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

5601–5625 of 13543

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-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-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-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-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-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-2518-2024·2024-08-14
Gyn Laparoscopy Kits Recalled Due to Inadequate Sterilization Process
American Contract Systems is recalling 29 gynecological laparoscopy surgical kits due to insufficient aeration during sterilization, which may compromise sterility and increase infection risk for patients.
Product
American Contract Systems Gyn Laparoscopy convenience kit
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-2537-2024·2024-08-14
Medical Device Hookup Instructions Incorrect, Risking Endoscope Disinfection
Steris Corporation recalls 129 Hookup devices (Model 2-8-540HAN) due to incorrect hookup instructions in product documentation. Using wrong connections may prevent proper endoscope disinfection, creating infection risk.
Product
Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispens
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-2539-2024·2024-08-14
Medical Device Hookup Instructions Contain Errors Affecting Endoscope Disinfection
Steris Corporation recalls certain automated endoscope reprocessor hookups due to incorrect instructions in product documentation. Improper hookup connection could prevent proper endoscope disinfection, risking patient infection.
Product
Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated Endoscope Reprocessors ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexib
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2463-2024·2024-08-14
GE SIGNA HDxt 3.0T MRI systems may overheat implanted devices
GE Medical Systems is recalling 3.0T SIGNA HDxt MRI systems because radiofrequency energy can exceed safety limits under specific operating conditions, potentially overheating implanted medical devices in patients.
Product
3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1HD16.0_V03, HD23.0_V03; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2542-2024·2024-08-14
Olympus Everest Bipolar Cutting Forceps Recalled for Packaging Defects
Olympus is recalling Everest Bipolar Cutting Forceps due to fractures and breakages in packaging trays and Tyvek covers that may compromise sterility. The recall affects 4,364 units distributed worldwide.
Product
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of c
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-2481-2024·2024-08-14
SIGNA UHP MRI System Software Versions May Cause Implant Overheating
GE Medical Systems is recalling SIGNA UHP MRI systems with software versions RX28.0 or MR30.1. A configuration issue can cause radiofrequency output to exceed prescribed limits, potentially overheating MR conditional implants.
Product
SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use only
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2484-2024·2024-08-14
SIGNA MAGNUS MRI Software Can Overheat Implanted Devices
GE Medical Systems recalled SIGNA MAGNUS MRI systems with software versions MR29.1 or RX29.1. Under specific imaging conditions in Low SAR Mode, the system may exceed safe radiofrequency power limits and cause implanted medical devices to overheat.
Product
SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magnetic Resonance Imaging System - research use only
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2538-2024·2024-08-14
Steris Endoscope Reprocessor Hookups: Incorrect Instructions Risk Improper Disinfection
Steris recalls Hookup Model 2-8-540CAS endoscope reprocessor units due to incorrect instructions that could prevent proper disinfection. Using incorrect hookup connections may lead to patient contamination or infection risk.
Product
Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispens
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2522-2024·2024-08-14
American Contract Systems Cataract Pack Kits Recalled Due to Insufficient Sterilization Aeration
American Contract Systems is recalling Cataract Pack convenience kits due to insufficient aeration time during sterilization. The affected units may not be properly sterilized.
Product
American Contract Systems Cataract Pack convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2469-2024·2024-08-14
GE SIGNA Artist MR system may overheat implants in certain sequences
GE Medical Systems is recalling SIGNA Artist MR imaging systems because they may produce radiofrequency power exceeding user-set limits when using certain imaging sequences in Low SAR Mode, potentially causing MR-conditional implants to overheat.
Product
SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2531-2024·2024-08-14
Pulmonary Heart Valve Grafts Recalled Due to Invalid Test Results
Artivion is recalling two CryoValve SG heart valve grafts that were approved and implanted with invalid test results.
Product
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2460-2024·2024-08-14
GE SIGNA Pioneer MR Systems May Overheat Patient Implants During Scanning
GE SIGNA Pioneer MR systems with certain software versions may allow radiofrequency exposure to exceed prescribed limits in Low SAR Mode when using specific imaging sequences, potentially causing overheating of MR conditional implants.
Product
SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX26.1, PX28.0 to PX28.4, PX29.0, PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2473-2024·2024-08-14
MR System Software Defect May Cause Implant Overheating During Scanning
GE SIGNA Explorer MR imaging systems with affected software versions may overheat implants during certain scan sequences. 2,528 units affected worldwide; no injuries reported.
Product
SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2527-2024·2024-08-14
Medical X-ray display system support arm may lower unexpectedly
Siemens LUMINOS Lotus Max X-ray displays are being recalled because the support arm may lower unintentionally, potentially injuring people nearby during positioning.
Product
LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2512-2024·2024-08-14
Baxter Precision Surgical Table Recall: Loose Spring Pins Risk
Baxter Healthcare Corporation is recalling the PST 500 U Precision Surgical Table due to loose spring pins that can cause the tabletop to unexpectedly tilt or move, potentially causing unintended patient movement during surgery.
Product
Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2529-2024·2024-08-14
Paraffin Embedding Station Recalled for Internal Fire and Toxic Smoke Risk
The FDA is recalling 180 Leica HistoCore Arcadia H paraffin embedding stations due to a sealing defect in the paraffin tank that can cause toxic smoke and internal fire.
Product
Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
Category
Medical Device
Distribution
Distributed nationwide

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5601–5625 of 13543