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

1276–1300 of 13386

HighFDA (Devices)·Z-0960-2026·2025-12-24
[pending] Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
Pending LLM rewrite. Source: FDA_DEVICE Z-0960-2026.
Product
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-0957-2026·2025-12-24
[pending] BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Pending LLM rewrite. Source: FDA_DEVICE Z-0957-2026.
Product
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0940-2026·2025-12-24
[pending] MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
Pending LLM rewrite. Source: FDA_DEVICE Z-0940-2026.
Product
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0938-2026·2025-12-24
[pending] HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Pending LLM rewrite. Source: FDA_DEVICE Z-0938-2026.
Product
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0924-2026·2025-12-24
[pending] Zimmer Air Dermatome, Model/Catalog Number: 00880100100
Pending LLM rewrite. Source: FDA_DEVICE Z-0924-2026.
Product
Zimmer Air Dermatome, Model/Catalog Number: 00880100100
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0920-2026·2025-12-24
[pending] Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Dis
Pending LLM rewrite. Source: FDA_DEVICE Z-0920-2026.
Product
Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Audio Driver version 6.0.9484.1 HP Pro Mini 400 G9 Desktop PC with Realtek HD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0956-2026·2025-12-24
[pending] Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa
Pending LLM rewrite. Source: FDA_DEVICE Z-0956-2026.
Product
Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to address breathing and myofunctional disorders. Catalog Numbers:
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0961-2026·2025-12-24
[pending] Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Pending LLM rewrite. Source: FDA_DEVICE Z-0961-2026.
Product
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0928-2026·2025-12-24
[pending] Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.
Pending LLM rewrite. Source: FDA_DEVICE Z-0928-2026.
Product
Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0954-2026·2025-12-24
[pending] Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Numbe
Pending LLM rewrite. Source: FDA_DEVICE Z-0954-2026.
Product
Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied w
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0935-2026·2025-12-24
[pending] GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
Pending LLM rewrite. Source: FDA_DEVICE Z-0935-2026.
Product
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0927-2026·2025-12-24
[pending] Halyard, EP LAB PK. Catalog Number: ESJH009-03.
Pending LLM rewrite. Source: FDA_DEVICE Z-0927-2026.
Product
Halyard, EP LAB PK. Catalog Number: ESJH009-03.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0932-2026·2025-12-24
[pending] Cardiosave Rescue
Pending LLM rewrite. Source: FDA_DEVICE Z-0932-2026.
Product
Cardiosave Rescue
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0913-2026·2025-12-24
[pending] GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1,
Pending LLM rewrite. Source: FDA_DEVICE Z-0913-2026.
Product
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012-9620-000; Carestation 620 A1, REF 1012-9620-200; Carestation 620 A1, REF 1012-9620-202; Carestation 620 SE A1, REF 1012-9620
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0949-2026·2025-12-24
[pending] Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Imp
Pending LLM rewrite. Source: FDA_DEVICE Z-0949-2026.
Product
Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B490502103 502-104 - Calf Implant style 1 size 4 UDI-DI code: B490502104 502-105 - Calf Implant style 1 size 5 UDI-DI code: B490502105
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-0929-2026·2025-12-24
[pending] Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.
Pending LLM rewrite. Source: FDA_DEVICE Z-0929-2026.
Product
Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0930-2026·2025-12-24
[pending] Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.
Pending LLM rewrite. Source: FDA_DEVICE Z-0930-2026.
Product
Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0947-2026·2025-12-24
[pending] Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar
Pending LLM rewrite. Source: FDA_DEVICE Z-0947-2026.
Product
Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 right UDI-DI code: B4904012026
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-0931-2026·2025-12-24
[pending] Cardiosave Hybrid
Pending LLM rewrite. Source: FDA_DEVICE Z-0931-2026.
Product
Cardiosave Hybrid
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0955-2026·2025-12-24
[pending] Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Numbe
Pending LLM rewrite. Source: FDA_DEVICE Z-0955-2026.
Product
Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied w
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0885-2026·2025-12-24
[pending] Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration o
Pending LLM rewrite. Source: FDA_DEVICE Z-0885-2026.
Product
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-0936-2026·2025-12-24
[pending] 5008X CAREsystem +CLiC +CDX;
Pending LLM rewrite. Source: FDA_DEVICE Z-0936-2026.
Product
5008X CAREsystem +CLiC +CDX;
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0951-2026·2025-12-24
[pending] Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Nu
Pending LLM rewrite. Source: FDA_DEVICE Z-0951-2026.
Product
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplie
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0942-2026·2025-12-24
[pending] 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP
Pending LLM rewrite. Source: FDA_DEVICE Z-0942-2026.
Product
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0952-2026·2025-12-24
[pending] Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Numbe
Pending LLM rewrite. Source: FDA_DEVICE Z-0952-2026.
Product
Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied w
Category
Medical Device
Distribution
12 states

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1276–1300 of 13386