2025 Recalls
6,236 federal recalls indexed for 2025 · Page 41 of 125
2025 Recall Year Insight
Federal agencies issued 6,236 product recalls indexed by PlainRecalls in calendar year 2025. That represents about 5.97% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 17.1 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 125 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 2025.
On this page of 50 records, severity classification shows 13 critical, 37 moderate, and 0 lower-severity recalls. The page references 27 distinct recalling firms operating in 7 distinct product categories, with 41 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (35), NHTSA (8), FDA Drug (4), 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 2025 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.
Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19.
Unichem Pharmaceuticals USA Inc.
Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
Zydus Pharmaceuticals (USA) Inc
Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc., Princeton, NJ 08540, Product of India, Vial NDC# 0781-3528-75, Carton NDC# 0781-3528-10.
Sandoz Inc
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-307-84), d) 20-count bottles (NDC 51655-307-20) Rx Only, Repackaged from Amneal Pharmaceuticals LLC. Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46203.
Northwind Pharmaceuticals LLC
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable
Agilent Technologies Denmark ApS
i-STAT EG6+ cartridge. List Number: 03P77-25.
Abbott Point Of Care Inc.
3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
3M Company
Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Folsom Metal Products, Inc.
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Max Mobility LLC
Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
Maquet Cardiovascular, LLC
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
Folsom Metal Products, Inc.
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Max Mobility LLC
The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.
BigTree Sales Inc.
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Abbott Point Of Care Inc.
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
Beckman Coulter Inc.
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
C.R. Bard Inc
SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
C.R. Bard Inc
Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)
Exactech, Inc.
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Boston Scientific Neuromodulation Corporation
Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Pinnacle TumorLOC 16.2 Model 870226 UDI code: (01)00884838091122(10)16.2.0.60010 Pinnacle TumorLOC 16.2.1 Model 870227 UDI code: (01)00884838091122(10)16.2.1.60098 Pinnacle TumorLOC 16.0.2 Model 870218 UDI code: (01)00884838085602(10)16.0.2.60004 Pinnacle TumorLOC 14.0 Model 870200 UDI code: N/A Pinnacle3 Radiation Therapy Planning
Philips Medical Systems (Cleveland) Inc
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable
Agilent Technologies Denmark ApS
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
Maquet Cardiovascular, LLC
Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Folsom Metal Products, Inc.
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
Beckman Coulter Inc.
MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.
Medical Information Technology, Inc.
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
Abbott Point Of Care Inc.
VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
Ortho-Clinical Diagnostics, Inc.
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable
Agilent Technologies Denmark ApS
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
Beckman Coulter Inc.
Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Folsom Metal Products, Inc.
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
Beckman Coulter Inc.
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Max Mobility LLC
Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Folsom Metal Products, Inc.
SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216
C.R. Bard Inc
Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.
Ortho-Clinical Diagnostics, Inc.
Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/
Exactech, Inc.
Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
Maquet Cardiovascular, LLC
i-STAT EG7+ cartridge. List Number: 03P76-25.
Abbott Point Of Care Inc.
AUDI 2025: SEAT BELTS:FRONT:RETRACTOR
AUDI
AUDI 2025: FUEL SYSTEM, GASOLINE:DELIVERY:FUEL PUMP
AUDI
BMW,TOYOTA 2019-2022: ELECTRICAL SYSTEM:STARTER ASSEMBLY:RELAY
BMW,TOYOTA
PORSCHE 2024-2026: FUEL SYSTEM, GASOLINE:DELIVERY:FUEL PUMP
PORSCHE
ISUZU 2024: FUEL SYSTEM, OTHER:FUEL FILTER
ISUZU
FORD,LINCOLN 2020: ENGINE
FORD,LINCOLN
FORD 2020-2021: STEERING:COLUMN
FORD
GENESIS 2023-2025: STRUCTURE:EXTERIOR TRIM
GENESIS
FSIS Issues Public Health Alert for Ready-To-Eat Turkey Wrap Product Due To Possible Listeria Contamination
WCD Kitchen - Minooka
Arizer Solo II Portable Vaporizers Recalled Due to Fire and Burn Hazards; Imported by 7111495 Canada
EnHomee Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment; Violates Mandatory Standard for Clothing Storage Units; Sold by EnHomee Direct
Changzhou Jiaxuan Intelligent Furniture Co. Ltd., of China
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 2025
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 2025 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.