PlainRecalls

2026 Recall Year Insight

Federal agencies issued 3,961 product recalls indexed by PlainRecalls in calendar year 2026. That represents about 3.79% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 10.9 recalls per day across the FDA, CPSC, USDA FSIS, and NHTSA combined. Year-level views are the cleanest way to see macro patterns: volume spikes often correlate with new regulatory priorities (e.g., infant-sleep products after 2021, lithium-ion batteries after 2022), supply-chain contamination events, or changes in agency enforcement intensity, while quiet years can reflect either genuine product-safety improvements or reduced agency staffing and reporting lag. With 80 pages at 50 recalls each, browsing this year end-to-end gives a statistically representative sample of what the federal recall pipeline looked like in 2026.

On this page of 50 records, severity classification shows 3 critical, 46 moderate, and 1 lower-severity recalls. The page references 27 distinct recalling firms operating in 1 distinct product categories, with 45 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (50), which matters because each agency's recall authority, hazard framing, and remedy mechanism differ, an FDA food recall, a CPSC consumer-product recall, and a NHTSA vehicle recall are legally distinct instruments even when the underlying hazard language sounds similar. Reviewing the dominant agency for a given year is one of the fastest ways to understand where federal attention was concentrated.

Year-indexed browsing serves three practical purposes: historical research (tracking how a hazard class evolved over time), consumer action (finding whether a product purchased in 2026 was later recalled), and journalistic or regulatory context (understanding what the enforcement landscape looked like in a given period). Every record on this page links to a full detail view with the hazard, remedy, distribution, and agency-assigned recall number, always use that recall number to verify current status directly with the issuing agency before acting on time-sensitive remedies, because agencies amend, terminate, and expand recalls in the months and years after initial publication. Data on this page reflects federal agency public filings; the agency's live record remains authoritative for legal, medical, or safety decisions. Verify with FDA openFDA, CPSC, USDA FSIS, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Moderate Aug 12, 2026

Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000

Happiest Baby, Inc

FDA Devices Moderate Aug 12, 2026

Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1, 2.33.3 and 2.34.2 Product Description: WASPLab is an automated device intended to be used for the incubation and the digital imaging of agar culture plates streaked with microbiological specimens derived by the human body for microbiological investigations. WebApp software is the user interface of WASPLab device.

Copan WASP

FDA Devices Moderate Aug 12, 2026

5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905

Aniara Diagnostica LLC

FDA Devices Moderate Aug 12, 2026

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

TISSIUM SA

FDA Devices Moderate Aug 12, 2026

GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A

Instrumentation Laboratory

FDA Devices Moderate Aug 12, 2026

STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640

Stryker Corporation

FDA Devices Moderate Aug 12, 2026

Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A

United Orthopedic Corp.

FDA Devices Moderate Aug 12, 2026

Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System

Innovasis, Inc

FDA Devices Moderate Aug 12, 2026

STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600

Stryker Corporation

FDA Devices Critical Aug 12, 2026

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAMC1000-05

AVID Medical, Inc.

FDA Devices Moderate Aug 12, 2026

Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11

THERANICA BIOELECTRONICS LTD

FDA Devices Moderate Aug 12, 2026

GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system

GE Medical Systems Information Technologies Inc

FDA Devices Moderate Aug 12, 2026

Brand Name: Quantum Rehab Product Name: Quantum 4Front 2 Model/Catalog Number: Quantum 4Front 2 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

Pride Mobility Products Corp.

FDA Devices Moderate Aug 12, 2026

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm

Biomet, Inc.

FDA Devices Moderate Aug 12, 2026

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

TISSIUM SA

FDA Devices Moderate Aug 12, 2026

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 Jaw 4 LC w/Needle 240cm Box 20; Outer Box UPN: M00513331; Inner Box UPN: M00513330. 4. Radial Jaw 4 LC w/Needle 240cm Box 40; Outer Box UPN: M00513332; Inner Box UPN: M00513330. 5. Radial Jaw 4 LC w/Needle 240c

Boston Scientific Corporation

FDA Devices Moderate Aug 12, 2026

munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System

MUNEVO GMBH

FDA Devices Moderate Aug 12, 2026

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 Description: Manual Orthopedic Surgical Instrument Component: No

United Orthopedic Corp.

FDA Devices Moderate Aug 12, 2026

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm

Biomet, Inc.

