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.

Agency

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1626–1650 of 13384

HighFDA (Devices)·Z-0585-2026·2025-12-03
[pending] 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
Pending LLM rewrite. Source: FDA_DEVICE Z-0585-2026.
Product
1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0628-2026·2025-12-03
[pending] Extension Set utilized in gravity IV administration sets and pump administration sets utilized with
Pending LLM rewrite. Source: FDA_DEVICE Z-0628-2026.
Product
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. ET08US EXTENSION SET W/ULTRA Y SITE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0645-2026·2025-12-03
[pending] IV Administration Set utilized in gravity IV administration sets and pump administration sets utiliz
Pending LLM rewrite. Source: FDA_DEVICE Z-0645-2026.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET 15DR 5CARESITE 1 ULR
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0660-2026·2025-12-03
[pending] IV Administration Set utilized in gravity IV administration sets and pump administration sets utiliz
Pending LLM rewrite. Source: FDA_DEVICE Z-0660-2026.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET,2 CARESITE, TR
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0708-2026·2025-12-03
[pending] Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BB
Pending LLM rewrite. Source: FDA_DEVICE Z-0708-2026.
Product
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK PUMP SET 3 CARESITE LADS 133
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0519-2026·2025-11-26
[pending] MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD,
Pending LLM rewrite. Source: FDA_DEVICE Z-0519-2026.
Product
MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD, REF CDS984267J; 3) PLASTIC PACK, REF DYNJ00264M; 4) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947L; 5) BREAST ABDOMINOPLASTY MB PK-LF, REF DYNJ0428947M; 6) AUGMENTATION #
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0564-2026·2025-11-26
[pending] SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 0
Pending LLM rewrite. Source: FDA_DEVICE Z-0564-2026.
Product
SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0545-2026·2025-11-26
[pending] SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator and Serum Separat
Pending LLM rewrite. Source: FDA_DEVICE Z-0545-2026.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7120 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the f
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0544-2026·2025-11-26
[pending] SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium Heparin; Green Model/Ca
Pending LLM rewrite. Source: FDA_DEVICE Z-0544-2026.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 6101 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0556-2026·2025-11-26
[pending] SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings Model/Catalog Number:
Pending LLM rewrite. Source: FDA_DEVICE Z-0556-2026.
Product
SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0525-2026·2025-11-26
[pending] MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O
Pending LLM rewrite. Source: FDA_DEVICE Z-0525-2026.
Product
MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0547-2026·2025-11-26
[pending] SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Red Model/Catal
Pending LLM rewrite. Source: FDA_DEVICE Z-0547-2026.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7150 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0542-2026·2025-11-26
[pending] REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with
Pending LLM rewrite. Source: FDA_DEVICE Z-0542-2026.
Product
REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0529-2026·2025-11-26
[pending] MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) MINOR EYE TRAY #
Pending LLM rewrite. Source: FDA_DEVICE Z-0529-2026.
Product
MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) MINOR EYE TRAY #81, REF DYNJ27466T.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0562-2026·2025-11-26
[pending] SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Sodium Heparin Model/Catalog N
Pending LLM rewrite. Source: FDA_DEVICE Z-0562-2026.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0009 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0514-2026·2025-11-26
[pending] MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP PACK, REF D
Pending LLM rewrite. Source: FDA_DEVICE Z-0514-2026.
Product
MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP PACK, REF DYNJ68213C.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0528-2026·2025-11-26
[pending] MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F
Pending LLM rewrite. Source: FDA_DEVICE Z-0528-2026.
Product
MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0430-2026·2025-11-26
[pending] BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY O
Pending LLM rewrite. Source: FDA_DEVICE Z-0430-2026.
Product
BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Clean
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0506-2026·2025-11-26
[pending] Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 1065
Pending LLM rewrite. Source: FDA_DEVICE Z-0506-2026.
Product
Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531LF2, HeartMate 3 Low Flow 2.0 Controller Software Version: N/A Product Description: The HeartMate
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0558-2026·2025-11-26
[pending] SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced Heparin, Model/Catal
Pending LLM rewrite. Source: FDA_DEVICE Z-0558-2026.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced Heparin, Model/Catalog Number: 06 0187 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0536-2026·2025-11-26
[pending] Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 3
Pending LLM rewrite. Source: FDA_DEVICE Z-0536-2026.
Product
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0553-2026·2025-11-26
[pending] SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fluoride; Gray Model/Cat
Pending LLM rewrite. Source: FDA_DEVICE Z-0553-2026.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0568-2026·2025-11-26
[pending] Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test A
Pending LLM rewrite. Source: FDA_DEVICE Z-0568-2026.
Product
Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0550-2026·2025-11-26
[pending] SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Separ
Pending LLM rewrite. Source: FDA_DEVICE Z-0550-2026.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7221 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from t
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0539-2026·2025-11-26
[pending] Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Pending LLM rewrite. Source: FDA_DEVICE Z-0539-2026.
Product
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Category
Medical Device
Distribution
Distributed nationwide

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1626–1650 of 13384