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

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

1676–1700 of 13384

HighFDA (Devices)·Z-0511-2026·2025-11-26
[pending] MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M
Pending LLM rewrite. Source: FDA_DEVICE Z-0511-2026.
Product
MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0517-2026·2025-11-26
[pending] MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR LAPAROTO
Pending LLM rewrite. Source: FDA_DEVICE Z-0517-2026.
Product
MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR LAPAROTOMY CDS, REF CDS860015X; 3) MINOR LAPAROTOMY CDS, REF CDS860016R; 4) MINOR LAPAROTOMY CDS, REF CDS860016S; 5) LAPAROTOMY CDS #31-RF, REF CDS860062S; 6) LAPAROSCOPY CDS, REF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0546-2026·2025-11-26
[pending] SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator and Serum Separat
Pending LLM rewrite. Source: FDA_DEVICE Z-0546-2026.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7121 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-0563-2026·2025-11-26
[pending] SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Balanced Heparin Model/Catalog
Pending LLM rewrite. Source: FDA_DEVICE Z-0563-2026.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Balanced Heparin Model/Catalog Number: 06 0185 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0513-2026·2025-11-26
[pending] MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTE
Pending LLM rewrite. Source: FDA_DEVICE Z-0513-2026.
Product
MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 3) PERIPHERAL VASCULAR CDS, REF CDS983723J; 4) ACH OPEN HEART, REF CDS983773J; 5) VASCULAR, REF CDS984255K; 6) OPEN HEART CHILDRENS PACK-LF,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0530-2026·2025-11-26
[pending] MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC B
Pending LLM rewrite. Source: FDA_DEVICE Z-0530-2026.
Product
MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC BACK CDS, REF CDS780147N; 3) INSTRUMENTED BACK CDS, REF CDS780148R; 4) NEURO-LAMI CDS, REF CDS780208I; 5) TOTAL HIP, REF CDS920027Y; 6) TOTAL KNEE, REF CDS940072Y; 7) TOTA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0543-2026·2025-11-26
[pending] MONARCH Bronchoscope. Model Number: MBR-000211-B
Pending LLM rewrite. Source: FDA_DEVICE Z-0543-2026.
Product
MONARCH Bronchoscope. Model Number: MBR-000211-B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0505-2026·2025-11-26
[pending] Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog
Pending LLM rewrite. Source: FDA_DEVICE Z-0505-2026.
Product
Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 106524INT, HeartMate 3 LVAD KIT, OUS; 106524 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist Syste
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0560-2026·2025-11-26
[pending] SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Sodium Heparin Model/Catalog N
Pending LLM rewrite. Source: FDA_DEVICE Z-0560-2026.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0005 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0537-2026·2025-11-26
[pending] Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 30
Pending LLM rewrite. Source: FDA_DEVICE Z-0537-2026.
Product
Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a component
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0521-2026·2025-11-26
[pending] MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027W; 2) GENERAL MAJOR C
Pending LLM rewrite. Source: FDA_DEVICE Z-0521-2026.
Product
MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027W; 2) GENERAL MAJOR CDS, REF CDS980245X; 3) BASIC GENERAL CDS, REF CDS980566F; 4) TOTAL KNEE CDS, REF CDS982823R; 5) BASIC CDS, REF CDS982936U; 6) UPPER EXTREMITY CDS, REF CDS983907M; 7) MAJO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0503-2026·2025-11-26
[pending] MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Versi
Pending LLM rewrite. Source: FDA_DEVICE Z-0503-2026.
Product
MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0520-2026·2025-11-26
[pending] MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ37698L; 2) BASIN PACK,
Pending LLM rewrite. Source: FDA_DEVICE Z-0520-2026.
Product
MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ37698L; 2) BASIN PACK, REF DYNJ50123D; 3) MAJOR BASIN PACK, REF DYNJ59816A; 4) OSC BASIN PACK, REF DYNJ68217A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0510-2026·2025-11-26
[pending] MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.
Pending LLM rewrite. Source: FDA_DEVICE Z-0510-2026.
Product
MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0574-2026·2025-11-26
[pending] Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC
Pending LLM rewrite. Source: FDA_DEVICE Z-0574-2026.
Product
Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR US
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0567-2026·2025-11-26
[pending] SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004
Pending LLM rewrite. Source: FDA_DEVICE Z-0567-2026.
Product
SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0515-2026·2025-11-26
[pending] MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BIOPSY BREA
Pending LLM rewrite. Source: FDA_DEVICE Z-0515-2026.
Product
MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BIOPSY BREAST PACK, REF DYNJ65361A; 3) BREAST BIOPSY/MASTECTOMY, REF DYNJ908839A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0549-2026·2025-11-26
[pending] AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin and Plasma Separa
Pending LLM rewrite. Source: FDA_DEVICE Z-0549-2026.
Product
AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7220 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from th
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0533-2026·2025-11-26
[pending] PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-0
Pending LLM rewrite. Source: FDA_DEVICE Z-0533-2026.
Product
PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-0518-2026·2025-11-26
[pending] MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
Pending LLM rewrite. Source: FDA_DEVICE Z-0518-2026.
Product
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0551-2026·2025-11-26
[pending] SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin; Green Model/Ca
Pending LLM rewrite. Source: FDA_DEVICE Z-0551-2026.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7250 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-0557-2026·2025-11-26
[pending] SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 0186
Pending LLM rewrite. Source: FDA_DEVICE Z-0557-2026.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 0186 Product Description: A clear, plastic capillary blood collection tube coated with Heparin
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0527-2026·2025-11-26
[pending] MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 2) MAJ
Pending LLM rewrite. Source: FDA_DEVICE Z-0527-2026.
Product
MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 2) MAJOR LITHOTOMY PACK-LF, REF DYNJ0425778O; 3) MINOR VAGINAL #76-RF, REF DYNJ27434R; 4) ABDOMINAL HYST PACK, REF DYNJ44848M; 5) DA VINCI HYSTERECTOMY, REF DYNJ44863Q; 6) VAGINA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0516-2026·2025-11-26
[pending] MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2) HEAD AND NECK, REF CD
Pending LLM rewrite. Source: FDA_DEVICE Z-0516-2026.
Product
MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2) HEAD AND NECK, REF CDS984259P; 3) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F; 4) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I; 5) THORACOTOMY HARPER PACK-LF, REF DYNJ0161795F; 6) MAJOR ENT MZ PAC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0522-2026·2025-11-26
[pending] MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; 2) ACDF CDS, REF CDS9
Pending LLM rewrite. Source: FDA_DEVICE Z-0522-2026.
Product
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; 2) ACDF CDS, REF CDS941061M; 3) NEURO PACK-LF, REF DYNJ0038440C; 4) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S; 5) NEURO-ORTHO EXTRAS, REF DYNJ44882M; 6) LAMINECTOMY, REF DYNJ903870F.
Category
Medical Device
Distribution
Distributed nationwide

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1676–1700 of 13384