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 21 critical, 29 moderate, and 0 lower-severity recalls. The page references 17 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 Critical Oct 22, 2025

Model Number L131, ESSENTIO DR EL MRI Pacemaker

Boston Scientific Corporation

FDA Devices Critical Oct 22, 2025

ACCOLADE DR EL MRI (Model L331)

Boston Scientific Corporation

FDA Devices Moderate Oct 22, 2025

Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393

Spacelabs Healthcare, Inc.

FDA Devices Moderate Oct 22, 2025

C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Goniotomy Instrument is a sterile single use disposable manual surgical instrument used in ophthalmic procedures for ab interno goniotomy and inner wall trabeculotomy.

Iantrek Inc.

FDA Devices Moderate Oct 22, 2025

Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M SHOULDER ARTHROSCOPY GRTS90G TOTAL SHPULDER PACK HGHI26G HIP PINNING PACK HJTO25C TOTAL HIP ACCESSORY PACK HNEX60L EXTREMITY PACK IAHD53C HAND PACK IASH65A SHOULDER PACK IHUE40AI UPPER EXTREMITY PK| STRL F G ILTJ47AA TOTAL JOINT PACK LMHP14Z ORIF HIP, ST LUKES METHODIS LMSN44AE SPINAL PACK MHHP25H HAND PACK - 206002 MHTH90AJ TOTAL HIP PACK - 206016 MWAH32P ANTER

American Contract Systems Inc.

FDA Devices Critical Oct 22, 2025

BRONCHOVIDEOSCOPE OLYMPUS BF-H1100

Olympus Corporation of the Americas

FDA Devices Critical Oct 22, 2025

Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-P-40-217-W ZTA2-P-42-121 ZTA2-P-42-121-W ZTA2-P-42-173 ZTA2-P-42-173-W ZTA2-P-42-225 ZTA2-P-42-225-W ZTA2-P-44-125 ZTA2-P-44-125-W ZTA2-P-44-179 ZTA2-P-44-179-W ZTA2-P-44-233 ZTA2-P-44-233-W ZTA2-P-46-125 ZTA2-P-46-125-W ZTA2-P-46-179 ZTA2-P-46-179-W ZTA2-P-46-233-W ZTA2-PT-40-36-167 ZTA2-PT-40-36-167-W ZTA2-PT-40-36-217 ZTA2-PT-40

Cook Medical Incorporated

FDA Devices Moderate Oct 22, 2025

Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723

Fisher & Paykel Healthcare, Ltd.

FDA Devices Critical Oct 22, 2025

BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150

Olympus Corporation of the Americas

FDA Devices Moderate Oct 22, 2025

Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis device is a manual surgical instrument used for the ab-interno construction or modification of a cyclodialysis, followed by delivery of viscous materials, bio-tissue/allograft, or other materials to reinforce and maintain the cleft.

Iantrek Inc.

FDA Devices Critical Oct 22, 2025

Model Number L121 ESSENTIO DR EL Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Oct 22, 2025

LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533

GE Medical Systems, LLC

FDA Devices Moderate Oct 22, 2025

Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACK - 205956, ANLP25AJ LAPROSCOPY PACK - 205958, FYLA38E LAPCHOLAPPY PACK, IHDA88AH DIVINCI GYN URO, IHLC11AE LAP GENERAL PACK, MHLP45AJ LAPAROSCOPY PACK - 206005, MHRB88AO ROBOTIC PACK - 242561, RCLC51C LAP CHOLE RCH 0246969, SMLC53C LAP CHOLE PACK, UDLC17AE DSC LAP CHOLE PACK - 206062, UIRU84AE ROBOTIC UROLOGY PACK (PS 060571)

American Contract Systems Inc.

FDA Devices Critical Oct 22, 2025

Model Number L110, ESSENTIO SR SL MRI Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Oct 22, 2025

Baxter Healthcare Corporation

FDA Devices Critical Oct 22, 2025

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190

Olympus Corporation of the Americas

FDA Devices Moderate Oct 22, 2025

The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard.

Insulet Corporation

FDA Devices Critical Oct 22, 2025

Model Number U225 VISIONIST CRT-P EL

Boston Scientific Corporation

FDA Devices Critical Oct 22, 2025

EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190

Olympus Corporation of the Americas

FDA Devices Moderate Oct 22, 2025

Baxter Healthcare Corporation

FDA Devices Critical Oct 22, 2025

Model Number L210 PROPONENT SR SL Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Oct 22, 2025

Medical convenience kits UDPG88W PICC G-TUBE PACK-230209

American Contract Systems Inc.

FDA Devices Moderate Oct 22, 2025

Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK

American Contract Systems Inc.

FDA Devices Moderate Oct 22, 2025

Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393

Spacelabs Healthcare, Inc.

