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.

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2126–2150 of 13382

HighFDA (Devices)·Z-0189-2026·2025-10-22
Baxter IV infusion sets recalled for potential leakage risk
Baxter Healthcare is recalling approximately 49,200 CONTINU-FLO Solution Sets nationwide due to potential leakage in IV infusion tubing. The voluntary recall affects two specific lot numbers.
Product
CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code 2C6255
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0197-2026·2025-10-22
Baxter CLEARLINK IV Extension Sets Recalled for Leak Risk
Baxter Healthcare is recalling 15,552 IV extension sets that may leak during use. The voluntary recall affects units distributed nationwide; no injuries reported.
Product
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0170-2026·2025-10-22
Medical biopsy tray recalled due to unvalidated sterilization process
American Contract Systems is recalling 32,433 Basic Biopsy Trays because they were re-sterilized without proper validation, compromising product safety and effectiveness.
Product
Basic Biopsy Tray, Item Number NMBP44L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0200-2026·2025-10-22
IV Extension Sets Recalled for Potential Leakage
Baxter Healthcare is recalling CLEARLINK System Non_DEHP Extension Sets due to potential leakage in the IV sets. The voluntary recall affects products distributed nationwide.
Product
CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19-inch (47 centimeters), Product Code 2H8603
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0035-2026·2025-10-15
BD Alaris Pump Infusion Sets May Deliver Inaccurate Doses
BD Alaris Pump Infusion Sets may operate outside established performance ranges for flow rate, bolus accuracy, and occlusion detection, potentially delivering incorrect medication doses to patients receiving intravenous therapy.
Product
BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10015414, 180 Micron Filter 2447-0007, Ball Valve SmartSite Port (Burette) 2 SmartSites Y-Sites 24201-0007, 2 SmartSite Y-sites
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0069-2026·2025-10-15
Heart pump controller recalled for operating system cybersecurity vulnerabilities
Abiomed is recalling Automated Impella Controller (AIC) devices due to potential cybersecurity vulnerabilities in the operating system. Approximately 10,153 units have been distributed nationwide and internationally.
Product
Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0028-2026·2025-10-15
NOxBOXi Nitric Oxide Delivery System may cause dose fluctuations under specific conditions
NOxBOXi Nitric Oxide Delivery Systems may experience dose fluctuations when operating at certain parameters, potentially affecting treatment reliability. The FDA issued a Class I recall affecting 1,667 units.
Product
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0029-2026·2025-10-15
NOxBOXi Nitric Oxide Delivery System Software Malfunction Recall
NOXBOX LTD is recalling 1,667 units of the NOxBOXi Nitric Oxide Delivery System (Model NOXBOX-I) due to a software fault causing unexpected system errors when multiple buttons are pressed rapidly. The FDA classified this as a Class I recall due to potential device malfunction risk.
Product
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0119-2026·2025-10-15
Epidural Catheter Tray: Connector Lid Positioning Defect
B. Braun Medical is recalling PERIFIX FX Continuous Epidural Anesthesia Trays due to a potential defect where the catheter connector lid may be positioned incorrectly. The recall affects 21,270 units distributed nationwide.
Product
PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFCS. Product Description: CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0124-2026·2025-10-15
Design Options Pain Management Trays Recalled for Connector Lid Malposition
B. Braun Medical Inc. is recalling Design Options Pain Management Trays because the catheter connector lid may be positioned incorrectly, affecting spinal and epidural anesthesia delivery.
Product
Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY. 2. SESK OWENSBORO DAVIESS HOSP 20058814. 3. SESK MEMORIAL HEALTH SYSTEM SPINAL/EPID. 4. SESK ST. JOHN'S MERCY MED CTR SPINAL/EPID. 5. SESK MAIMONI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0127-2026·2025-10-15
Nasal feeding tubes recalled for distal tip detachment risk
Applied Medical Technology is recalling 1,780 NutraGlide nasal feeding tubes because distal tips may detach at lower than expected forces. The affected tubes were distributed to Massachusetts and Rhode Island.
Product
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0128-2026·2025-10-15
NutraGlide Nasal Feeding Tube recalled due to detachable distal tips
Applied Medical Technology is recalling NutraGlide Nasal Feeding Tubes because the distal tips may detach at lower than expected forces. The tubes are used for nutrition and medication administration in neonatal, pediatric, and adult patients.
Product
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 90, REF E NRT-05090-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0037-2026·2025-10-15
Canon Medical Digital Radiography System SPOT Fluoro Display Obstruction
Canon Medical's diagnostic fluoroscopy systems have a software issue where the SPOT Fluoro function can obstruct the diagnostic image display when the acquisition program is changed, partially covering the collimated imaging area with a static overlay.
Product
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0116-2026·2025-10-15
PERIFIX FX Epidural Anesthesia Tray Connector Lid Misalignment Recall
