Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

451–475 of 50462

HighFDA (Food)·H-1194-2026·2026-08-12
Hondashi Seasoning Recalled Due to Unlabeled Fish Allergen
Pack'n Fresh LLC is recalling various lots of Hondashi 0.25oz seasoning because the product contains fish that is not listed in the ingredients statement.
Product
"***Hondashi 0.25oz***" seasoning packed in silver plastic/metallic pouch, pouches packed in brown paperboard cartons (600 packets/carton), Carton label reads in part as "***Hondashi 0.25oz*600bags/ctn, Ingredients: salt, sodium glutamate, bonito, cornstarch, maltodextrin…
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-2878-2026·2026-08-12
GE Healthcare Portrait Core Services Software Recall Due to Software Vulnerability
GE Medical Systems Information Technologies Inc is recalling GE Healthcare Portrait Core Services SW V 1.2.0 (REF 5700592) patient monitoring systems due to a software vulnerability.
Product
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·26E055000·2026-08-12
Mack Recalls Grote Replacement Marker Lights for Visibility Failure
Mack Trucks is recalling certain Grote replacement marker lights that may fail to illuminate, reducing vehicle visibility and increasing crash risk.
Product
GROTE — GROTE CLEARANCE/MARKER LAMP
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2858-2026·2026-08-12
Medical Action Industries Recalls Dialysis Change Tray Kits Due to Seal Defect
Medical Action Industries is recalling 3,740 Dialysis Change Tray Clear Sequence kits because the needle-free access device may have an improper seal.
Product
Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2874-2026·2026-08-12
Merge PACS Medical Imaging Workstation Recalled Due to Patient Data Display Error
Merge Healthcare is recalling 53 Merge PACS medical imaging workstations due to a software issue where thumbnails from one patient's study may incorrectly display when viewing a different patient's study, potentially compromising patient confidentiality.
Product
Merge PACS, medical imaging diagnostic workstation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2836-2026·2026-08-12
FORWARD Oral Airway Kit Recall for Potential Airway Obstruction
Integrated Medcraft LLC recalls FORWARD Oral Airway Kits due to potential occlusion of the airway tip, which could impede breathing in medical settings.
Product
FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2902-2026·2026-08-12
Peripheral Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
Tissium SA is relabeling COAPTIUM CONNECT nerve repair devices because the 36-month shelf life is not supported by real-time data. The revised shelf life is 26 months.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2899-2026·2026-08-12
GEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
Instrumentation Laboratory is recalling specific GEM Premier 7000 with iQM3 PAK lots because the lysing bag solution concentration does not meet manufacturing specifications, potentially delaying medical management.
Product
GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2901-2026·2026-08-12
COAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
Tissium SA is relabeling COAPTIUM Connect nerve repair devices to reduce the shelf life from 36 to 26 months because the original duration was not supported by real-time data.
Product
Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2885-2026·2026-08-12
U2 Total Knee System Femoral Valgus Adaptor Recall
United Orthopedic Corp. is recalling its U2 Total Knee System femoral valgus adaptors due to a manufacturing defect that prevents proper assembly of the stem component during surgery.
Product
Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2844-2026·2026-08-12
Quantum Rehab R-TRAK Powered Wheelchair Controller Recalled Due to Software Issue
Pride Mobility Products Corp. is recalling Quantum Rehab R-TRAK powered wheelchairs due to a software issue that can cause unexpected braking or system crashes.
Product
Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2893-2026·2026-08-12
Philips Fluoroscopy System Recall Over Hard Disk Drive Issue
Philips is recalling 257 Allura/Centron interventional fluoroscopic X-ray systems due to potential loss of imaging, motorized movement, or data caused by unauthorized hard disk drives.
Product
Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2848-2026·2026-08-12
Quantum Rehab Q6 Edge 2.0 Wheelchair Recall Due to Safety Risks
The FDA is recalling the Quantum Rehab Q6 Edge 2.0 powered wheelchair because its controller may cause unexpected braking or system crashes that could lead to falls and injuries.
Product
Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Model/Catalog Number: Q6 Edge 2.0 (ilevel) Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2894-2026·2026-08-12
5-PLASMA Bivalirudin AMR Verification Kit Recalled Due to Stability Issues
Aniara Diagnostica LLC recalls its 5-PLASMA Bivalirudin AMR Verification Kit due to stability issues causing degradation of measurable bivalirudin in controls, calibrators, and linearity values. FDA Class II recall.
Product
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2903-2026·2026-08-12
Tissium Peripheral Nerve Repair Device Shelf Life Recall
Tissium SA is recalling the COAPTIUM CONNECT peripheral nerve repair device due to an unsubstantiated 36-month shelf life; devices will be relabeled to a validated 26-month shelf life.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·26E054000·2026-08-12
Volvo Trucks Recalls Grote Replacement Marker Lights for Visibility Issues
Volvo Trucks is recalling certain Grote replacement marker lights that may fail to illuminate, reducing vehicle visibility and increasing crash risk.
Product
GROTE — GROTE CLEARANCE/MARKER LAMP
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2868-2026·2026-08-12
Intramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
Biomet, Inc. is recalling certain Intramedullary Bone Saw Blade Assemblies because an exposed saw blade may have damaged the sterile barrier packaging.
Product
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2865-2026·2026-08-12
Stryker Single Spike Tube Set Recalled for Leaking During Use
Stryker is recalling 11,857 Single Spike Tube Sets due to reports of leaking from the handpiece during use.
Product
STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2863-2026·2026-08-12
Stryker Ahto Tube Set Recalled for Handpiece Leaking During Use
Stryker is recalling 41,052 Ahto Tube Sets worldwide due to reports of handpiece leaking during use.
Product
STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2869-2026·2026-08-12
Intramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
Biomet, Inc. is recalling various sizes of Intramedullary Bone Saw Blade Assemblies because an exposed saw blade may have damaged the sterile barrier packaging.
Product
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2877-2026·2026-08-12
FilmArray NGDS Warrior Panel Diagnostic Test Recalled Due to Strain Mismatch
Biofire Defense is recalling FilmArray NGDS Warrior Panel kits because the test may not correctly identify certain outbreak strains due to mismatches with the reference strain used during development.
Product
FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system. The FilmArray NGDS Warrior Panel detects…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2907-2026·2026-08-12
Coaptium Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
Tissium SA is relabeling Coaptium Connect nerve repair devices because the current 36-month shelf life is not supported by real-time data. The shelf life is being reduced to 26 months.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2839-2026·2026-08-12
Biopsy Forceps Recall: Sterile Packaging Breach Risk
Boston Scientific is recalling Radial Jaw 4 Large Capacity Biopsy Forceps due to a potential breach in the sterile barrier of device packaging, which could compromise sterility.
Product
Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240cm Box 40; Outer Box UPN: M00513322; Inner Box UPN: M00513320. 3. Radial…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2861-2026·2026-08-12
DASH Rapid PCR Instrument Recalled Due to Software Issue Causing False Co-infection Results
Nuclein LLC is recalling the DASH Rapid PCR Instrument (Model SG-0002) because a software issue may result in false co-infection readings.
Product
Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Product Description: The DASH¿ Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2849-2026·2026-08-12
Quantum Rehab Q6 Edge 3 Powered Wheelchair Controller Recalled for Unexpected Braking
Pride Mobility Products Corp. is recalling the Quantum Rehab Q6 Edge 3 powered wheelchair controller due to a software issue that can cause unexpected braking and potential injury.
Product
Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 Edge 3 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide