Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

1701–1725 of 39948

HighFDA (Devices)·Z-1390-2026·2026-02-25
Medline Cardiac Surgical Convenience Kits Recalled Due to Sterility Calibration Issues
Medline Industries is recalling cardiac surgical convenience kits due to sterilization equipment calibration issues that could affect device sterility assurance levels.
Product
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; 3) OFF PUMP CABG CDS, Model Number: CDS840087AI; 4) OFF PUMP CABG CDS, Model Number: CDS840087AK; 5) OFF PUMP CABG CDS, Model Number: CDS840087AL; 6) OP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1419-2026·2026-02-25
Robotic surgery kits recalled over sterilization equipment calibration issues
Medline is recalling 7,725 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) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O; 4) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A; 5) KIT ROBOTICS UROLOGY PROSTA
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
HighFDA (Devices)·Z-1420-2026·2026-02-25
Medline Medical Device Kits Recalled Due to Sterilization Calibration Issues
Medline Industries is recalling 4,853 medical device kits due to potential sterility issues from equipment calibration problems during manufacturing.
Product
Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A; 3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DYKMBNDL159; 4) KIT OPHTHALMOLOGY CATARACT, Model Number: DYKMBNDL180; 5) K
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1372-2026·2026-02-25
Olympus Thunderbeat 5 mm 35 cm Surgical Device Recalled Due to Adverse Events
Olympus Corporation of the Americas is removing Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip Type S devices due to reports of adverse events.
Product
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1389-2026·2026-02-25
Arteriogram and catheter kits recalled over sterilization calibration issues
Medline is recalling 30,958 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) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4A; 4) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4B; 5) VEIN PROCEDURE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1380-2026·2026-02-25
Olympus Thunderbeat 5 mm 35 cm Inline Grip Medical Device Recall
Olympus Corporation of the Americas is recalling Olympus Thunderbeat 5 mm, 35 cm, Inline Grip devices due to reports of adverse events.
Product
Olympus Thunderbeat, 5 mm, 35 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-1386-2026·2026-02-25
Medline Convenience Kits and CPNB Setup Trays Recalled Due to Sterilization Calibration Issues
Medline Industries is recalling 779 units of convenience kits and setup trays due to potential sterility assurance issues from equipment calibration problems during manufacturing.
Product
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436B; 3) CPNB SETUP TRAY, Model Number: DYNJRA1979; 4) CPNB SETUP TRAY, Model Number: DYNJRA1979A; 5) CPNB SETUP TRAY, Model Number: SAMPA0108
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-1417-2026·2026-02-25
Medline C-Section Surgical Kits Recalled Over Sterilization Calibration
Medline is recalling 4,525 C-section convenience kits worldwide due to calibration issues with sterilization and packaging equipment that could affect sterility assurance.
Product
Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1421-2026·2026-02-25
Spinal and hip kits recalled over sterilization equipment calibration issues
Medline is recalling 117,907 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) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-
Category
Medical Device
Distribution
Distributed nationwide
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-1394-2026·2026-02-25
Cochlear and head kits recalled over sterilization equipment calibration issues
Medline is recalling 9,051 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) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KI
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-1391-2026·2026-02-25
PICC line and code cart kits recalled over sterilization calibration issues
Medline is recalling 5,346 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) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268B; 3) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268C; 4) TRAY 6 CENTRAL LINE A, Model Number: ACC010487; 5) PEDS PICC INSERTION TRAY
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-1376-2026·2026-02-25
Olympus Thunderbeat 5 mm Front-Actuated Grip Medical Device Recall
Olympus Corporation of the Americas is removing Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip devices due to reports of adverse events.
Product
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
Category
Medical Device
Distribution
Distributed nationwide
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-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-1363-2026·2026-02-25
MediHoney wound gel recalled over potential packaging failures
Integra LifeSciences is recalling 49,367 units of MediHoney Gel with Active Leptospermum Honey over potential packaging failures that could breach the sterile barrier.
Product
MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound healing and is indicated for light to moderately exuding wounds.
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-1425-2026·2026-02-25
Universal and shoulder packs recalled over sterilization calibration issues
Medline is recalling 193,157 units of surgical packs because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CSModel Number: DYNJP8401
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-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

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1701–1725 of 39948