The Recall Desk

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.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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1626–1650 of 114837

  • 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
  • HighFDA (Devices)·Z-2847-2026·2026-08-12

    Powered Wheelchair Controller Software May Cause Unexpected Brake Stop

    Pride Mobility is recalling 1,102 Quantum 1450 powered wheelchairs with controller software version 2.0.11 because reminder pop-ups can trigger an unexpected park brake stop while driving, risking falls or injury.

    Product
    Brand Name: Quantum Rehab Product Name: Quantum 1450 Model/Catalog Number: Quantum 1450 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-2886-2026·2026-08-12

    United Orthopedic Corp. Recalls Femoral Valgus Offset Adaptors for U2 Total Knee System

    United Orthopedic Corp. is recalling specific femoral valgus offset adaptors used in the U2 Total Knee System due to a manufacturing defect in a component screw.

    Product
    Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2846-2026·2026-08-12

    Quantum Rehab Q6 Edge 2.0 Power Wheelchair Recall

    Pride Mobility is recalling 1,102 Q6 Edge 2.0 power wheelchairs due to a software issue that may cause unexpected braking or control system crashes during use.

    Product
    Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q6 Edge 2.0 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-2906-2026·2026-08-12

    COAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling

    TISSIUM SA recalls COAPTIUM CONNECT nerve repair devices due to unvalidated 36-month shelf life labeling. Revised 26-month label will be applied. Device breakage beyond validated shelf life may require revision surgery.

    Product
    Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO4010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2887-2026·2026-08-12

    HardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges

    Hardy Diagnostics is recalling HardyDisk AST Cefiderocol 30µg (Lot 543461) because incorrect cartridges may cause inaccurate susceptibility testing results.

    Product
    HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales, Pseudomonas aeruginosa, Acinetobacter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2898-2026·2026-08-12

    United Orthopedic Recalls U2 Total Knee System Femoral Offset Bushings

    United Orthopedic Corp. is recalling U2 Total Knee System femoral offset bushings due to incorrect engraved numbering that could cause incorrect implant orientation.

    Product
    Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2851-2026·2026-08-12

    Quantum 4Front 2HD Powered Wheelchair Recall Due to Potential Safety Issues

    A recall has been issued for the Quantum 4Front 2HD powered wheelchair because its controller software may cause unexpected braking or system failure that could lead to falls or injury.

    Product
    Brand Name: Quantum Rehab Product Name: Quantum 4Front 2HD Model/Catalog Number: Quantum 4Front 2HD 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-2866-2026·2026-08-12

    Stryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use

    Stryker is recalling Strykeflow Suction/Irrigator PS devices due to reports of leaking from the handpiece during use.

    Product
    STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2853-2026·2026-08-12

    Quantum Rival Powered Wheelchair Controller Recall for Brake Stop Hazard

    Pride Mobility Products Corp. is recalling 1,102 Quantum Rival powered wheelchair controllers due to a software issue that can cause unexpected brake stops while driving, potentially resulting in falls or injuries.

    Product
    Brand Name: Quantum Rehab Product Name: Quantum Rival Model/Catalog Number: Quantum Rival 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
  • ModerateFDA (Devices)·Z-2908-2026·2026-08-12

    COAPTIUM CONNECT medical device shelf life recalibration recall

    TISSIUM SA is recalling COAPTIUM CONNECT devices because their original 36-month shelf life was not supported by real-time data, requiring relabeling to a 26-month shelf life to prevent potential device failure during surgery.

    Product
    Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO6010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2882-2026·2026-08-12

    Happiest Baby Recalls Pre-Loved SNOO Smart Sleeper Bassinets

    Happiest Baby, Inc is recalling 4 refurbished SNOO Smart Sleeper bassinets (Model S1000) that failed to meet quality standards before distribution. The recall is being reported retroactively.

    Product
    Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2910-2026·2026-08-12

    Blom-Singer Voice Prosthesis Recalled Due to Incorrect Labeling

    Freudenberg Medical recalls 40 Blom-Singer Classic Indwelling Voice Prostheses due to labeling errors that could cause confusion about product contents.

    Product
    Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0733-2026·2026-08-12

    Dicyclomine Hydrochloride Capsules Recalled for Empty Capsules

    Aurobindo Pharma is recalling dicyclomine hydrochloride capsules, 10mg, due to reports of empty capsules found in the product.

    Product
    DICYCLOMINE HYDROCHLORIDE — DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2895-2026·2026-08-12

    Aniara 5-PLASMA Bivalirudin Calibrator Recalled for Stability Issues

    Aniara Diagnostica LLC is recalling 7 units of 5-PLASMA Bivalirudin Calibrator due to stability issues that cause degradation of measurable bivalirudin.

    Product
    5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-1236-2026·2026-08-12

    Campo Rico Foods Recalls Frozen Shrimp Due to Nitrofurans

    Campo Rico Foods LLC is recalling 11 cases of Kanni Delight frozen shrimp because nitrofurans were detected in the product.

    Product
    Kanni Delight 31/40 Fresh Frozen Vannamei White Shrimp IQF, Raw Peeled & Deveined Tail Off, Gross Weight: 5 lb., packaged in polyethylene bags, packed 6 bags per case, Product of India, Farm Raised, for food service only
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2871-2026·2026-08-12

    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: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2896-2026·2026-08-12

    5-PLASMA Bivalirudin Control Model 5D-44905 Recalled Due to Stability Issues

    Aniara Diagnostica LLC is recalling 5-PLASMA Bivalirudin Control (Model 5D-44905) due to stability issues that may cause degradation of measurable bivalirudin.

    Product
    5-PLASMA Bivalirudin Control, Model Number 5D-44905
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-1193-2026·2026-08-12

    Flexible food pouches may release thin plastic strips into food

    Cheer Pack is recalling certain flexible food pouches because they may release thin plastic strips into food products.

    Product
    Flexible food pouch (3-layer foil, spouted, #CP6088), manufactured for packaging Pumpkin Tree Peter Rabbit Organics Banana & Strawberry, 4 oz food puree, UPC 815367010780.
    Category
    Consumer Product
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2881-2026·2026-08-12

    Siemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2

    Siemens Healthcare Diagnostics is recalling Lot U2 of its Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls due to an out-of-specification sodium azide concentration. The recall affects 494 units in the US and 114 units overseas, distributed nationwide and internationally.

    Product
    Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2838-2026·2026-08-12

    Boston Scientific Radial Jaw 4 Biopsy Forceps Recalled Due to Sterile Barrier Breach Risk

    Boston Scientific Corporation is recalling specific Radial Jaw 4 Standard Capacity Biopsy Forceps because there is a potential for a breach in the sterile barrier of the device packaging.

    Product
    Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SC 240cm Box 40; Outer Box UPN: M00513402; Inner Box UPN: M00513400. 3.…
    Category
    Medical Device
    Distribution
    Distributed nationwide