q; 59) LOWER EXTREMITY CDS, REF CDS982943R; 60) LOWER EXTREMITY CDS, REF CDS982943S; 61) TOTAL KNEE, REF CDS982986T; 62) SPECIALIZED HIP CDS, REF CDS983030V; 63) EXTREMITY CDS, REF CDS983031Q; 64) ZALE SPINE CDS, REF CDS983182J; 65) ZALE SPINE CDS, REF CDS983182K; 66) ZALE CRANIOTOMY CDS, REF CDS983188K; 67) DR GILL'S CDS, REF CDS983189G; 68) ZALE TOTAL KNEE CDS, REF CDS983194I; 69) ZALE TOTAL KNEE CDS, REF CDS983194J; 70) ZALE TOTAL KNEE CDS, REF CDS983194K; 71) ZALE TOTAL KNEE CDS, REF CDS983194L; 72) ZALE TOTAL HIP CDS, REF CDS983195I; 73) ZALE TOTAL HIP CDS, REF CDS983195J; 74) ZALE TOTAL HIP CDS, REF CDS983195K; 75) ZALE EXTREMITY CDS, REF CDS983199K; 76) ZALE TOTAL SHOULDER CDS, REF CDS983203J; 77) ZALE TOTAL SHOULDER CDS, REF CDS983203K; 78) ZALE TOTAL SHOULDER CDS, REF CDS983203L; 79) ORTHO EXTREMITY CDS, REF CDS983408G; 80) ORTHO-CV CDS, REF CDS983415G; 81) PODIATRY CDS, REF CDS983416D; 82) PODIATRY CDS, REF CDS983416G; 83) ORTHO EXTREMITY, REF CDS983468O; 84) LUMBAR LAMINECTOMY NEURO CDS, REF CDS983476J; 85) SITTING CERVICAL CDS, REF CDS983480G; 86) ORTHO SPINE, REF CDS983482L; 87) ARTHROSCOPY SHOULDER, REF CDS983485L; 88) EXTREMITY-LF, REF CDS983487K; 89) ACL-LF, REF CDS983490M; 90) PODIATRY CDS, REF CDS983610L; 91) TOTAL JOINT-LF, REF CDS983863F; 92) UPPER EXTREMITY CDS, REF CDS983907K; 93) UPPER EXTREMITY CDS, REF CDS983907L; 94) LOWER EXTREMITY CDS, REF CDS983909O; 95) LOWER EXTREMITY CDS, REF CDS983909P; 96) GENERAL ORTHO CDS, REF CDS983915L; 97) GENERAL ORTHO CDS, REF CDS983915M; 98) MAJOR ORTHO, REF CDS984253L; 99) LOWER EXTREMTIY, REF CDS984254K; 100) LOWER EXTREMTIY, REF CDS98425

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OJH·October 9, 2024

Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A; 3) SOL-M Red Cap, Model No. 110101150020, UPC N/A 4) SOL-M Syringe Tip Cap Tray, Black, Model Number STCT01, UPC N/A

FDA Recall
Open, Classified ·Sol-Millennium Medical Inc.·Product code KYW·May 9, 2024

ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20325-206; Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 20325-207; ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Set for Fujifilm Scopes, REF: 20325-248; Hybrid CO2 Tubing/Cap Set for Fujinon Scopes, REF: 20325-208

FDA Recall
Open, Classified ·Erbe Medical, LLC·Product code FEQ·March 31, 2026

30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning Spiros Closed Male Luer, Red Cap, REF: 20130-01; Spinning Spiros, Closed Male Luer, REF: CH2000S; Spinning Spiros Closed Male Luer, 10 units, REF: CH2000S-10; Spinning Spiros Closed Male Luer, Red Cap, REF: CH2000S-C; Spiros, Closed Male Luer w/Red Cap, 10 Units, RES: CH2000SC-10; Spiros, Closed Male Luer w/Red Cap, 5 Units, REF: CH2000SC-5; Spinning Spiros Closed Male Luer, Purple Cap, REF: CH2000S-PC; Conector macho cerrado Spinning Spiros, tapon purpura, REF: 034-CH2000S-PC; Spiros, Purple Cap, Drop-In Priming Cap, REF: CH2000S-PCP; Spinning Spiros Closed Male Luer w/Red Cap, REF: CH3515; Spinning Spiros Closed Male Luer, REF: Z7072

