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

4726–4750 of 27375

CriticalFDA (Devices)·Z-2442-2024·2024-08-14
Medline Medical Procedure Kits Recalled Due to Defective Plastic Syringes
Medline is recalling over 1.6 million medical procedure kits nationwide and internationally due to plastic syringe defects. The affected kits contain syringes with leaks, breakage, and quality issues that may pose risks to patient health.
Product
Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, Pack Number DYNJRA1268C; 3) WAL- UNIVERSAL BLOCK TRAY, Pack Number DYNJRA1638C; 4) BASIC DIAGNOSTIC TRAY, Pack Number DYNJRA1928; 5) PREOP NERVE BLOCK TRAY
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2446-2024·2024-08-14
Puritan Bennett 500 Series Ventilators recalled due to volatile organic compound release
Covidien recalls 34,642 Puritan Bennett 500 Series Ventilators due to release of volatile organic compound (2-propanol, 1,3-dichloro) from gas pathway components during prolonged use beyond 10 years.
Product
Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560 VENTILATOR EU-DIV/4096600-01, PURITAN BENNETT 560 VENTILATOR JAPAN/4096600-02, PURITAN BENNETT 560 VENTILATOR APAC/4096600-03, Puritan Bennett 560 Ventilat
Category
Medical Device
Distribution
34 states
SevereFDA (Devices)·Z-2419-2024·2024-08-14
CADD-Solis Ambulatory Infusion Pumps with Software Defects Affecting Device Responsiveness
CADD-Solis Model 2100 infusion pumps with pre-v4.3 software have defects affecting occlusion detection and device responsiveness. Manufacturer recommends updating to software version 4.3 (2023) to resolve the issues.
Product
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that re
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2420-2024·2024-08-14
CADD-Solis VIP Ambulatory Infusion Pump Class I Recall
Smiths Medical is recalling CADD-Solis VIP Model 2110 infusion pumps in a Class I action affecting units worldwide.
Product
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of in
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2444-2024·2024-08-14
Medline Procedure Kits Recalled Due to Defective Syringes and Quality Issues
Medline procedure kits containing defective plastic syringes have been recalled due to leaks, breakage, and quality issues that may harm patients. The recall affects over 1.6 million units distributed worldwide.
Product
Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ; 2) VASCULAR PACK , Pack Number CMPJ11455B ; 3) SALEM CATH LAB-LF , Pack Number DYNJ26938J ; 4) EH PEDIATRIC CATH , Pack Number DYNJ49920L ; 5) ARTERIOGRAM PACK, Pack Number DYNJ5
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2421-2024·2024-08-14
Smiths Medical CADD-Solis VIP Ambulatory Infusion Pumps Recalled Worldwide
Smiths Medical is recalling CADD-Solis VIP ambulatory infusion pumps (models 21-2120, 21-2125, 21-2127) worldwide. The FDA has classified this as a Class I recall.
Product
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies t
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2443-2024·2024-08-14
Medline Procedure Kits Recalled Due to Defective Plastic Syringes
Medline procedure kits containing defective plastic syringes are being recalled nationwide. The syringes may leak, break, or have other quality issues that could pose a risk to patient health.
Product
Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE BLOCK TRAY, Pack Number DYNJRA1221A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2516-2024·2024-08-14
Medline Centurion Procedure Kits Recalled for Syringe Leaks, Breakage, and Quality Defects
Medline has recalled Centurion procedure kits containing syringes affected by an FDA safety alert. The syringes may leak, break, or have other quality defects, posing a risk to patient health.
Product
Centurion procedure kits labeled as: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2523-2024·2024-08-14
Biopsy Drape Pack sterilization failure recall from American Contract Systems
American Contract Systems is recalling 224 Biopsy Drape Pack convenience kits due to insufficient aeration time during sterilization, which may have compromised the sterility of affected units. Lot 981241 distributed in CA, KS, ME, MN, MO, NE, and SD is affected.
Product
American Contract Systems Biopsy Drape Pack convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2533-2024·2024-08-14
Verigene Gram Positive Blood Culture Test Recalled for Defective Cartridges
Luminex recalls approximately 1,100 diagnostic kits due to defective test cartridges that may produce false positive results for Staphylococcus lugdunensis and Enterococcus faecium bacteria.
Product
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2474-2024·2024-08-14
SIGNA MR380 MRI system software may exceed implant heating limits
GE SIGNA MR380 MRI systems with software versions SV25.5 or SV25.6 may exceed radiofrequency heating limits during certain imaging sequences, potentially causing MR-conditional implants to overheat. The issue occurs in Low SAR Mode when specific T2 FLAIR sequences are used with the Optimized T2 FLAIR option disabled.
Product
SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2507-2024·2024-08-14
Integra Recalls TruDi NAV Suction Instruments for Calibration Error
