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

1301–1325 of 13386

HighFDA (Devices)·Z-0944-2026·2025-12-24
[pending] Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbe
Pending LLM rewrite. Source: FDA_DEVICE Z-0944-2026.
Product
Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 600-602 - Silicone Carving Implant Style 6 Size 2 UDI-DI code: B490600602 600-601-9 - Silicone Carvi
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-0914-2026·2025-12-24
[pending] GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1,
Pending LLM rewrite. Source: FDA_DEVICE Z-0914-2026.
Product
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012-9750-002; Carestation 750c A1, REF 1012-9755-000; Products for which affected PMB can be used as a spare part: Carestatio
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0959-2026·2025-12-24
[pending] Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
Pending LLM rewrite. Source: FDA_DEVICE Z-0959-2026.
Product
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-0925-2026·2025-12-24
[pending] Zimmer Dermatome AN, Model/Catalog Number: 88710100
Pending LLM rewrite. Source: FDA_DEVICE Z-0925-2026.
Product
Zimmer Dermatome AN, Model/Catalog Number: 88710100
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0946-2026·2025-12-24
[pending] Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Imp
Pending LLM rewrite. Source: FDA_DEVICE Z-0946-2026.
Product
Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B490400101 400-0103 Chin Implant style 1 size 3 UDI-DI code: B490400103 400-0104 Chin Implant style 1 size 4 UDI-DI code: B490400104 40
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-0950-2026·2025-12-24
[pending] Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Numbe
Pending LLM rewrite. Source: FDA_DEVICE Z-0950-2026.
Product
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0937-2026·2025-12-24
[pending] Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF
Pending LLM rewrite. Source: FDA_DEVICE Z-0937-2026.
Product
Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-400135; Navigation, 4.0mm Drill, REF: PC2-400140; Navigation, 4.5mm Drill, PC2-4001
Category
Medical Device
Distribution
24 states
HighFDA (Devices)·Z-0958-2026·2025-12-24
[pending] InPen App, Model/CFN Number: MMT-8061 (Android Users)
Pending LLM rewrite. Source: FDA_DEVICE Z-0958-2026.
Product
InPen App, Model/CFN Number: MMT-8061 (Android Users)
Category
Medical Device
Distribution
50 states
HighFDA (Devices)·Z-0921-2026·2025-12-24
[pending] SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000
Pending LLM rewrite. Source: FDA_DEVICE Z-0921-2026.
Product
SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0943-2026·2025-12-24
[pending] 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
Pending LLM rewrite. Source: FDA_DEVICE Z-0943-2026.
Product
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0922-2026·2025-12-24
[pending] FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048
Pending LLM rewrite. Source: FDA_DEVICE Z-0922-2026.
Product
FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0941-2026·2025-12-24
[pending] Intelerad InteleShare software, with ProViewer component
Pending LLM rewrite. Source: FDA_DEVICE Z-0941-2026.
Product
Intelerad InteleShare software, with ProViewer component
Category
Medical Device
Distribution
45 states
HighFDA (Devices)·Z-0948-2026·2025-12-24
[pending] Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5
Pending LLM rewrite. Source: FDA_DEVICE Z-0948-2026.
Product
Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UDI-DI code: B4905001065 500-106-6 Pectoral Implant style 1 size 6 right UDI-DI code: B4905001066 500-200-5 Pectoral Implant style 2 si
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-0945-2026·2025-12-24
[pending] Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - G
Pending LLM rewrite. Source: FDA_DEVICE Z-0945-2026.
Product
Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style 1 size 1 UDI-DI code: B490501101 501-103 - Gluteal Implant style 1 size 3 UDI-DI code: B490501103 501-101 UDI-DI code: B490501101 501-103 - Gluteal
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-0926-2026·2025-12-24
[pending] Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.
Pending LLM rewrite. Source: FDA_DEVICE Z-0926-2026.
Product
Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0915-2026·2025-12-24
[pending] GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU
Pending LLM rewrite. Source: FDA_DEVICE Z-0915-2026.
Product
GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0953-2026·2025-12-24
[pending] Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Nu
Pending LLM rewrite. Source: FDA_DEVICE Z-0953-2026.
Product
Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-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-0904-2026·2025-12-17
[pending] Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS
Pending LLM rewrite. Source: FDA_DEVICE Z-0904-2026.
Product
Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0917-2026·2025-12-17
[pending] Cardiosave Rescue. Intra-Aortic Balloon Pump system.
Pending LLM rewrite. Source: FDA_DEVICE Z-0917-2026.
Product
Cardiosave Rescue. Intra-Aortic Balloon Pump system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0909-2026·2025-12-17
[pending] AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 705
Pending LLM rewrite. Source: FDA_DEVICE Z-0909-2026.
Product
AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0910-2026·2025-12-17
[pending] AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 70
Pending LLM rewrite. Source: FDA_DEVICE Z-0910-2026.
Product
AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0907-2026·2025-12-17
[pending] BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
Pending LLM rewrite. Source: FDA_DEVICE Z-0907-2026.
Product
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0895-2026·2025-12-17
[pending] Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38
Pending LLM rewrite. Source: FDA_DEVICE Z-0895-2026.
Product
Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 6H; 38-2007SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 7H; 38-2008SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 8H; 38-2009SP F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0905-2026·2025-12-17
[pending] Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
Pending LLM rewrite. Source: FDA_DEVICE Z-0905-2026.
Product
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0889-2026·2025-12-17
[pending] Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality co
Pending LLM rewrite. Source: FDA_DEVICE Z-0889-2026.
Product
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901
Category
Medical Device
Distribution
Distributed nationwide

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1301–1325 of 13386