FDA Devices Moderate Aug 12, 2026

Merge PACS, medical imaging diagnostic workstation

Merge Healthcare, Inc.

FDA Devices Moderate Aug 12, 2026

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm

Biomet, Inc.

FDA Devices Moderate Aug 12, 2026

Brand Name: Quantum Rehab Product Name: 4Front Model/Catalog Number: 4Front Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

Pride Mobility Products Corp.

FDA Devices Moderate Aug 12, 2026

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

Pride Mobility Products Corp.

FDA Devices Critical Aug 12, 2026

INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spinal Cord Stimulator (SCS) Systems.

Boston Scientific Neuromodulation Corporation

FDA Devices Moderate Aug 12, 2026

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 and identifies Bacillus anthracis, Yersinia pestis, Francisella tularensis, Coxiella burnetii, Ebola virus, and Marburg virus nucleic acids directly from human whole blood (EDTA).

Biofire Defense

FDA Devices Moderate Aug 12, 2026

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No

TISSIUM SA

FDA Devices Moderate Aug 12, 2026

Brand Name: Quantum Rehab Product Name: Q6 Edge HD Model/Catalog Number: Q6 Edge HD Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

Pride Mobility Products Corp.

FDA Devices Moderate Aug 12, 2026

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

Pride Mobility Products Corp.

FDA Devices Moderate Aug 12, 2026

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 baumannii complex and Stenotrophomonas maltophilia to Cefiderocol,

Hardy Diagnostics

FDA Devices Moderate Aug 12, 2026

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

TISSIUM SA

FDA Devices Moderate Aug 12, 2026

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm

Biomet, Inc.

FDA Devices Moderate Aug 12, 2026

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

Pride Mobility Products Corp.

FDA Devices Moderate Aug 12, 2026

Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791

Medical Action Industries, Inc. 306

FDA Devices Moderate Aug 12, 2026

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

Pride Mobility Products Corp.

FDA Devices Moderate Aug 12, 2026

REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections

Beckman Coulter Biomedical GmbH

FDA Devices Moderate Aug 12, 2026

Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO charger. G4 PRO Black US - Refurb., SKU TG02428-01 G4 PRO NA, SKU G4-PRO-PKG-NA G4-PRO-PKG-US, SKU G4 PRO US G4 PRO Black US - Refurb V, SKU TG0002428-1V10 Pro Charger Single Unit, SKU PRO-CHARGER-SINGLE

Therabody, Inc

FDA Devices Moderate Aug 12, 2026

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 chain reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for us

Nuclein LLC

FDA Devices Moderate Aug 12, 2026

REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument

Beckman Coulter Inc.

FDA Devices Moderate Aug 12, 2026

Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Critical Aug 12, 2026

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05

AVID Medical, Inc.

FDA Devices Moderate Aug 12, 2026

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 heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory.

Instrumentation Laboratory

FDA Devices Moderate Aug 12, 2026

Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-6-30, NG-NV-6-40, NG-NV-7-30, NG-NV-7-40

Contego Medical, Inc

FDA Devices Moderate Aug 12, 2026

Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12; Model Number: 722227. 4. Azurion 5 M20; Model Numbers: 722228, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225. 6. Azurion 7 B20; Model Numbers: 722068, 722226. 7. Azurion 7 M12; Model Numbers: 722078, 722223. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 7222

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Low Aug 12, 2026

Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Aug 12, 2026

STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530

Stryker Corporation

FDA Devices Moderate Aug 12, 2026

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

Pride Mobility Products Corp.

FDA Devices Moderate Aug 12, 2026

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm

Biomet, Inc.

FDA Devices Moderate Aug 12, 2026

5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905

Aniara Diagnostica LLC

FDA Devices Moderate Aug 12, 2026

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

TISSIUM SA

FDA Devices Moderate Aug 12, 2026

5-PLASMA Bivalirudin Control, Model Number 5D-44905

Aniara Diagnostica LLC

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Data Sources

  • Source: FDA openFDA Enforcement API - calendar-year recall filings for food, drugs, and devices
  • Source: USDA FSIS Recalls - calendar-year meat, poultry, and processed egg product recall filings
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2026

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS and NHTSA recall records; no number is typed in by an editor. Figures cover calendar year 2026 across the FDA, CPSC, USDA FSIS and NHTSA federal recall feeds. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of September 2026.