Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

4026–4050 of 39948

HighFDA (Devices)·Z-1672-2025·2025-05-07
Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer Recall
Beckman Coulter is recalling certain DxC 500 AU Clinical Chemistry Analyzers due to incorrect sample barcode identification and processing errors that can result in erroneous and delayed test results.
Product
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that meas
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1686-2025·2025-05-07
IceSeed 1.5 CX S Cryoablation Needle Programmed with Incorrect Settings
Boston Scientific is recalling 435 IceSeed 1.5 CX S cryoablation needles manufactured between April 2024 and February 2025 that were programmed with DEMO settings instead of Commercial settings, which can cause the Cryoablation System to prompt repeated tests if the needle is disconnected and reconnected.
Product
IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1709-2025·2025-05-07
Medline Sterile Water and Saline Bottles Recalled for Leaking Seals
Medline Industries is recalling Sterile Water and Sterile 0.9% Normal Saline bottles due to leaking at the peel-foil and bottle opening interface. The affected kits were distributed nationwide and internationally.
Product
Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL TRAY, REF DYNDC1311C; 4) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185; 5) NURSING SKILLS, REF EDUC05015A; 6) NURSING SUPPLY BAG, REF EDUC102
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1689-2025·2025-05-07
IceSeed 1.5 CX Cryoablation Needles Recalled for Incorrect Software Settings
Boston Scientific is recalling IceSeed 1.5 CX cryoablation needles manufactured between April 2024 and February 2025 due to incorrect software programming. Affected needles may prompt unnecessary Needle Integrity and Functionality Tests if disconnected and reconnected during use.
Product
IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1692-2025·2025-05-07
Defibtech Automated External Defibrillators Model DDU-2300 Recalled
Defibtech is recalling Automated External Defibrillators Model DDU-2300 distributed in Switzerland because Italian-language labeling and instructions were not included, violating Swiss Medical Devices Ordinance requirements.
Product
Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1¿(German/English dual language), DCF-E2310E3/1¿(German/French dual language), DCF-E2310F3/1¿ (French/English dual language), DCF-E2310G3/1¿(French/German dual language), DCF-E2310IT (Italian language)
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1674-2025·2025-05-07
Hyperthermia Pump Procedure Kit Recalled for Cracked Connector
Belmont Instrument LLC is recalling 158 Hyperthermia Pump Procedure Kits (Model 902-00045) due to a potential crack in the female connector on the Heat Exchanger set that may cause fluid leakage during use.
Product
Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Hyperthermia Procedure kit (P/N 902-00045) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and HP Procedu
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1685-2025·2025-05-07
epoc BGEM Crea Test Card for Blood Analysis System recalled
Siemens Healthcare Diagnostics is recalling epoc BGEM Crea Test Card (25 pk) units due to discrepant high pH results in samples with higher injection volumes. The recall affects 5,207 units distributed nationwide and internationally.
Product
epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1688-2025·2025-05-07
IceSeed CX Cryoablation Needles Recalled for Demo Programming Issue
Boston Scientific is recalling IceSeed 1.5 CX cryoablation needles manufactured between April 2024 and February 2025 because they were programmed with demo settings instead of commercial settings. If disconnected and reconnected during use, the system will prompt unnecessary recalibration testing.
Product
IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1715-2025·2025-05-07
Olympus SOLTIVE Pro SuperPulsed Laser System procedural parameter issue
Olympus is recalling the SOLTIVE Pro SuperPulsed Laser System because preset treatment parameters may not be consistently applied according to the instructions for use.
Product
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and poten
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1683-2025·2025-05-07
HistoCore PELORIS 3 Rapid Tissue Processor Manifold Tubing Leakage
Leica Biosystems is recalling 77 units of the HistoCore PELORIS 3 Rapid Tissue Processor due to a leakage issue in the manifold tubing. The affected units were distributed across 14 US states.
Product
HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1708-2025·2025-05-07
Medline Non Sterile I&D Kit Procedure Kits Recalled for Leaking Bottles
Medline Industries is recalling Non Sterile I&D Kit procedure kits (Lot 23KDB283) because Sterile Water and Sterile 0.9% Normal Saline bottles leak at the peel-foil and bottle opening interface. The kits were distributed worldwide, including the US, Panama, and Canada.
Product
Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1676-2025·2025-05-07
Belmont Hyperthermia Pump Line Kit Heat Exchanger Connector Crack Recall
Belmont Instrument is recalling the Straight Inflow/Bifurcated Outflow Line Kit (Model 902-00038) due to potential cracks in the female connector on the Heat Exchanger set, which may cause fluid leaks during priming.
Product
Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00038) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1713-2025·2025-05-07
Medline Sterile Water and Saline Bottles Recalled for Leaking
Medline Industries is recalling Sterile Water and Sterile 0.9% Normal Saline bottles due to leaking at the peel-foil and bottle opening interface. The affected kits were distributed nationwide and internationally.
Product
Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1661-2025·2025-05-07
Trimble RTS873 Robotic Total Station Green Laser Safety Issue
Trimble is recalling 127 RTS873 robotic total stations because the green aiming laser output power may exceed its Class 2 laser safety classification. Units were produced between October 2023 and February 12, 2025 and distributed in the US, South Korea, and United Kingdom.
Product
The Trimble RTS873 robotic total station is a solution designed for construction professionals seeking precision, efficiency, and reliability in their layout tasks. The integrated Class 2 green aiming laser system enhances visibility and accuracy, even on uneven surfaces. It is i
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1693-2025·2025-05-07
Automated External Defibrillator Model DDU-2450 Missing Italian Translation
Defibtech, LLC is recalling one Automated External Defibrillator Model DDU-2450 (German language version) distributed in Switzerland because it lacks required Italian language labeling and instructions for use.
Product
Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1712-2025·2025-05-07
Medline Sterile Water and Saline Bottles Recalled for Leaking Peel-Foil Seals
Medline procedure kits containing Sterile Water and Sterile 0.9% Normal Saline bottles are being recalled because the bottles leak at the peel-foil and bottle opening interface.
Product
Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1707-2025·2025-05-07
Medline procedure kits recalled for leaking sterile water and saline bottles
Medline procedure kits containing sterile water and 0.9% normal saline bottles are being recalled because the bottles leak at the peel-foil and bottle opening interface. The kits were distributed worldwide including the US, Panama, and Canada.
Product
Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1706-2025·2025-05-07
Medline Sterile 0.9% Normal Saline 100mL bottles recalled for leaks
Medline Sterile 0.9% Normal Saline 100mL bottles are being recalled because they may leak at the interface where the peel-foil meets the bottle opening. The bottles were distributed nationwide in the US and in Panama and Canada.
Product
Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1703-2025·2025-05-07
myQA iON dosimetry device analysis result miscalculation issue
IBA Dosimetry GmbH is recalling the myQA iON dosimetry device (Article Number MQ10-000) because creating two structures with identical names except for a special character causes wrong analysis results.
Product
myQA iON; Article Number: MQ10-000;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1705-2025·2025-05-07
Medline Sterile Water USP bottles recalled for leaking at peel-foil interface
Medline Sterile Water, USP 100mL bottles are being recalled because they leak at the interface between the peel-foil and bottle opening, posing a contamination risk.
Product
Medline Sterile Water, USP, 100mL, REF RDI30295
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1687-2025·2025-05-07
Boston Scientific IceSeed CX Cryoablation Needles Incorrectly Programmed
Boston Scientific is recalling IceSeed 1.5 CX S cryoablation needles manufactured April 2024 to February 2025 that were programmed with DEMO instead of Commercial settings. If disconnected and reconnected after initial testing, the system will re-prompt testing rather than functioning normally.
Product
IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1710-2025·2025-05-07
Medline Plastics Suture Tray recalled due to leaking sterile liquid bottles
Medline is recalling Plastics Suture Tray kits (Ref SUT13535) because the included Sterile Water and Sterile 0.9% Normal Saline bottles leak at the peel-foil and bottle opening interface.
Product
Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1691-2025·2025-05-07
Automated External Defibrillators DDU-2200 Missing Italian Language Translation
Defibtech is recalling Automated External Defibrillators Model DDU-2200 distributed in Switzerland because they lack required Italian language labeling and instructions for use.
Product
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1694-2025·2025-05-07
Defibtech Automated External Defibrillators Model DDU-2200 Missing Italian Translation
Defibtech is recalling Automated External Defibrillators Model DDU-2200 distributed in Switzerland due to missing Italian translation of product labeling and instructions, which violates Swiss Medical Devices Ordinance requirements.
Product
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1690-2025·2025-05-07
Semi-Automated External Defibrillators Missing Italian Language Labeling
Defibtech is recalling semi-automated external defibrillators (Models DDU-100 and DDU-100E) distributed in Switzerland because they lack required Italian language labeling and instructions for use.
Product
Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language)
Category
Medical Device
Distribution
0 states

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4026–4050 of 39948