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

7926–7950 of 27535

HighFDA (Devices)·Z-1431-2025·2025-04-02
Medline Pressure Monitoring Kits Recalled for Luer Fitting Manufacturing Defect
Medline Industries is recalling 1,669 pressure monitoring line convenience kits distributed worldwide. The female luer fittings contain excess material near the fluid pathway.
Product
namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRANS,ST. *, REF 60010511; 3) MTS,LT,HT,KIT-BRYAN,LGH,M.C.,EAST, REF 60020323; 4) MTO,RIGHT,KIT-BRONSON,M* HOSP PG, REF 60020676; 5) MTS,LEFT HEART,KIT-C*,ME
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1425-2025·2025-04-02
Lap Pack Convenience Kits Recalled for Sterility Assurance Concerns
American Contract Systems is recalling 500 Lap Pack - 170307 convenience kits distributed in Arizona due to sterility assurance concerns with procedure trays.
Product
Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A Product Description: Convenience Kit Component: No
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1447-2025·2025-04-02
Medline procedure kits recalled for syringe quality defects
Medline Industries is recalling 1,711 procedure kits containing plastic syringes affected by manufacturing defects. The syringes may leak or break, posing a risk to patient safety during medical procedures.
Product
Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D; 2) CSMC/GYN LAPAROSCOPIC PACK-LF, Pack Number DYNJ0665103I; 3) DAVINCI PACK-RFD, Pack Number DYNJ47762O; 4) DAVINCI ROBOT PACK SLRMC, Pack Number DYNJ81236; 5) GENERAL ROBOTICS PACK, Pack
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0293-2025·2025-04-02
Strides Pharma Testosterone Gel Recalled Due to Benzene Contamination
Strides Pharma is recalling Testosterone Gel 1% (195,952 cartons nationwide) due to benzene contamination. Consumers using affected lots should immediately contact their healthcare provider.
Product
TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1442-2025·2025-04-02
Medline General Endoscopy Procedure Kit Recalled Due to Syringe Defects
Medline is recalling General Endoscopy procedure kits due to plastic syringe defects that may leak or break. The affected kits pose potential risk to patient health during medical procedures.
Product
Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1419-2025·2025-04-02
Baxter TruSystem 7500 Software Issue Impairs Upper Back Adjustment in Emergency Mode
Baxter Healthcare is recalling 93 TruSystem 7500 Hybrid Plus units for a software issue that renders the upper back section inoperable when emergency mode is enabled.
Product
Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1463-2025·2025-04-02
Medline medical procedure kits recalled for plastic syringe defects
Medline procedure kits with plastic syringes are being recalled due to potential leaks and breakage that may affect patient safety. The recall impacts 1152 units distributed nationwide and in Canada.
Product
Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1438-2025·2025-04-02
Medline Surgical Procedure Kits Recalled for Defective Plastic Syringes
Medline Industries recalls 3,860 surgical procedure kits with defective plastic syringes that may leak or break during use. The affected kits are distributed in the US and Canada.
Product
Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J; 3) CABG, Pack Number DYNJ906462B; 4) CABG ACCESSORY PACK-LF, Pack Number DYNJ0261346U; 5) CARDIAC CATH PACEMAKER-LF, Pack Number DYNJ42997C;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0294-2025·2025-04-02
Testosterone Gel Recalled Nationwide Due to Benzene Contamination
Strides Pharma is recalling Testosterone Gel 1% nationwide due to the presence of benzene, a toxic substance. Patients should contact their healthcare provider about alternative treatment options.
Product
TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1449-2025·2025-04-02
Medline Procedure Kits With Defective Syringes Recalled Nationwide
Medline is recalling 268 procedure kits nationwide due to plastic syringes affected by a March 2024 FDA safety alert. The syringes may leak, break, or have quality issues that could affect patient care.
Product
Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D; 3) ROBOT LAP TOTAL HYST, Pack Number DYNJ907811A; 4) VAG HYSTE PACK-LF, Pack Number DYNJ0773613J; 5) VAG HYSTERECTOMY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1467-2025·2025-04-02
Checkpoint Guardian Intraoperative Lead: Potential Electrical Exposure Risk
Adhesive may not fully encapsulate metallic components on Checkpoint Guardian Intraoperative Leads, creating potential for electrical current leakage. This could cause inconsistent muscle responses and incorrect surgical actions.
Product
Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Model/Catalog Number: REF# 9525 (Medium) Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1450-2025·2025-04-02
Medline Medical Procedure Kits With Plastic Syringes Recalled for Quality Issues
Medline medical procedure kits containing plastic syringes are being recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health.
Product
Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN CYSTO, Pack Number DYNJ61371A; 3) OB PACK-LF, Pack Number DYNJ20720C; 4) PELVISCOPY PACK-LF, Pack Number DYNJ0415776N; 5) POSTERIOR EYE PACK-LF, Pack Number PHS656483I; 6) ROBOTICS PA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0303-2025·2025-04-02