FDA Recall
Open, Classified ·ICU Medical, Inc.·Product code FPA·August 31, 2020

30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger, REF: CL3011; 31" (79 cm) Appx 3.4 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Bag Hanger, REF: CL3011T; 40" (102 cm) Appx 4.9 ml, Admin Set w/ChemoLock w/Red Cap, 20 Drop In-Line Drip Chamber, Spiros, Bag Hanger, Drop-In Red Cap, REF: CL3020; 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros, Hanger, Drop-In Red Cap, REF: CL3028; 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros, Bag Hanger, Drop-In Red Cap, REF: CL3028T; 42" (107 cm) Appx 5.2 ml, Admin Set w/20 Drop In-Line Chamber, ChemoLock w/Red Cap, Spiros, Bag Hanger, Drop-In Red Cap, REF: CL3361; Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock; Spinning Spiros w/Red Cap, REF: CL3538; Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, Spiros; ChemoLock; ChemoLock Universal Vented Vial Spike; Bag Hanger, REF CL3929; 8.5" (22 cm) Appx 1.0 ml, Ext Set w/MicroClave Clear, ChemoLock Port, Spiros w/Red Cap, Clamp, REF: CL3931; 7.5" (19 cm) Appx 1.1 ml, Bifuse Ext Set w/ChemoLock Port, ChemoClave, Spiros, 2 Clamps, REF: CL3932; 30 IN(76cm)APPX 2.1ml, EXT SET w/ChemoLock w/RED CAP, Spiros RED CAP, REF: CL3935; Oncology Kit w/ChemoLock w/ChemoClave; Spinning Spiros w/ Red Cap, REF: CL3941; Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock w/Red Cap, Vented Cap; ChemoLock Port w/Bag Spike; Spiros w/Red Cap, REF: CL3946; Oncology Kit, ChemoLock Bag Spike w/Additive Port, Vented Cap, Spiros, REF: CL3948; Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros, ChemoLock, Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960; Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros, ChemoLock, Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960T; 60" (152 cm) Appx 7.4 ml, Admin Set w/ChemoLock w/Red Cap, 20 Drop In-Line Chamber, Spiros w/Red Cap, Bag Hanger, REF: CL4100; 30" (76 cm) Appx 3.6 ml, Admin Set w/20 Drop In-Line Drip Chamber, ChemoLock Additive Port, Spiros w/Red Cap, REF: CL4131; 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer, REF: CL4151; 31" (79 cm) Appx 3.4 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, Spiros w/Red Cap, Drop-In ChemoLock Injector, Bag Hanger, REF: CL3978

