PlainRecalls

2025 Recalls

5,015 recalls · Page 80 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 9 critical, 41 moderate, and 0 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, NHTSA, or USDA FSIS for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Moderate Mar 26, 2025

CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DR…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

C-SECTION PACK, Model Nos LLCS44F LLCS44F-01

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV40…

Remel, Inc

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-…

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 26, 2025

VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information syst…

Merge Healthcare, Inc.

FDA Devices Moderate Mar 26, 2025

DIAGNOSTIC NEURO IR TRAY , Model No WENE21

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

DELIVERY PACK , Model No SGDV22D-01 SGDV22E

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric, PT00156254 …

Oridion Medical 1987 Ltd.

FDA Devices Moderate Mar 26, 2025

VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integr…

Merge Healthcare, Inc.

FDA Devices Moderate Mar 26, 2025

OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I

American Contract Systems Inc

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introd…

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

LAPAROSCOPY PACK , Model No SFLA02A SFLA02B

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

CYSTO , Model No SACY80R

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Car…

Merge Healthcare, Inc.

FDA Devices Moderate Mar 26, 2025

DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.

American Contract Systems Inc

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-…

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information …

Merge Healthcare, Inc.

FDA Devices Moderate Mar 26, 2025

Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in t…

Immuno-Mycologics, Inc

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introd…

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - OmniVentLine Set Adult-Pedi…

Oridion Medical 1987 Ltd.

FDA Devices Moderate Mar 26, 2025

Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 26, 2025

Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11

Waldemar Link GmbH & Co. KG (Mfg Site)

FDA Devices Moderate Mar 26, 2025

VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - …

Oridion Medical 1987 Ltd.

FDA Devices Moderate Mar 26, 2025

Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. Sterile surg…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 26, 2025

Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0…

Microbiologics Inc

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

CYSTO PACK , Model N. HKCY31A

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 11…

ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY

FDA Devices Moderate Mar 26, 2025

BORN ON ARRIVAL KIT , Model No LLBN11B

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13

Waldemar Link GmbH & Co. KG (Mfg Site)

FDA Devices Moderate Mar 26, 2025

GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03

American Contract Systems Inc

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1

Brainlab AG

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

AV FISTULA , Model No UTAV77T

American Contract Systems Inc

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 - Micros…

Oridion Medical 1987 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 + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2025