B. Braun is recalling 48,110 units of PERIFIX FX Continuous Epidural Anesthesia Trays because the catheter connector lid may be positioned incorrectly, potentially affecting proper catheter function during procedures.
Product
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFC. Product Description: CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0125-2026·2025-10-15
Combined Spinal and Epidural Anesthesia Tray Recalled for Connector Lid Defect
B. Braun Medical is recalling 60 units of a Combined Spinal and Epidural Anesthesia Tray because the catheter connector lid may be positioned incorrectly. Affected units were distributed nationwide.
Product
Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Product Code: SESK. Product Description: SESK COMBINED SPINAL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0115-2026·2025-10-15
PERIFIX FX Epidural Anesthesia Tray Catheter Connector Lid Positioning Defect
B BRAUN Medical is recalling PERIFIX FX Continuous Epidural Anesthesia Trays due to a potential manufacturing defect where the catheter connector lid may be positioned incorrectly, which could affect proper drug delivery and catheter function.
Product
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFCPS. Product Description: CE17TKFCPS EPIDURAL FULL TRAY.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0126-2026·2025-10-15
PERIFIX FX Epidural Anesthesia Tray Catheter Connector Lid Position Defect Recall
B. Braun Medical is recalling 5,770 Design Options PERIFIX FX Epidural Anesthesia Trays due to a potential defect where the catheter connector lid may be positioned incorrectly. The recall affects units distributed nationwide.
Product
Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: 1. CESK ROBERT WOOD JOHNSON UNIV HOSP. 2. CESK EAST JEFFERSON GEN HOSP 20071769. 3. CESK FLETCHER ALLEN HOSPITAL. 4. CESK WASHOE MEDICAL CENTER. 5. CESK DETROIT MEDI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0122-2026·2025-10-15
ESPOCAN Spinal-Epidural Anesthesia Tray Recalled for Catheter Connector Positioning Defect
B. Braun Medical Inc. recalls ESPOCAN Combined Spinal and Epidural Anesthesia Trays nationwide due to potential catheter connector lid misalignment that could affect anesthetic administration.
Product
ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 25 Ga. x 5 in. (12.7 cm) Spinal Needle with Marking and Centering Sleeve, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Product Code: ES1725KF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0123-2026·2025-10-15
Combined Spinal and Epidural Anesthesia Tray Catheter Connector Positioning Defect
B. Braun is recalling 2,840 units of its Combined Spinal and Epidural Anesthesia Tray because the catheter connector lid may be positioned incorrectly, potentially affecting device function.
Product
Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle and 19 Ga. Open Tip PERIFIX FX Springwound Epidural Catheter. Product Code: NES1727KFX. Product Description: NES1727KFX W /17GA T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0044-2026·2025-10-15
X-ray imaging equipment recalled for potentially defective mounting shaft
FUJIFILM Healthcare's FDR Visionary Suite X-ray equipment may have a defective mounting shaft that can break, potentially compromising protective equipment functionality. Sixteen units were distributed across eight states.
Product
FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0130-2026·2025-10-15
NutraGlide Nasal Feeding Tubes Recalled for Distal Tip Detachment Risk
Applied Medical Technology is recalling NutraGlide Nasal Feeding Tubes because the distal tip may detach at lower than expected forces. The recall affects 200 units distributed in Massachusetts and Rhode Island.
Product
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 90, REF E NRT-06090-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0121-2026·2025-10-15
PERIFIX FX Epidural Anesthesia Sets Recalled Due to Catheter Connector Positioning Defect
B. Braun Medical recalls PERIFIX FX Continuous Epidural Anesthesia Sets due to a potential defect where the catheter connector lid may be positioned incorrectly.
Product
PERIFIX FX Continuous Epidural Anesthesia Set, PERIFIX Tuohy Epidural Needle - 17 Ga. x 3-1/2 in. (8.9 cm) - Winged, PERIFIX FX Springwound Epidural Catheter - 19 Ga. Closed tip. Product Code: CE17TFC. Product Description: CE17TFC CONTINUOUS EPID SET W/17G TUOHY.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0068-2026·2025-10-15
GE Medical Systems AW Server Security Vulnerability Affecting Patient Data
GE Medical Systems has recalled AW Server 2.0, 3.0, 3.1, and 3.2 due to a security vulnerability that could allow malicious actors to compromise patient data confidentiality, integrity, and availability. No patient harm has been reported.
Product
AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0039-2026·2025-10-15
CorNeat EverPatch Surgical Matrix Recalled for Potential Early Tissue Exposure
CorNeat EverPatch surgical patches are recalled due to risk of early exposure caused by conjunctival wound separation. The FDA identified the issue through complaint review.
Product
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0129-2026·2025-10-15
NutraGlide Nasal Feeding Tubes recalled due to distal tip detachment risk
Applied Medical Technology is recalling 840 units of NutraGlide Nasal Feeding Tubes distributed in Massachusetts and Rhode Island because the distal tips may detach at lower than expected forces.
Product
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal
Category
Medical Device
Distribution
2 states

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2126–2150 of 13382