FDA Recall
Open, Classified ·ICU Medical, Inc.·Product code ONB·August 31, 2020

3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning Spiros, Red Cap, REF: CH2005; 10mL Syringe w/Spinning Spiros, Red Cap, REF: CH2010; 20mL Syringe w/Spinning Spiros, Red Cap, REF: CH2020; 30mL Syringe w/Spinning Spiros, Red Cap, REF: CH2030; 60mL Syringe w/Spinning Spiros, Red Cap, REF: CH2060; 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger, REF: CH3011; 31" (79 cm) Appx 3.3 ml, Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros w/Red Cap, Hanger, REF: CH3011-C; 40 IN (102 cm) App 4.8 ml, Admin Set, 20 Drop, 2 Spiros, Bag Hanger, REF: CH3020; 14 IN (36 cm) App 4.8 ml, Bifuse Add-On Set, Spiros w/Red Cap, Bag Spike, REF: CH3033; 5" (13 cm) Bag Spike Adapter w/Spiros w/Red Cap, Vented Cap, REF: CH3034; 30" (76 cm) Appx 5.9 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, 0.2 Micron Filter, Spiros w/Red Cap, Hanger, REF: CH3128; Oncology Kit w/60" (152 cm) Appx 2.3 ml, Smallbore Ext Set w/Spiros, Anti-Siphon Valve, ChemoClave, Clamp, Rotating Luer, Double ChemoClave Syringe Transfer Set, Spiros w/Red Cap, REF: CH3606; 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps, REF: CH3625; 86" (218 cm) Appx 10.4 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, REF: CH3642; Oncology Kit w/40" (102 cm) Appx 4.7 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger, Double ChemoClave Syringe Transfer Set, REF: CH3677; 5.5" (14 cm) Appx 0.55 ml, Smallbore Trifuse Ext Set w/3 ChemoClave, Spiros w/Red Cap, 3 Clamps, REF: CH3700; 50 IN (127 cm) Appx 6.4 ml, Ext Set w/ChemoClave, Spiros w/Red Cap, Clamp, REF: CH3703; 16 IN (41 cm) Appx 1.6 ml, Ext Set, ChemoClave, Spiros w/Red Cap, REF: CH3715; Oncology Kit, Ext w/Spiros, Grad Conn, 2 Vial Spikes w/Clave, Spinning Spiros , REF: CH3929; Oncology Kit, w/Ext, MicroClave, Clave, Grad Conn, Transfer, Spiros, Vial Spike, Clave, REF: CH3932; Oncology Kit, 12 IN Ext, Spiros, Graduated Adapter, 2 ChemoClave w/Vial Spike, Spiros, REF: CH3943; Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter, ChemoClave Vented Vial Spike, 20mm, ChemoClave Vented Vial Spike, 13mm, REF: CH3944; Oncology Kit, 16 IN (41 cm) Ext Set, ChemoClave, Graduated Conn, 2 ChemoClave w/Vial Spike, Spiros, REF: CH3946; Oncology Kit, 21" (53 cm) Appx 3.2 ml, Ext Set w/Spiros w/Red Cap, Graduated Adapter, Locking Universal Vented Vial Spike w/ChemoClave, Closed Vial Spike, 13mm w/ChemoClave, Spinning Spiros w/Red Cap, REF: CH3949; 46" (117 cm) 50 ml, Diluent Set for Channel 2 w/20 Drop Drip Chamber, Spiros, REF: CH4002

FDA Recall
Open, Classified ·ICU Medical, Inc.·Product code ONB·August 31, 2020

Product: STA Liatest D-Di; REF: 00515;

FDA Recall
Open, Classified ·Diagnostica Stago, Inc.·Product code DAP·September 12, 2025

Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA - Liatest D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R, STA Compact and STA Satellite analyzers by professional laboratory personnel. The STA - Liatest D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No

FDA Recall
Open, Classified ·Diagnostica Stago, Inc.·Product code DAP·February 5, 2026

D-Dimer Test

FDA Recall
Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DAP·November 3, 2025

VIDAS DEX@, Dimer Exclusion II, REF 30455-01

FDA Recall
Open, Classified ·bioMerieux, Inc.·Product code DAP·September 22, 2021

ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;