FDA Devices Moderate Oct 22, 2025

BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO MODULAR CERAMIC MD 51 13007 ENDO MODULAR CERAMIC SH 41 13008 ENDO MODULAR CERAMIC SH 43 13009 ENDO MODULAR CERAMIC SH 45 13010 ENDO MODULAR CERAMIC SH 47 13011 ENDO MODULAR CERAMIC SH 49 13014 ENDO MODULAR CERAMIC MD 41 13015 ENDO MODULAR CERAMIC MD 43 13016 ENDO MODULAR CERAMIC MD 45 13017 ENDO MODULAR CERAMIC MD 47 1301

BioPro, Inc.

FDA Devices Moderate Oct 22, 2025

Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CARDIAC CATH TRINITY UICC27AG CARDIAC CATH ANGIO PACK (PS 923077) UIRD89AH RADIAL PACK (PS 56573)

American Contract Systems Inc.

FDA Devices Moderate Oct 22, 2025

Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK

American Contract Systems Inc.

FDA Devices Critical Oct 22, 2025

ACCOLADE DR SL (Model L301)

Boston Scientific Corporation

FDA Devices Moderate Oct 22, 2025

BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT 14095 HEAD FEMORAL 32 MD LT 14096 HEAD FEMORAL 32 LG LT

BioPro, Inc.

FDA Devices Moderate Oct 22, 2025

XERF EFFECTOR 60. Electrosurgical unit.

Lutronic Corporation

FDA Devices Critical Oct 22, 2025

ACCOLADE DR EL (Model L321)

Boston Scientific Corporation

FDA Devices Critical Oct 22, 2025

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190

Olympus Corporation of the Americas

FDA Devices Critical Oct 22, 2025

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter

Abbott

FDA Devices Moderate Oct 22, 2025

Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK - 205939 ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953 CFLA39G LAPAROTOMY PACK CIBL33I BASIC LAP PACK EVMN24E MINOR ESC EVST48E STARTER FDTA11AA T & A PACK FHHY25P HYSTEROSCOPY PACK HGML99G MAJOR LAP PACK HGXR41H X-RAY PACK HISU54M SET-UP PACK IHAA19AP PK A A A IHMP89K MINOR PROCEDURE PACK IHPD14AM PK PEDIATRIC LKVG10O VAG DELIVERY LMAG20G VASCULAR PACK

American Contract Systems Inc.

FDA Devices Moderate Oct 22, 2025

CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) 72404466 (12CM IP IZ), (7) 72404467 (14CM IP IZ), (8) 72404468 (16CM IP IZ), (9) 72404469 (18CM IP IZ);

Boston Scientific Corporation

FDA Devices Moderate Oct 22, 2025

CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);

Boston Scientific Corporation

FDA Devices Critical Oct 22, 2025

Model Number S701 ALTRUA 2 SR SL Pacemaker

Boston Scientific Corporation

FDA Devices Critical Oct 22, 2025

Model Number L111, ESSENTIO DR SL MRI Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Oct 22, 2025

LOGIQ P10 series with software version R4.5.7 Model Number 5877534

GE Medical Systems, LLC

FDA Devices Moderate Oct 22, 2025

Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACEMAKER PACK- 206010 UDBH37AW BASIC HEART PACK - 206044 UHPP82AH PERIPHERAL PACK - 209533 UICD62AN CARDIOVASCUALR SUPPLY (PS 907285) UICT16F CARDIO THORACIC DRAPE PACK (PS 907284) UIVA75I VASCULAR PACK

American Contract Systems Inc.

FDA Devices Critical Oct 22, 2025

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60

Olympus Corporation of the Americas

FDA Devices Critical Oct 22, 2025

ACCOLADE SR SL (Model L300)

Boston Scientific Corporation

FDA Devices Critical Oct 22, 2025

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190

Olympus Corporation of the Americas

FDA Devices Moderate Oct 22, 2025

DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas subject to friction and those requiring contouring, e.g., elbows, heels. DuoDERM" Extra Thin dressings interact with wound moisture producing a soft mass that enables removal of the dressing with little or no damage to newly formed tissues. They help isolate the wound against bacterial and other exte

ConvaTec, Inc

FDA Devices Critical Oct 22, 2025

Model Number U125, VALITUDE CRT-P EL

Boston Scientific Corporation

FDA Devices Moderate Oct 22, 2025

LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) 72404456 (15CM IP IZ), (7) 72404457 (18CM IP IZ), (8) 72404458 (21CM IP IZ);

Boston Scientific Corporation

FDA Devices Moderate Oct 22, 2025

Baxter Healthcare Corporation

FDA Devices Moderate Oct 22, 2025

Medline Adult Anesthesia Set, REF DYNJ39985G

Medline Industries, LP

FDA Devices Moderate Oct 22, 2025

Cardiac Workstation 7000; Model Number: 860441;

Philips North America

FDA Devices Moderate Oct 22, 2025

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

Contego Medical 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.