PlainRecalls

2025 Recalls

Compiled from official public sources by the editorial team.

6,168 recalls · Page 23 of 124

2025 Recall Year Insight

Federal agencies issued 6,168 product recalls indexed by PlainRecalls in calendar year 2025. That represents about 6.06% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 16.9 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 124 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 3 critical, 47 moderate, and 0 lower-severity recalls. The page references 15 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 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.

FDA Devices Critical Nov 5, 2025

Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT0911…

BALT USA, LLC

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock Port REF: CL2100

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated…

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33

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

ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer R…

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;

PHILIPS MEDICAL SYSTEMS

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock Bag Spike REF: CL-10

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;

DAYE (ANNE'S DAY LTD)

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

Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system

Surgical Theater Inc

FDA Devices Moderate Nov 5, 2025

Trial Tampon Box; Model Number: FG-TMP-REF04050504;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136

ICU Medical, Inc.

FDA Devices Critical Nov 5, 2025

Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Sof…

Dexcom, Inc.

FDA Devices Moderate Nov 5, 2025

Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00

CareFusion 303, Inc.

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock Closed Vial Spike REF: CL-80

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01

MicroSurgical Technology Inc

FDA Devices Moderate Nov 5, 2025

Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

Fresenius Kabi USA, LLC

FDA Devices Moderate Nov 5, 2025

Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system

Surgical Theater Inc

FDA Devices Moderate Nov 5, 2025

ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176

ICU Medical, Inc.

FDA Devices Critical Nov 5, 2025

IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA

IMPRIS Imaging Inc

FDA Devices Moderate Nov 5, 2025

Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322

Greiner Bio-One North America, Inc.

FDA Devices Moderate Nov 5, 2025

Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagen…

Cepheid

FDA Devices Moderate Nov 5, 2025

Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

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

Surgical Theater Inc

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented…

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), a…

Vantive US Healthcare LLC

FDA Devices Moderate Nov 5, 2025

9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900;

DAYE (ANNE'S DAY LTD)

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Figures cover calendar year 2025 across the FDA, CPSC 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 July 2026.