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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1776–1800 of 13384

HighFDA (Devices)·Z-0419-2026·2025-11-12
[pending] Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size
Pending LLM rewrite. Source: FDA_DEVICE Z-0419-2026.
Product
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-0432-2026·2025-11-12
[pending] Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm
Pending LLM rewrite. Source: FDA_DEVICE Z-0432-2026.
Product
Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic BiPolar Head, 42 mm OD, 22 mm Head; 3205.43.022 Klassic BiPolar Head, 43 mm OD, 22 mm Head; 3205.44.028 Klassic BiPolar Head, 44 mm OD, 28 mm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0435-2026·2025-11-12
[pending] 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex
Pending LLM rewrite. Source: FDA_DEVICE Z-0435-2026.
Product
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0422-2026·2025-11-12
[pending] MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr
Pending LLM rewrite. Source: FDA_DEVICE Z-0422-2026.
Product
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0438-2026·2025-11-12
[pending] bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
Pending LLM rewrite. Source: FDA_DEVICE Z-0438-2026.
Product
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0315-2026·2025-11-12
[pending] Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
Pending LLM rewrite. Source: FDA_DEVICE Z-0315-2026.
Product
Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0416-2026·2025-11-12
[pending] Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version:
Pending LLM rewrite. Source: FDA_DEVICE Z-0416-2026.
Product
Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology Information Management System Component: No The Sentinel Cardiology Information Management System is intended to connect to supported m
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0425-2026·2025-11-12
[pending] MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12
Pending LLM rewrite. Source: FDA_DEVICE Z-0425-2026.
Product
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0426-2026·2025-11-12
[pending] MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Componen
Pending LLM rewrite. Source: FDA_DEVICE Z-0426-2026.
Product
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0439-2026·2025-11-12
[pending] bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic
Pending LLM rewrite. Source: FDA_DEVICE Z-0439-2026.
Product
bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0433-2026·2025-11-12
[pending] Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software
Pending LLM rewrite. Source: FDA_DEVICE Z-0433-2026.
Product
Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The Intended Purpose of Leksell¿ Vantage" Stereotactic System is target localization and fixation of the patient head in a coordinate system in
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0374-2026·2025-11-12
[pending] CODMAN Disposable Perforator 9mm. Cranial Perforator.
Pending LLM rewrite. Source: FDA_DEVICE Z-0374-2026.
Product
CODMAN Disposable Perforator 9mm. Cranial Perforator.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0427-2026·2025-11-12
[pending] Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion p
Pending LLM rewrite. Source: FDA_DEVICE Z-0427-2026.
Product
Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set,
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-0429-2026·2025-11-12
[pending] Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer
Pending LLM rewrite. Source: FDA_DEVICE Z-0429-2026.
Product
Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0441-2026·2025-11-12
[pending] SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Pending LLM rewrite. Source: FDA_DEVICE Z-0441-2026.
Product
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0420-2026·2025-11-12
[pending] TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Numbe
Pending LLM rewrite. Source: FDA_DEVICE Z-0420-2026.
Product
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0370-2026·2025-11-05
[pending] BD Pyxis Pro MedStation Main, REF: 1155-00
Pending LLM rewrite. Source: FDA_DEVICE Z-0370-2026.
Product
BD Pyxis Pro MedStation Main, REF: 1155-00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0326-2026·2025-11-05
[pending] Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
Pending LLM rewrite. Source: FDA_DEVICE Z-0326-2026.
Product
Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0377-2026·2025-11-05
[pending] Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.
Pending LLM rewrite. Source: FDA_DEVICE Z-0377-2026.
Product
Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-0161-2026·2025-11-05
[pending] IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet
Pending LLM rewrite. Source: FDA_DEVICE Z-0161-2026.
Product
IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0396-2026·2025-11-05
[pending] Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;
Pending LLM rewrite. Source: FDA_DEVICE Z-0396-2026.
Product
Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0348-2026·2025-11-05
[pending] ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
Pending LLM rewrite. Source: FDA_DEVICE Z-0348-2026.
Product
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0393-2026·2025-11-05
[pending] Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;
Pending LLM rewrite. Source: FDA_DEVICE Z-0393-2026.
Product
Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0379-2026·2025-11-05
[pending] 9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;
Pending LLM rewrite. Source: FDA_DEVICE Z-0379-2026.
Product
9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0397-2026·2025-11-05
[pending] Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;
Pending LLM rewrite. Source: FDA_DEVICE Z-0397-2026.
Product
Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;
Category
Medical Device
Distribution
Distributed nationwide

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