Sodium Bicarbonate Injection Recalled Due to Sterility Assurance Issue
Exela Pharma Sciences is recalling Sodium Bicarbonate 8.4% Injection due to lack of sterility assurance. The recall affects approximately 103,950 vials nationwide.
Product
SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1439-2025·2025-04-02
Medline Procedure Kits With Defective Plastic Syringes Recalled
Medline is recalling surgical procedure kits with plastic syringes affected by a March 2024 FDA Safety Alert due to leaks, breakage, and quality issues that may pose risks to patients.
Product
Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNEE, Pack Number DYNJ56717A; 3) CVL INSERTION PACK, Pack Number CVI5065; 4) KT DR VELASCO FISTULA PACK, Pack Number DYNJ46648D; 5) PICC ABSCESS PACK-LF, Pac
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1408-2025·2025-04-02
Premier Solo Diamond dental burs recalled due to material hardness defect
Premier Dental Products Co is recalling Premier Solo Diamond Large dental burs because the material hardness does not meet specifications and may cause the burs to bend during use. 77 units in six U.S. states are affected.
Product
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1451-2025·2025-04-02
Medline Procedure Kits with Defective Plastic Syringes Recalled for Safety
Medline is recalling medical procedure kits containing plastic syringes with quality defects including leaks and breakage that may pose a risk to patient health. The recall affects 5,132 units distributed nationwide and in Canada.
Product
Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V; 2) CATARACT CM-LF, Pack Number DYNJ39921B; 3) CATARACT EYE, Pack Number DYNJ45662C; 4) CATARACT PACK, Pack Number DYNJ56056B; 5) CATARACT PACK, Pack Number DYNJ56553B; 6) CATARACT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1460-2025·2025-04-02
Medline ReNewal Electrophysiology Catheters Recalled for Elevated Bacterial Endotoxin Levels
Medline is recalling ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters used in cardiac procedures because the devices may contain higher than expected levels of bacterial endotoxin.
Product
Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0297-2025·2025-04-02
Compounded Fentanyl-Ropivacaine Epidural Injection Recalled Due to Sterility Assurance Concerns
QuVa Pharma is recalling 1,765 cassettes of compounded epidural injection due to lack of sterility assurance. The affected lots were distributed nationwide to institutional and office locations.
Product
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Su
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1445-2025·2025-04-02
Medline Laceration Tray Procedure Kits Recalled for Syringe Defects
Medline procedure kits containing plastic syringes affected by an FDA safety alert are being recalled. The syringes may leak or break, posing a potential risk to patient health.
Product
Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1427-2025·2025-04-02
CardioMEMS Heart Failure Monitoring System Recalled for Data Migration Issues
St. Jude Medical is recalling the CardioMEMS Heart Failure System due to data migration issues resulting in duplicated or missing patient information.
Product
CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000 The CardioMEMS" HF System provides pulmonary art
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1454-2025·2025-04-02
Helix Elite Quality Control Material Recalled for Delayed Detection and QC Failure
Microbiologics Inc is recalling its Helix Elite RSV quality control material (Lot HE0044-131) because the RSV component may produce delayed test results and could fail quality control checks. This Class II recall affects 28 units distributed worldwide.
Product
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1426-2025·2025-04-02
Cardiac catheterization kit recalled due to sterility concerns
American Contract Systems recalls 460 Cardiac Cath Lab Pack kits due to sterility assurance issues with procedure trays. Facilities should verify affected lots have been removed from clinical use.
Product
Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A Product Description: Convenience Kit Component: No
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1416-2025·2025-04-02
Baxter TruSystem 7500 Hybrid medical device software defect in emergency mode
Baxter is recalling 2 units of TruSystem 7500 Hybrid (MC) due to a software issue that disables the upper back section adjustment when emergency mode is activated.
Product
Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1413-2025·2025-04-02
Baxter Mobile column TruSystem 7500 U emergency mode software issue affects back adjustment
A software issue in the Baxter Mobile column TruSystem 7500 U prevents the upper back section from being operable or adjustable when emergency mode is enabled. Approximately 40 units distributed nationwide are affected.
Product
Baxter Mobile column TruSystem 7500 U, Product Code 1730720
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1414-2025·2025-04-02
Baxter TruSystem 7500 U Medical Device Software Malfunction Recall
Baxter is recalling the Stationary column TruSystem 7500 U due to a software issue that prevents the upper back section from being adjustable when emergency mode is enabled.
Product
Baxter Stationary column TruSystem 7500 U, Product Code 1730731
Category
Medical Device
Distribution
Distributed nationwide

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7926–7950 of 27535