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

3476–3500 of 13449

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-1461-2025·2025-04-02
Medline Procedure Kits Recalled for Syringe Leaks and Breakage
Medline Industries is recalling 2,161 medical procedure kits containing plastic syringes with leaks and breakage issues. The affected syringes pose a potential risk to patient health and are distributed in the US and Canada.
Product
Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C; 2) BLEPH/RHINO PACK, Pack Number DYNJ64669A; 3) DB ENT CSTM PACK-LF, Pack Number DYNJ33585C; 4) DENTAL PACK, Pack Number DYNJ54064; 5) EAR PACK, Pack Number DYNJ68678C; 6) EN
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-1409-2025·2025-04-02
Baxter Operating Table Column Software Issue Limits Emergency Mode Function
Baxter Healthcare is recalling 403 TS7500 MOBIUS operating table columns due to a software issue that prevents the upper back section from being adjustable when emergency mode is activated.
Product
Baxter Operating table column TS7500 MOBIUS, Product Code 1704695
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-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-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-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-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-1455-2025·2025-04-02
Contact lenses for astigmatism recalled due to incorrect cylinder power
CooperVision is recalling multiple brands of daily disposable toric contact lenses manufactured with incorrect cylinder power in certain lot codes. Users of affected lenses should stop wearing them and contact their eye care provider.
Product
Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Day Premium For Astigmatism, REVEAL 1-DAY TORIC, Vision Source Reveal Toric, Voyant 1-Day Premium Toric. Brand Names (OUS only): CADENCE DELUXE 1-DAY TORIC, DUB
Category
Medical Device
Distribution
15 states
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-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-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-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-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-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
HighFDA (Devices)·Z-1421-2025·2025-04-02
Baxter TruSystem 7500 Hybrid IMRIS Upper Back Adjustment Software Malfunction
A software issue in the Baxter TruSystem 7500 Hybrid MR IMRIS system prevents the upper back section from being adjusted when emergency mode is enabled. The recall affects 24 units distributed nationwide.
Product
Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1417-2025·2025-04-02
Baxter TruSystem 7500 Hybrid software issue disables upper back adjustment
Baxter TruSystem 7500 Hybrid affected by software issue that prevents the upper back section from being operable or adjustable when emergency mode is enabled. Affects 10 units distributed nationwide.
Product
Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085
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-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-1415-2025·2025-04-02
Baxter Floor Mounting Column TS 7500 U Software Issue Affects Emergency Function
Baxter is recalling 33 units of the Floor Mounting Column TS 7500 U due to a software defect that prevents upper back adjustment when emergency mode is enabled.
Product
Baxter Floor mounting column TS 7500 U, Product Code 1730732
Category
Medical Device
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-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 (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-1437-2025·2025-04-02
Medline Procedure Kits Recalled Due to Defective Plastic Syringe Quality Issues
Medline is recalling 9,246 units of medical procedure kits containing defective plastic syringes with leaks and breakage that may pose a risk to patient health. The kits were distributed nationwide in the US and in Canada.
Product
Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D; 2) ANGIO PACK, Pack Number DYNJ69678; 3) ANGIOGRAPHY CV RAD PACK, Pack Number DYNJ64936A; 4) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ49621C; 5) ANGIOGRAPHY PACK, Pack Number DYNJ
Category
Medical Device
Distribution
Distributed nationwide

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3476–3500 of 13449