PlainRecalls

2025 Recalls

5,015 recalls · Page 18 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, NHTSA, and USDA FSIS 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 2 critical, 46 moderate, and 2 lower-severity recalls. The page references 18 distinct recalling firms operating in 3 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (44), FDA Drug (6), 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, NHTSA, or USDA FSIS for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Low Nov 5, 2025

Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestn…

Endo USA, Inc.

FDA Drug Moderate Nov 5, 2025

Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed …

SUN PHARMACEUTICAL INDUSTRIES INC

FDA Drug Moderate Nov 5, 2025

Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092.…

FARMAKEIO OUTSOURCING LLC

FDA Drug Low Nov 5, 2025

Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut…

Endo USA, Inc.

FDA Drug Moderate Nov 5, 2025

Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed …

SUN PHARMACEUTICAL INDUSTRIES INC

FDA Drug Moderate Nov 5, 2025

Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manu…

Heritage Pharmaceuticals Inc

FDA Devices Moderate Nov 5, 2025

Alcon PRECISION1 One-Day Contact Lenses, -2.25D.

Alcon Research LLC

FDA Devices Moderate Nov 5, 2025

Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;

PHILIPS MEDICAL SYSTEMS

FDA Devices Critical Nov 5, 2025

IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio

IMPRIS Imaging Inc

FDA Devices Moderate Nov 5, 2025

Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35

ICU Medical, Inc.

FDA Devices Critical Nov 5, 2025

IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida

IMPRIS Imaging Inc

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See…

Alcon Research LLC

FDA Devices Moderate Nov 5, 2025

BD Pyxis Pro MedStation Main, REF: 1155-00

CareFusion 303, Inc.

FDA Devices Moderate Nov 5, 2025

Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile,…

ENDOMAGNETICS LTD

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemosafeLock Connecter REF: KL-FNU3

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.

Canon Medical System, USA, INC.

FDA Devices Moderate Nov 5, 2025

ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system

Surgical Theater Inc

FDA Devices Moderate Nov 5, 2025

Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality

Surgical Theater Inc

FDA Devices Moderate Nov 5, 2025

Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;

PHILIPS MEDICAL SYSTEMS

FDA Devices Moderate Nov 5, 2025

CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. The…

Beckman Coulter, Inc.

FDA Devices Moderate Nov 5, 2025

Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Descriptio…

Aesculap Inc

FDA Devices Moderate Nov 5, 2025

Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.

Trividia Health, Inc.

FDA Devices Moderate Nov 5, 2025

ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system

Surgical Theater Inc

FDA Devices Moderate Nov 5, 2025

ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality

Surgical Theater Inc

FDA Devices Moderate Nov 5, 2025

Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description: REDU…

Aesculap Inc

FDA Devices Moderate Nov 5, 2025

Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Versio…

Medistim Asa

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-01 139045-01…

CareFusion 303, Inc.

FDA Devices Moderate Nov 5, 2025

SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood Collec…

ASP Global, LLC. dba Anatomy Supply Partners, 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: CPSC + NHTSA + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2025