Integra LifeSciences has recalled 265 TruDi NAV Suction Instruments due to incorrect calibration. The miscalibrated units may display inaccurate position information during surgical navigation procedures.
Product
TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and skull base surgery
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-2515-2024·2024-08-14
Centurion Procedure Kits with Defective Syringes Recalled Worldwide
Medline Industries is recalling Centurion procedure kits due to defective plastic syringes affected by an FDA safety alert. The syringes may leak or break and pose a potential risk to patient health.
Product
Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2501-2024·2024-08-14
Medication Dispensing Cabinet Software Error Can Print Incorrect Bin Labels
A software error in CareFusion's BD PYXIS automated medication dispensing cabinet can cause incorrect medication bin numbers to be printed on restock labels, risking medication dispensing errors.
Product
BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2532-2024·2024-08-14
FDA Recalls CryoPatch Cardiac Tissue Grafts Due to Invalid Test Results
Artivion has recalled CryoPatch SG cardiac tissue patches used in pulmonary surgeries due to approval and release with invalid test results. Patients who received implants should consult their healthcare provider.
Product
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac Tis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2490-2024·2024-08-14
BD PYXIS automated medication cabinet software defect causes incorrect bin labels
A software defect in BD PYXIS MEDBANK automated medication dispensing cabinets may cause the incorrect medication bin to be printed on restock labels, potentially resulting in medication errors.
Product
BD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2509-2024·2024-08-14
Philips IntelliVue Patient Monitors with disabled monitoring software options
Philips IntelliVue Patient Monitors (MX400/450/500/550) with software versions L.x or M.x lack required monitoring capabilities due to removed software entitlements. The missing features could lead to incorrect or delayed patient treatment.
Product
IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, an
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2511-2024·2024-08-14
Philips IntelliVue Patient Monitors Shipped with Missing Monitoring Capabilities
Philips IntelliVue patient monitors shipped or updated with software that removes monitoring capabilities, potentially delaying or resulting in incorrect treatment.
Product
IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2528-2024·2024-08-14
Multitom Rax X-Ray Systems Support Arm May Lower Unexpectedly
The support arm on Siemens Multitom Rax X-ray systems may unintentionally lower, creating a fall risk to people positioned beneath the ceiling-mounted display during system positioning.
Product
Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 10860700
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2513-2024·2024-08-14
Surgical Staple Reinforcement Devices Recalled for Incorrect Expiration Dating
W.L. Gore & Associates recalled 51 units of GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement due to incorrect expiration date labeling. The devices were labeled with a four-year and ten-day expiration date instead of the validated two-year shelf life.
Product
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2461-2024·2024-08-14
MRI System Software Miscalculation May Overheat Patient Implants
A software error in GE SIGNA Hero MRI systems can cause overheating of MR conditional implants under specific conditions. The recall affects 95 units distributed worldwide.
Product
SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2488-2024·2024-08-14
BD PYXIS Automated Medication Cabinet Software Label Error Affects 11 Units
CareFusion's BD PYXIS medication dispensing cabinet with software version 3.9.1.9 may print incorrect bin labels during restocking, potentially leading to wrong medication dispensing. Eleven units distributed nationwide are affected.
Product
BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2471-2024·2024-08-14
GE SIGNA 1.5T MR Systems May Overheat Implants in Low SAR Mode
GE Medical Systems recalled 2,146 SIGNA 1.5T MR systems that may overheat implants during certain imaging sequences in Low SAR mode due to a software defect in radiofrequency safety calculations.
Product
1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2486-2024·2024-08-14
Automated dispensing cabinet software issue causes incorrect medication bin labels
CareFusion is recalling 232 automated medication dispensing cabinets due to a software issue that may print incorrect medication bin labels, potentially causing medication dispensing errors.
Product
BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2498-2024·2024-08-14
Automated Dispensing Cabinet Software Error May Print Incorrect Medication Bin Labels
CareFusion's BD PYXIS MEDBANK automated dispensing cabinet contains a software flaw that may print incorrect medication bin labels, potentially leading to dispensing of wrong medications.
Product
BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software version 3.9.1.9
Category
Medical Device
Distribution
Distributed nationwide

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4726–4750 of 27375