PlainRecalls

2025 Recalls

5,015 recalls · Page 96 of 101

2025 Recall Year Insight

Federal agencies issued 5,015 product recalls indexed by PlainRecalls in calendar year 2025. That represents about 5.97% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 13.7 recalls per day across the FDA, CPSC, 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 101 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 7 critical, 43 moderate, and 0 lower-severity recalls. The page references 19 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, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Moderate Jan 22, 2025

Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC42; 3) CHI S…

Cardinal Health 200, LLC

FDA Devices Critical Jan 22, 2025

Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.

Trokamed GmbH

FDA Devices Moderate Jan 22, 2025

NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX

NOA Medical Industries Inc

FDA Devices Moderate Jan 22, 2025

GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Critical Jan 22, 2025

VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)

Boston Scientific Corporation

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A, gynecological procedures

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution component…

GE Medical Systems, LLC

FDA Devices Moderate Jan 22, 2025

VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064

Accriva Diagnostics, Inc.

FDA Devices Moderate Jan 22, 2025

GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5) H3100AG, 6) H3100JW…

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A; 2) ECONO STERILE WEI…

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STE…

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

McKesson Cardiology Hemo software

A L I Technologies Ltd

FDA Devices Moderate Jan 22, 2025

OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.

IsoTis OrthoBiologics, Inc.

FDA Devices Moderate Jan 22, 2025

Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.

Augustine Temperature Management, LLC

FDA Devices Moderate Jan 22, 2025

ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); …

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361

DRG International, Inc.

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A; orthopedic surgery

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

8MM,CADIERE FORCEPS,IS4000 REF 471049

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PG…

Cardinal Health 200, LLC

FDA Devices Critical Jan 22, 2025

Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP

Baxter Healthcare Corporation

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RE…

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603; 2) ECONO STERILE GRAVES SPE…

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X …

ev3 Inc

FDA Devices Moderate Jan 22, 2025

Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Appl…

QUIDEL ORTHO

FDA Devices Moderate Jan 22, 2025

Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.

Cook Biotech, Inc.

FDA Devices Moderate Jan 22, 2025

Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952; 3) KIT,ORP PLAST…

Cardinal Health 200, LLC

FDA Devices Moderate Jan 22, 2025

Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile

Cook Biotech, Inc.

FDA Devices Critical Jan 22, 2025

ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)

Boston Scientific Corporation

FDA Devices Moderate Jan 22, 2025

Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"…

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352

CareFusion 303, Inc.

FDA Devices Moderate Jan 22, 2025

8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to p…

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.

IsoTis OrthoBiologics, Inc.

FDA Devices Moderate Jan 22, 2025

8MM,FORCE BIPOLAR,IS4000 REF 471405

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of …

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M

Sklar Instruments

FDA Devices Critical Jan 22, 2025

Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.

Trokamed GmbH

FDA Devices Moderate Jan 22, 2025

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo…

Augustine Temperature Management, LLC

FDA Devices Moderate Jan 22, 2025

8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296

Intuitive Surgical, Inc.

FDA Devices Critical Jan 22, 2025

Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 10508…

Mercury Enterprises, Inc. dba Mercury Medical

FDA Devices Moderate Jan 22, 2025

8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO STERILE TISS N…

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

Change Healthcare Cardiology Hemodynamics software

A L I Technologies Ltd

FDA Devices Moderate Jan 22, 2025

GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS; System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Jan 22, 2025

GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Critical Jan 22, 2025

ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)

Boston Scientific Corporation

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: CPSC + NHTSA — consumer product and vehicle recall feeds for 2025