Browse recalls
Alert level: Class II
- 2026-01-20 · US FDA — Medical DevicesClass II
GEM Premier 5000; Part No. 00055445008. - 2026-01-20 · US FDA — Medical DevicesClass II
GEM Premier 5000 PAK; Part No. 00055407510. - 2026-01-20 · US FDA — Medical DevicesClass II
GEM Premier 5000 PAK; Part No. 00055360008. - 2026-01-20 · US FDA — Medical DevicesClass II
GEM Premier 5000; Part No. 00055445004. - 2026-01-20 · US FDA — Medical DevicesClass II
cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464 - 2026-01-20 · US FDA — Medical DevicesClass II
GEM Premier 5000; Part No. 00055415010. - 2026-01-20 · US FDA — Medical DevicesClass II
GEM Premier 5000; Part No. 00055430004. - 2026-01-20 · US FDA — Medical DevicesClass II
GEM Premier 5000; Part No: 00055415011. - 2026-01-16 · US FDA — Medical DevicesClass II
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; - 2026-01-13 · US FDA — Medical DevicesClass II
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1 - 2026-01-09 · US FDA — Medical DevicesClass II
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3) - 2026-01-09 · US FDA — Medical DevicesClass II
Diowave Laser System, REF: Diowave 250W - 2026-01-08 · US FDA — Medical DevicesClass II
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746 - 2026-01-08 · US FDA — Medical DevicesClass II
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167 - 2026-01-08 · US FDA — Medical DevicesClass II
Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LI - 2026-01-08 · US FDA — Medical DevicesClass II
Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU C - 2026-01-08 · US FDA — Medical DevicesClass II
Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESS - 2026-01-07 · US FDA — Medical DevicesClass II
See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) BREAST-HERN - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A; - 2026-01-07 · US FDA — Medical DevicesClass II
See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Mod - 2026-01-07 · US FDA — Medical DevicesClass II
Brilliance iCT; Product Code (REF): 728306; - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES INSERT PEG, Model Number: DY - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A - 2026-01-07 · US FDA — Medical DevicesClass II
Spectral CT; Product Code (REF): 728333; - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150C - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number:DYNJ56436B; - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KIT SURG ONC INSERT CENT.VENOU, Model Numb - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL PACK - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS98509 - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYN LITHOTOMY CDS, Mode - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number:DYK - 2026-01-07 · US FDA — Medical DevicesClass II
See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2) BAP NORTH ROBOTIC - 2026-01-07 · US FDA — Medical DevicesClass II
See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROT - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL9 - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: C - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Numb - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501 - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: D - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, M - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A; - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; 2) ENDO KIT W/SYRINGE, Model Number:DYKE - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/C - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P - 2026-01-07 · US FDA — Medical DevicesClass II
See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6- - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD DRIVELINE TRAY, Model Number: DM1035 - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Num - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS98 - 2026-01-07 · US FDA — Medical DevicesClass II
IQon Spectral CT; Product Code (REF): 728332; - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BUR - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Numb - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Nu - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBN - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN KNEE ARTHRO BASIC, M - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2) LVAD DRIVELINE TRAY, Model Num - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: D - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBND - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Surgical Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001; 2) GOWN,SIRUS,NONRNF,SETINSLV,L,20/CS, Model - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBND - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2) TOTE SEN OSC HAND REPAIR, Mode - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/ - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Numbe - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Numb - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BUR - 2026-01-05 · US FDA — Medical DevicesClass II
VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem - 2026-01-05 · US FDA — Medical DevicesClass II
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705 - 2025-12-31 · US FDA — Medical DevicesClass II
Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYN - 2025-12-30 · US FDA — Medical DevicesClass II
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45 - 2025-12-26 · US FDA — Medical DevicesClass II
Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. - 2025-12-24 · US FDA — Medical DevicesClass II
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit - 2025-12-24 · US FDA — Medical DevicesClass II
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legen - 2025-12-23 · US FDA — Medical DevicesClass II
Focalyx Fusion - 2025-12-19 · US FDA — Medical DevicesClass II
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 - 2025-12-19 · US FDA — Medical DevicesClass II
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000 - 2025-12-19 · US FDA — Medical DevicesClass II
Alphenix INFX-8000F, interventional fluoroscopic x-ray system - 2025-12-19 · US FDA — Medical DevicesClass II
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010 - 2025-12-16 · US FDA — Medical DevicesClass II
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G - 2025-12-16 · US FDA — Medical DevicesClass II
Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY C - 2025-12-16 · US FDA — Medical DevicesClass II
Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOP - 2025-12-15 · US FDA — Medical DevicesClass II
Allura Xper FD10F; Model Number: 722002; - 2025-12-15 · US FDA — Medical DevicesClass II
Allura Xper FD10/10; Model Number: 722027; - 2025-12-15 · US FDA — Medical DevicesClass II
Allura Xper FD20; Model Number: 722028; - 2025-12-15 · US FDA — Medical DevicesClass II
Product Name: Allura Xper FD10C; Model number: 722001; - 2025-12-15 · US FDA — Medical DevicesClass II
Allura Xper FD10; Model Number: 722003; - 2025-12-15 · US FDA — Medical DevicesClass II
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines) - 2025-12-15 · US FDA — Medical DevicesClass II
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines) - 2025-12-15 · US FDA — Medical DevicesClass II
Allura Xper FD10/10; Model Number: 722011;