Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

1951–1975 of 52931

HighFDA (Devices)·Z-1416-2026·2026-02-25
Urology kits recalled over sterilization equipment calibration issues
Medline is recalling 59 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBNDL106A; 3) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188; 4) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189; 5) KIT UROLOGY PERIPHERAL S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1384-2026·2026-02-25
Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues
Medline Industries, LP is recalling certain Medline Convenience Kits because equipment calibration issues may have impacted the sterility assurance level of the products.
Product
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number: DYNJ905567A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1412-2026·2026-02-25
Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues
Medline Industries, LP is recalling specific Medline Convenience Kits (CHEST/BREAST-LF) because equipment calibration issues may have impacted the sterility assurance level of the products.
Product
Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1428-2026·2026-02-25
Da Vinci 5 Surgical System Console Recalled Due to Software Error
Intuitive Surgical, Inc. is recalling the Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 due to a software error that can cause loss of user interface content on monitors.
Product
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1392-2026·2026-02-25
Oncology and biopsy kits recalled over sterilization calibration issues
Medline is recalling 2,740 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number: DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number: DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number: DYNDH1873; 5) BIOPSY SPECIALS PACK, Model
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1366-2026·2026-02-25
Medline Industries IV Administration and Extension Sets Recalled Due to Potential Leaks
Medline Industries, LP is recalling various IV administration and extension sets because male luer connectors may leak, crack, or break during use.
Product
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 SE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1409-2026·2026-02-25
Drape packs recalled over sterilization equipment calibration issues
Medline is recalling 240 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1424-2026·2026-02-25
Surgical gowns recalled over sterilization equipment calibration issues
Medline is recalling 70,376,042 units of surgical gowns because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
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) GOW
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1403-2026·2026-02-25
WMC ID packs recalled over sterilization equipment calibration issues
Medline is recalling 32 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1402-2026·2026-02-25
Driveline and central venous kits recalled over sterilization calibration issues
Medline is recalling 684 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1381-2026·2026-02-25
Thunderbeat inline grip devices removed after continued adverse event reports
Olympus is removing the Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip from the market, stating the action is due to continued reports of adverse events.
Product
Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1411-2026·2026-02-25
LVAD driveline trays recalled over sterilization equipment calibration issues
Medline is recalling 9,720 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1368-2026·2026-02-25
Infusion pumps recalled after being released without full testing
Baxter Healthcare is recalling 5 Spectrum IQ Infusion Pumps because they were released without full testing being performed, including occlusion alarm testing.
Product
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1405-2026·2026-02-25
General closure kits recalled over sterilization equipment calibration issues
Medline is recalling 108 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1399-2026·2026-02-25
Medline Medical Device Convenience Kits Recalled Due to Sterilization Calibration Issues
Medline Industries is recalling 154,427 medical device convenience kits due to calibration issues with sterilization equipment that could affect sterility assurance levels. No illnesses or injuries have been reported.
Product
Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER #5, Model Number: ACC010475; 4) DRAWER 1 NEURO CART, Model Number: ACC010542; 5) DRAWER 2 NEURO CART, Model Number: ACC01054
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1422-2026·2026-02-25
Arthroscopy kits recalled over sterilization equipment calibration issues
Medline is recalling 175 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501G; 3) ARTHROSCOPY PACK, Model Number: DYNJ32715F; 4) CHS ARTHROSCOPY PACK, Model Number: DYNJ50834C; 5) ARTHROSCOPY TRAY-LF, Model Number: DYNJ51069
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1369-2026·2026-02-25
Estrone RIA Diagnostic Kit Recall by Immunotech A.S.
Immunotech A.S. is recalling 160 Estrone RIA kits (REF: DSL8700) that may rarely give falsely high patient results, which could cause temporary injury with remote probability.
Product
Estrone RIA, REF: DSL8700
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1410-2026·2026-02-25
Admit kits recalled over sterilization equipment calibration issues
Medline is recalling 1,070 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1423-2026·2026-02-25
Surgical drapes recalled over sterilization equipment calibration issues
Medline is recalling 14,927,765 units of surgical drapes because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: DYNJP2411; 3) SHEET,DRAPE, 40X70,STERILE, Model Number: DYNJP2412; 4) DRAPE,MEDIUM,TAPE,40X70",ST,50/CS, Model Number: DYNJP2412T; 5) SHE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1427-2026·2026-02-25
Stryker MOLLI 2 System Recall: Marker Dislodgement Risk
Stryker is recalling the MOLLI 2 System due to magnetized surgical tools that may dislodge markers during target tissue removal procedures. The recall affects 5,864 units distributed worldwide.
Product
MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 008500241951
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1413-2026·2026-02-25
Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues
Medline Industries, LP is recalling various Medline Convenience Kits because equipment calibration issues may have impacted the sterility assurance level of the products.
Product
Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138; 4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142; 5) KIT NEURO FUS LUM P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1406-2026·2026-02-25
Choice drape packs recalled over sterilization equipment calibration issues
Medline is recalling 72 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1408-2026·2026-02-25
PPE kits recalled over sterilization equipment calibration issues
Medline is recalling 7,575 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1398-2026·2026-02-25
Lithotomy packs recalled over sterilization equipment calibration issues
Medline is recalling 808 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A;
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·26C002000·2026-02-25
Evenflo Recalls LiteMax Child Seats Due to Incorrect Spanish Manual
Evenflo is recalling LiteMax Factory Select child seats because the Spanish manual lists incorrect weight and height limits, which could lead to improper restraint.
Product
EQUIPMENT:OTHER:OWNERS/SERVICE/OTHER MANUAL recall
Category
Consumer Product
Distribution
Distributed nationwide