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

3551–3575 of 13526

HighFDA (Devices)·Z-1435-2025·2025-04-02
Medline procedure kits with plastic syringes recalled for leaks and breakage
Medline procedure kits containing plastic syringes are recalled for leaks, breakage, and other quality defects identified in an FDA Safety Alert. The recall affects 340 units distributed nationwide in the US and Canada.
Product
Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2) PAIN MANAGEMENT TRAY-LF, Pack Number DYNJRA1749
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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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
ModerateFDA (Devices)·Z-1412-2025·2025-04-02
Baxter Mobile Column TruSystem 7500 Software Defect Prevents Back Adjustment
Baxter Healthcare is recalling the Mobile column TruSystem 7500 due to a software issue that prevents the upper back section from being adjusted when emergency mode is enabled. Approximately 1,596 units distributed nationwide are affected.
Product
Baxter Mobile column TruSystem 7500, Product Code 1717023
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1434-2025·2025-04-02
Prelude IDEAL 4F Hydrophilic Sheath Introducer contains incorrect 5F dilators
Merit Medical Systems is recalling Prelude IDEAL 4F Hydrophilic Sheath Introducer units (Lot H3082668) that contain 5F dilators instead of the labeled 4F dilators, which may result in procedure delay.
Product
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1432-2025·2025-04-02
Orthofix Pillar SA Ti Spacer System Mislabeled for Anterior Height
Orthofix is recalling Pillar SA Ti Spacer System spinal implants because the product label lists an incorrect anterior height of 10mm, while the actual device measures 10.5mm. This labeling discrepancy could affect surgical planning during implantation.
Product
Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees; (2) REF 82-3700SP, 37mm W x 28mm D x 10mm H, 7 degrees; and (3) REF 82-4000SP, 40mm W x 32mm D x 10mm
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1433-2025·2025-04-02
NexGen LPS Flex knee prosthesis recalled for labeling inconsistency
Zimmer recalls 76 NexGen LPS Flex knee prosthesis units due to conflicting plate compatibility information on the product label.
Product
NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1284-2025·2025-03-26
Smiths Medical ProPort Venous Access System Recalled for Port Separation Risk
Smiths Medical is recalling ProPort Plastic Venous Access Systems due to a manufacturing defect that can cause the port housing and reservoir to separate. This may result in device failure affecting patients worldwide.
Product
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1281-2025·2025-03-26
Smiths Medical ProPort Implantable Port Risk of Component Separation
Smiths Medical is recalling its ProPort Plastic Implantable Ports due to a manufacturing defect that may cause the port housing and reservoir to separate, potentially compromising device function.
Product
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24
Category
Medical Device
Distribution
0 states

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3551–3575 of 13526