PlainRecalls

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, 36 moderate, and 1 lower-severity recalls. The page references 33 distinct recalling firms operating in 8 distinct product categories, with 42 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (32), CPSC (8), NHTSA (7), 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.

FDA Devices Moderate Jul 2, 2025

Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many pati

Encore Medical, LP

FDA Devices Moderate Jul 2, 2025

REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly

Becton Dickinson Infusion Therapy Systems, Inc.

FDA Devices Moderate Jul 2, 2025

BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).

Becton Dickinson & Co.

FDA Devices Moderate Jul 2, 2025

Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 2, 2025

REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly

Becton Dickinson Infusion Therapy Systems, Inc.

FDA Devices Moderate Jul 2, 2025

CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Jul 2, 2025

REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY

Becton Dickinson Infusion Therapy Systems, Inc.

FDA Devices Moderate Jul 2, 2025

PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile

Limacorporate S.p.A

FDA Devices Moderate Jul 2, 2025

Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)

RECORDATI RARE DISEASES INC.

FDA Devices Moderate Jul 2, 2025

Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many pati

Encore Medical, LP

FDA Devices Moderate Jul 2, 2025

Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.

Jewel Precision Sheet Metal & Machining Co, Inc.

FDA Devices Critical Jul 2, 2025

Extended Tip Applicator, 15 CM, Box of 5.

Integra LifeSciences Corp. (NeuroSciences)

FDA Devices Moderate Jul 2, 2025

REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly

Becton Dickinson Infusion Therapy Systems, Inc.

FDA Devices Moderate Jul 2, 2025

REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly

Becton Dickinson Infusion Therapy Systems, Inc.

FDA Devices Critical Jul 2, 2025

Extended Tip Applicator, 8CM, Box of 5.

Integra LifeSciences Corp. (NeuroSciences)

FDA Devices Moderate Jul 2, 2025

REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413; C73942; C73941; C88470; C88471 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS&). It can also be connected to a host system. It provides data management capabilities such as automatic results validation, delta checking, reflex testing, quality

Beckman Coulter Inc.

FDA Devices Moderate Jul 2, 2025

Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303], BD Pyxis MedStation ES Tower 10885403512674 [352], BD Pyxis Anesthesia Station ES 10885403477836 [327], BD Pyxis MedStation ES (Main) 10885403512667 [323], MD BD Pyxis SupplyStation V9 [317], Security Module [139698-01], BD Knowledge Portal for Medication Technologies [136607-01], STOCKSTN V10.X WRD/WL SCANNERS [132-53-02], PRS STOCKSTN V10.X WRD/

CareFusion 303, Inc.

FDA Devices Moderate Jul 2, 2025

Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many pati

Encore Medical, LP

FDA Devices Critical Jul 2, 2025

Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.

SunMed Holdings, LLC

FDA Devices Moderate Jul 2, 2025

REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly

Becton Dickinson Infusion Therapy Systems, Inc.

FDA Devices Moderate Jul 2, 2025

Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.

Jewel Precision Sheet Metal & Machining Co, Inc.

FDA Devices Moderate Jul 2, 2025

Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Configuration, Rev H The Bigfoot Unity Diabetes Management System that include the Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting Insulin Pen Cap [LCAP]) integrates continuous monitoring with insulin dose recommendations. The Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting

BIGFOOT BIOMEDICAL

FDA Devices Critical Jul 2, 2025

Extended Tip Applicator 8CM, Box of 1.

Integra LifeSciences Corp. (NeuroSciences)

FDA Devices Moderate Jul 2, 2025

LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.

Jolife AB

FDA Devices Moderate Jul 2, 2025

PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile

Limacorporate S.p.A

FDA Devices Moderate Jul 2, 2025

REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly

Becton Dickinson Infusion Therapy Systems, Inc.

FDA Devices Moderate Jul 2, 2025

DxI 9000 Access Immunoassay Analyzer C11137

Beckman Coulter, Inc.

FDA Devices Critical Jul 2, 2025

MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.

Integra LifeSciences Corp. (NeuroSciences)

FDA Devices Moderate Jul 2, 2025

Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Jul 2, 2025

GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus 5PP, Model/Catalog Number 5938561; 5) Versana Premier R3 VA Vet, Model/Catalog Number 5946387; 6) Versana Premier R3 VS Vet, Model/Catalog Number 5946481. 7) Versana Premier R3 Expert, Mode

GE Medical Systems China Co., Ltd.

