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 0 critical, 20 moderate, and 30 lower-severity recalls. The page references 11 distinct recalling firms operating in 1 distinct product categories, with 50 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 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 Sep 3, 2025

TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631

VANTIVE US HEALTHCARE LLC

FDA Devices Low Sep 3, 2025

L15-7io Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

X5-1c Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

L12-4 Lumify Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

S7-3t Transducer Probe

Philips Ultrasound, Inc

FDA Devices Moderate Sep 3, 2025

Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model.

Dentsply IH, Inc.

FDA Devices Low Sep 3, 2025

S5-2 Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

3D6-2 Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

C9-4v Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

S3-1 Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

S8-3t Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

D5cwc Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

Transducer C10-3v Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

X11-4t Transducer Probe

Philips Ultrasound, Inc

FDA Devices Moderate Sep 3, 2025

IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC POWEREASE System is also used in the placement of screws, or cutting of screws, posts, and rods. The IPC is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in

Medtronic Xomed, Inc.

FDA Devices Low Sep 3, 2025

L12-3 Transducer Probe

Philips Ultrasound, Inc

FDA Devices Moderate Sep 3, 2025

STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.

Diagnostica Stago, Inc.

FDA Devices Moderate Sep 3, 2025

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item Number JKLC55H; 4) LAPAROSCOPY PACK, Model/Item Number LLLA21K; 5) GENERAL LAPAROSCOPY MPH, Model/Item Number MPGL15G;

American Contract Systems Inc

FDA Devices Low Sep 3, 2025

Mini Multi TEE Transducer Probe

Philips Ultrasound, Inc

FDA Devices Moderate Sep 3, 2025

BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF: 515004 BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 515005 BD PhaSeal Protector (P14), REF: 515100 BD PhaSeal Protector (P21), REF: 515102 BD PhaSeal Protector (P21 Multi), REF: 515103 BD PhaSeal Protector (P28), REF: 515104 BD PhaSeal Protector (P50), REF: 515105 BD PhaSeal Protector (P50 Multi), REF: 515106 BD PhaSeal Protector (P53), REF: 515

BD SWITZERLAND SARL

FDA Devices Moderate Sep 3, 2025

Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles. Component: No

THOR Photomedicine Ltd

FDA Devices Moderate Sep 3, 2025

STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determination of fibrinogen levels in human citrated plasma by the clotting method of Clauss.

Diagnostica Stago, Inc.

FDA Devices Low Sep 3, 2025

S4-1 Transducer Probe

Philips Ultrasound, Inc

FDA Devices Moderate Sep 3, 2025

Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles. Component: N/A

THOR Photomedicine Ltd

FDA Devices Moderate Sep 3, 2025

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.

American Contract Systems Inc

FDA Devices Moderate Sep 3, 2025

Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles. Component: No

THOR Photomedicine Ltd

FDA Devices Low Sep 3, 2025

c5-1 Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

V6-2 Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

C9-4 Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

L12-5 50 Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

V9-2 Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

XL14-3 Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

X8-2t Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

C9-3io Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

L11-3 Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

OMNI III TEE Transducer Probe

Philips Ultrasound, Inc

FDA Devices Moderate Sep 3, 2025

Orascoptic Superior Visualization Custom loupes with Dragonfly frames

Orascoptic Surgical Acuity

FDA Devices Low Sep 3, 2025

D2TCD Transducer Probe

Philips Ultrasound, Inc

FDA Devices Moderate Sep 3, 2025

ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.

Onkos Surgical, Inc.

FDA Devices Moderate Sep 3, 2025

Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29000J14, 29030J14, 29000J14S; Bard Silver Lubri-Sil Foley Tray Temperature Sensing, Complete Care with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29030J

C.R. Bard Inc

FDA Devices Moderate Sep 3, 2025

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; 4) TUR BASIN PACK, Model/Item Number LMTU31T; 5) CYSTO, Model/Item Number SACY80S; 6) UROLOGY PACK, Model/Item Number SPUR64F.

American Contract Systems Inc

FDA Devices Low Sep 3, 2025

C5-2 Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

L15-7IO TRANSDUCER Transducer Probe

Philips Ultrasound, Inc

FDA Devices Moderate Sep 3, 2025

ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.

Onkos Surgical, Inc.

FDA Devices Low Sep 3, 2025

X7-2t Transducer Probe

Philips Ultrasound, Inc

FDA Devices Moderate Sep 3, 2025

ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.

Onkos Surgical, Inc.

FDA Devices Moderate Sep 3, 2025

Orascoptic Superior Visualization Custom loupes configured with Phantom Frames

Orascoptic Surgical Acuity

FDA Devices Moderate Sep 3, 2025

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.

American Contract Systems Inc

FDA Devices Low Sep 3, 2025

L17-5 Transducer Probe

Philips Ultrasound, Inc

FDA Devices Moderate Sep 3, 2025

PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724

VANTIVE US HEALTHCARE LLC

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.