FDA Recall
Open, Classified ·Erbe Medical, LLC·Product code OCX·March 31, 2026

5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip Chamber, Clave, Spiros, REF: CH3035; 40" (102 cm) Appx 4.5 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Hanger, REF: CH3135; 14" (36 cm) Appx 4.8 ml, Bifuse Add-On Set w/Spiros w/Red Cap, Bag Spike, 3 Clamps (Blue, 2 White), Vented Cap, Drop-In Spiros w/Red Cap, REF: CH3156; 114" Bifuse Primary Set w/2 Spiros, Bag Spike, 2 20 Drop In-line Drip Chamber, Clave, Bag Hanger, REF: CH3240; 18 IN (46 cm) Appx 2.9 ml, Add-On Set w/Spiros, Clave Spike, Clamp, Cap, REF: CH3290; 27" (69 cm) Appx 5.2 ml, Bifuse Add-On Set w/15 Drop Drip Chamber, Spiros w/Red Cap, Check Valve, Vented Cap, Bag Hanger, REF: CH3294; Secondary IV Oncology Kit, REF: CH3322; 30 IN (76 cm) Appx 1.8 ml) Ext Set w/2 Spiros, 2 Red Caps, Clamp, REF: CH3327; 40" (102 cm) Appx 4.6 ml, Admin Set, 2 Spiros w/2 Red Caps, 20 Drop In-Line Drip Chamber, 2 Bag Hangers, REF: CH3373; Oncology Kit w/Spiros, Red Cap, Bag Spike w/Clave Additive Port, REF: CH3397; 45" (114 cm) Appx 5.8 ml, Ext Set w/MicroClave, 2 Clave, Spiros w/Red Cap, 2 Clamps, REF: CH3403; Oncology Kit w/20" (51 cm) Ext Set w/MicroClave, Graduated Connector, Transfer Set w/Clave Additive Port, Spiros, Red Cap, 13mm Vial Spike w/Clave, REF: CH3507; Oncology Kit w/Clave Universal Vented Vial Spike, Spinning Spiros w/Red Cap, REF: CH3546; 22" (56 cm) Add-On 150 ml Burette Set (MicroClave, No Shut-Off), w/Spiros, 2 Clamps, Vented Cap, REF: CH3554; 4.5 IN (11 cm) Appx 0.43 ml, Ext Set, Spiros w/Red Cap, REF: CH3559; Oncology Kit w/Spinning Spiros, C-Clip, Red Cap, REF: CH3581; 5 IN (13 cm) Appx 0.57 ml, Ext Set, Anti-Siphon Valve, Spiros, REF: CH3582; Oncology Kit w/Spinning Spiros w/Red Cap, C-Clip; Priming Cap, REF: CH3589; 77" (196 cm) Appx. 9.4 ml, Admin Set w/2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber, Bag Hanger, REF: CH3639; 22" (56 cm) Appx 5.6ml, Ext Set, Trifuse w/4 Clave Clear, Spiros w/Red Cap, 1.2 Micron Filter, 4 Clamps, REF: CH3770; 6.5 IN (17 cm) Appx 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros, Red Cap, REF: CH3771; 47" (119 cm) 50 ml Diluent Set for Channel 2 w/20 Drop In-Line Drip Chamber, 2 Spiros, REF: CH4001; 47" (119 cm) 50 ml Diluent Set For Channel 2 w/Bag Spike w/MicroClave Additive Port, Spiros, REF: CH4009; 30" (76 cm) Appx 5.9 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, 0.2 Micron Filter, Spiros, Hanger, REF: Z7100; 30" (76 cm) 50 ml Diluent Set for Channel 2 w/Spiros, REF: CH4006; 60 IN(152cm)APPX 0.45ml,SMALLBORE EXT,MicroCLAVE,Spiros, REF: Z7040; 6" (15 cm) Appx 0.55 ml, Smallbore Trifuse Ext Set w/3 MicroClave, 3 Clamps, Spiros, REF: Z7151

FDA Recall
Open, Classified ·ICU Medical, Inc.·Product code FPA·August 31, 2020

Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 Software Version: N/A Product Description: Locking Cap Component: No

FDA Recall
Open, Classified ·SEASPINE ORTHOPEDICS CORPORATION·Product code NKB·October 29, 2024

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

FDA Recall
Open, Classified ·Aesculap Inc·Product code GCJ·September 24, 2025

Stay Safe Cap

FDA Recall
Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDJ·October 10, 2023

Burlington Medical, Caps.

FDA Recall
Open, Classified ·Burlington Medical, LLC·Product code IWO·February 11, 2026