FDA Devices Moderate Jul 2, 2025

Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system

Barco N.V.

FDA Devices Moderate Jul 2, 2025

Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to download through the Apple app store. The Omnipod 5 App is the user interface that controls the Omnipod 5 Automated Insulin Delivery System. It is used to activate/deactivate Pods, display alerts/alarms, and send insulin delivery commands for execution to the Pod. Only available in the US.

Insulet Corporation

NHTSA No agency class Jul 2, 2025

POLESTAR 2021-2024: SERVICE BRAKES, HYDRAULIC:POWER ASSIST:ELECTRIC:CONTROL MODULE:SOFTWARE

POLESTAR

USDA FSIS Critical Jul 2, 2025

Kraft Heinz Foods Company Recalls Turkey Bacon Products Due to Possible Listeria Contamination

Kraft Heinz Foods Company

USDA FSIS Moderate Jul 2, 2025

FSIS Issues Public Health Alert for Ready-to-eat Beef Jerky Stick Products Due to Possible Extraneous Material Contamination

Top Notch Jerky LLC

NHTSA No agency class Jun 30, 2025

VOLKSWAGEN 2023-2025: SERVICE BRAKES

VOLKSWAGEN

NHTSA No agency class Jun 27, 2025

FORD,LINCOLN 2018-2024: BACK OVER PREVENTION:SOFTWARE

FORD,LINCOLN

NHTSA No agency class Jun 27, 2025

FORD 2022: ELECTRICAL SYSTEM:PROPULSION SYSTEM:TRACTION BATTERY:MANAGEMENT SYSTEM/ENERGY CONTROL MODULE (BMS/BECM)

FORD

NHTSA No agency class Jun 27, 2025

FORD,LINCOLN 2025: AIR BAGS:FRONTAL

FORD,LINCOLN

NHTSA No agency class Jun 27, 2025

FORD 2025: SERVICE BRAKES, HYDRAULIC:FOUNDATION COMPONENTS:HOSES, LINES/PIPING, AND FITTINGS

FORD

NHTSA No agency class Jun 27, 2025

INFINITI,NISSAN 2019-2024: ENGINE AND ENGINE COOLING:ENGINE:HARD PARTS INTERNAL/MECHANICAL

INFINITI,NISSAN

USDA FSIS Low Jun 27, 2025

Gaiser's European Style Provisions Inc. Recalls Ready-To-Eat Meat and Poultry Bologna Products Due to Misbranding

Gaiser's European Style Provisions Inc.

CPSC No agency class Jun 26, 2025

Bell Sports Recalls Bicycle Helmets Due to Risk of Head Injury; Violation of Federal Standard for Bicycle Helmets

Bell Sports Inc., of Irvine, California

CPSC No agency class Jun 26, 2025

Boyro Baby Walkers Recalled Due to Risk of Serious Injury or Death to Children from Fall Hazard; Violations of the Federal Standard for Infant Walkers and Lead Content Ban; Sold Exclusively on Amazon.com

Hangzhou Christine Trading Co. Ltd., dba Boyro Baby, of China

CPSC No agency class Jun 26, 2025

DR Power Recalls Lithium-Ion Battery Packs Due to Fire and Burn Hazards

Ningbo New Team Import & Export Co. Ltd. ("Lera"), of China

CPSC No agency class Jun 26, 2025

iHerb Recalls Bottles and Blister Packs of California Gold Nutrition Iron Supplements Due to Risk of Serious Injury or Death from Child Poisoning; Violation of Federal Standard for Child Resistant Packaging

iHerb LLC, dba Madre Labs LLC, of Irvine, California

CPSC No agency class Jun 26, 2025

LED Fireplace Lanterns Recalled Due to Risk of Serious Injury or Death from Ingestion Hazard; Violations of Federal Standard for Consumer Products with Coin Batteries; Imported by Green Pastures Wholesale

CPSC No agency class Jun 26, 2025

Peg Perego Recalls Tatamia 3-in-1 Recliners, Swings and High Chairs Due to Risk of Suffocation; Violations of Multiple Federal Standards (Recall Alert)

Peg Perego SPA, of Italy

CPSC No agency class Jun 26, 2025

Professional's Choice Sports Medicine Products Recalls Equine Bits Due to Fall Hazard

CPSC No agency class Jun 26, 2025

Sanven Technology Recalls Vevor Handrails Due to Injury Hazard

Sanven Technology Ltd., dba Vevor, of Rancho Cucamonga, California

Nearby Recall Years

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

Compare 2025 with 2024 →

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.