PlainRecalls

2025 Recalls

6,168 recalls · Page 57 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 6 critical, 44 moderate, and 0 lower-severity recalls. The page references 27 distinct recalling firms operating in 4 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (41), FDA Drug (7), FDA Food (2), 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 Food Moderate Aug 6, 2025

Reisman's Chocolate Croissants 3 oz.

Reisman Bros Bakery

FDA Food Critical Aug 6, 2025

Sheehan Brothers Vending Chili Cheese Coney, 4.3 oz (120g), in a red and white paper boat and individually wrapped in plastic, UPC: 100000222027

SHEEHAN BROTHERS VENDING

FDA Drug Moderate Aug 6, 2025

Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 341…

Lupin Pharmaceuticals Inc.

FDA Drug Moderate Aug 6, 2025

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Di…

FDC Limited

FDA Drug Moderate Aug 6, 2025

Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactur…

Nostrum Laboratories, Inc.

FDA Drug Moderate Aug 6, 2025

Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 1…

Pfizer Inc.

FDA Drug Moderate Aug 6, 2025

Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25

Hikma Pharmaceuticals USA Inc.

FDA Drug Moderate Aug 6, 2025

Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 1…

Pfizer Inc.

FDA Drug Moderate Aug 6, 2025

Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma I…

Strides Pharma, Inc.

FDA Devices Critical Aug 6, 2025

Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product …

Abiomed, Inc.

FDA Devices Moderate Aug 6, 2025

RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.

Siemens Healthcare Diagnostics Inc

FDA Devices Critical Aug 6, 2025

SafeStar 90 Plus Filter. Bidirectionally breathing system filter.

Draeger, Inc.

FDA Devices Moderate Aug 6, 2025

Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);

Philips North America

FDA Devices Moderate Aug 6, 2025

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.

Fresenius Kabi USA, LLC

FDA Devices Moderate Aug 6, 2025

Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems

Steris Corporation

FDA Devices Moderate Aug 6, 2025

BostonSight SCLERAL Lens

Boston Foundation For Sight

FDA Devices Moderate Aug 6, 2025

BostonSight PROSE Lens.

Boston Foundation For Sight

FDA Devices Moderate Aug 6, 2025

Blood Agar,5% Sheep Blood 100/PK, Product Number R01202

Remel, Inc

FDA Devices Moderate Aug 6, 2025

Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems

Steris Corporation

FDA Devices Moderate Aug 6, 2025

SmartPath to dStream for 3.0T Model Number (REF): 782145;

Philips North America

FDA Devices Moderate Aug 6, 2025

3M Ranger Irrigation Fluid Warming Set, REF 24750

3M Company

FDA Devices Moderate Aug 6, 2025

Ingenia 1.5T S Model Number (REF): 781347;

Philips North America

FDA Devices Moderate Aug 6, 2025

LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)

Microbiologics Inc

FDA Devices Moderate Aug 6, 2025

Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;

Philips North America

FDA Devices Critical Aug 6, 2025

SafeStar 55 Plus Filter. Bidirectionally breathing system filter.

Draeger, Inc.

FDA Devices Moderate Aug 6, 2025

Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5) Software …

Osteotec Limited

FDA Devices Moderate Aug 6, 2025

MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;

Philips North America

FDA Devices Moderate Aug 6, 2025

Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;

Philips North America

FDA Devices Moderate Aug 6, 2025

The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounti…

Implant Direct Sybron Manufacturing LLC

FDA Devices Moderate Aug 6, 2025

Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;

Philips North America

FDA Devices Moderate Aug 6, 2025

Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Cels…

INSTITUT GEORGES LOPEZ

FDA Devices Moderate Aug 6, 2025

Upgrade to MR 7700 Model Number (REF): 782130;

Philips North America

FDA Devices Moderate Aug 6, 2025

Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;

Philips North America

FDA Devices Moderate Aug 6, 2025

Blood/MacConkey Biplate 100/PK, Product Number R02049

Remel, Inc

FDA Devices Moderate Aug 6, 2025

Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35

Phasor Health, LLC

FDA Devices Critical Aug 6, 2025

Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 v…

Hamilton Medical AG

FDA Devices Moderate Aug 6, 2025

Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);

Philips North America

FDA Devices Moderate Aug 6, 2025

Strep Selective II Agar, Product Number R01859

Remel, Inc

FDA Devices Moderate Aug 6, 2025

Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;

Philips North America

FDA Devices Critical Aug 6, 2025

SafeStar 60A Plus Filter. Bidirectionally breathing system filter.

Draeger, Inc.

FDA Devices Moderate Aug 6, 2025

SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;

Philips North America

FDA Devices Moderate Aug 6, 2025

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.

Fresenius Kabi USA, LLC

FDA Devices Moderate Aug 6, 2025

Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions …

Volcano Corp

FDA Devices Moderate Aug 6, 2025

Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 72202…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Aug 6, 2025

HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)

HeartSine Technologies Ltd

FDA Devices Moderate Aug 6, 2025

ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved …

FUJIFILM Healthcare Americas Corporation

FDA Devices Moderate Aug 6, 2025

Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;

Philips North America

FDA Devices Moderate Aug 6, 2025

Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;

Philips North America

FDA Devices Moderate Aug 6, 2025

Intera 3.0T Quasar Dual Model Number (REF): 781150;

Philips North America

FDA Devices Moderate Aug 6, 2025

Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;

Philips North America

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.