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

2876–2900 of 27375

HighFDA (Devices)·Z-1446-2025·2025-04-02
Medline Delivery and Labor Kits Recalled for Defective Plastic Syringes
Medline is recalling 1,958 delivery and labor procedure kits containing plastic syringes with leaks, breakage, and quality defects that may pose a risk to patient health.
Product
Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2) DELIVERY PACK-LF, Pack Number DYNJ0968863M; 3) L & D PACK-LF, Pack Number DYNJ0373290N; 4) L&D PACK, Pack Number DYNJ51998A; 5) LABOR & DELIVERY PACK-LF, Pack Number DYNJ0348455P; 6) LAB
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1420-2025·2025-04-02
Baxter TruSystem 7500 Hybrid Plus software issue affects emergency mode operation
Baxter is recalling 48 TruSystem 7500 Hybrid Plus units due to a software issue that prevents the upper back section from being adjusted when emergency mode is enabled.
Product
Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1466-2025·2025-04-02
Checkpoint Guardian Intraoperative Lead adhesive defect electrical leakage risk
The adhesive on Checkpoint Guardian Intraoperative Leads may not fully cover metallic wire components, leading to potential electrical current leakage. This could result in inconsistent muscle responses and affect surgical effectiveness.
Product
Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small Model/Catalog Number: REF# 9524 (Small) Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1429-2025·2025-04-02
Medline Arterial Pressure Monitoring Line Kits Recalled for Manufacturing Defect
Medline is recalling certain arterial pressure monitoring line kits due to excess material on female luer fittings. The affected kits were distributed worldwide, including the United States.
Product
namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1418-2025·2025-04-02
Baxter TruSystem 7500 Hybrid: Software Issue Disables Back Adjustment
Baxter is recalling the TruSystem 7500 Hybrid due to a software issue that prevents the upper back section from being adjustable when emergency mode is enabled.
Product
Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1441-2025·2025-04-02
Medline Surgical Procedure Kits Recalled for Syringe Leakage and Breakage
Medline Industries has recalled 11,774 surgical procedure kits with defective plastic syringes that may leak or break. The kits were distributed nationwide and in Canada.
Product
Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH LAPAROSCOPIC GB PACK, Pack Number DYNJ67756A; 3) CHRISTUS WH LAP CHOLE PACK, Pack Number DYNJ60934B 4) CRMC LAP CHOLE DIAG LAP-LF, Pack Number DYNJ61095D; 5) CYSTO PACK, Pack Number DYNJ
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1464-2025·2025-04-02
Medline Procedure Kits Recalled for Syringe Quality Defects
Medline procedure kits with defective plastic syringes have been recalled due to leaks, breakage, and quality issues that may pose a risk to patient health. The recall involves 422 units distributed in the US and Canada.
Product
Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B; 2) ANGIOGRAPHY PACK, Pack Number DYNJ21519W; 3) NEURO ANGIO PACK, Pack Number DYNJ83941; 4) NEURO ANGIO PACK SJF-LF, Pack Number DYNJ55678; 5) NEURO PACK, Pack Number DYNJ04851Q;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1465-2025·2025-04-02
Medline procedure kits with defective plastic syringes recalled due to leak and breakage risk
Medline procedure kits containing plastic syringes are being recalled due to leaks, breakage, and quality issues that may compromise sterile medical procedures. Approximately 14,589 units were distributed nationwide in the US and Canada.
Product
Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRAM PACK, Pack Number DYNJ64332; 3) ARTHRO PACK-LF, Pack Number DYNJ38748F; 4) ARTHRO PACK-LF, Pack Number DYNJ38748F; 5) ARTHROGRAM PACK, Pack Number DYNJ65817; 6) ARTHROGRAM TR
Category
Medical Device
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-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-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-1443-2025·2025-04-02
Medline CV Neonatal Procedure Kits Recalled Due to Syringe Quality Issues
Medline is recalling CV Neonatal Pack procedure kits (Pack Number DYNJ67356) because the plastic syringes may leak or break, potentially harming patients. The recall affects 96 units distributed nationwide and in Canada.
Product
Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356
Category
Medical Device
Distribution
Distributed nationwide
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-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 (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-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-1440-2025·2025-04-02
Medline Procedure Kits Recalled for Defective Syringes Posing Patient Risk
Medline is recalling 808 medical procedure kits containing plastic syringes with quality defects that may leak or break during use. Affected customers should stop using these kits and contact Medline for replacement instructions.
Product
Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C P PACK, Pack Number DYNJ44115A; 3) LARGE BIOPSY PACK NTX, Pack Number DYNJ68393A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1430-2025·2025-04-02
Pressure Monitoring Lines Recalled for Manufacturing Defect in Luer Fittings
Medline Industries is recalling namic medical convenience kits containing Pressure Monitoring Lines with defective female luer fittings manufactured with excess material. The defect could impair device function.
Product
namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710
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 (Devices)·Z-1436-2025·2025-04-02
Medline Procedure Kits Recalled Due to Defective Plastic Syringes
Medline is recalling angiography and catheterization procedure kits containing plastic syringes that may leak or break. The recalled kits affect 1939 units distributed nationwide and in Canada.
Product
Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK, Pack Number DYNJ30501F; 3) ANGIO PACK-LF, Pack Number DYNJ0954970G; 4) ANGIOGRAPHY 6 FRENCH PACK, Pack Number DYNJ33597J; 5) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ38120B; 6) AN
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1428-2025·2025-04-02
Medline Namic Convenience Kits Pressure Monitoring Lines Recalled for Manufacturing Defect
Medline is recalling 4400 Namic convenience kits with Pressure Monitoring Lines because the female luer fittings were manufactured with excess material near the fluid pathway.
Product
namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
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-1410-2025·2025-04-02
Baxter TruSystem 7500 Stationary Column Recalled for Software Emergency Mode Defect
Baxter Healthcare is recalling 462 units of the TruSystem 7500 Stationary column 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, Product Code 1717020
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1424-2025·2025-04-02
Cysto Pack Procedure Trays Recalled Due to Sterility Assurance Issues
American Contract Systems, Inc. is recalling 800 units of Cysto Pack procedure trays (Model BHCY31E) distributed in Arizona due to sterility assurance concerns.
Product
Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No
Category
Medical Device
Distribution
1 state
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

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2876–2900 of 27375