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

9551–9575 of 13717

HighFDA (Devices)·Z-1471-2023·2023-05-03
Draeger Infinity CentralStation ECG waveform display inaccuracy due to software defect
Draeger Infinity CentralStation patient monitors may display ECG waveform amplitudes lower than actual values due to a software bug affecting versions VG2.1.3 and lower.
Product
Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1472-2023·2023-05-03
Draeger Infinity M300 Patient Monitor Software Displays Inaccurate ECG Readings
Draeger Infinity M300/M300+ patient monitoring systems may display or print ECG waveforms with inaccurate QRS amplitudes due to software peaks being dropped on narrow waveforms.
Product
Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1435-2023·2023-05-03
Sterile Surgical Kit Light Handle Covers May Separate During Use
ROi CPS LLC is recalling 386 sterile surgical convenience kits (WPH GYN Laparoscopy Pack) because light handle covers may separate and fall off during use.
Product
Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1429-2023·2023-05-03
Hamilton HAMILTON-C6 Ventilator Software Error Disables Patient Input Monitoring
The HAMILTON-C6 ventilator (103 units) has a software error that disables patient input monitoring when switching to adaptive ventilation modes with a connected controller or humidifier. The device will alarm but cannot respond to patient inputs.
Product
HAMILTON-C6, REF: 160021
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1421-2023·2023-05-03
Carefusion Vaginal Specula Recalled for Incorrect Labeling and Packaging
Carefusion recalled 726 units of two vaginal specula models with labels and laser etchings switched during packaging. This mislabeling could result in use of an unintended product.
Product
(1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm); and (2) Carefusion V. Mueller Pederson Vaginal Specula, Catalog #GL31, Medium, 4 x 7/8" (10.2 x 2.2cm).
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1465-2023·2023-05-03
VersaOne Reusable Positioning Cannula Recalled Due to Internal Metal Burrs
Covidien LP is recalling VersaOne Reusable Positioning Cannulas (Model RC12STS) due to manufacturing defects that may produce metal burrs on the inside of the device, potentially causing internal tissue damage during use.
Product
VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1438-2023·2023-05-03
Surgical Kit Light Handle Covers May Separate During Use
ROi CPS LLC is recalling 1,369 sterile surgical convenience kits because light handle covers may separate and fall off during use. The affected kits were distributed nationwide in Florida and Missouri.
Product
Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, OR01034C - Total Knee; 4. regard Item Number: 880474001, OR01106A - Knee Arthro
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1431-2023·2023-05-03
Surgical Convenience Kits Recalled for Separating Light Handle Covers
ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. The recall affects 278 kits distributed in Florida and Missouri.
Product
Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1463-2023·2023-05-03
VersaOne Reusable Positioning Cannula Recalled for Internal Metal Burr
Covidien LP is recalling 145 units of the VersaOne Reusable Positioning Cannula due to a manufacturing defect that may create a metal burr inside the device at the weld joint.
Product
VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1461-2023·2023-05-03
GEM NEUROTUBE Nerve Repair Mesh Recalled for Brittleness and Potential Crumbling
Baxter Healthcare's GEM NEUROTUBE absorbable mesh tube, used for peripheral nerve repair, is recalled because the product is brittle and may crumble when handled or removed from packaging. The recall affects 169 units distributed worldwide.
Product
GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1430-2023·2023-05-03
Caspar Cervical Retractor Basket Lids Recalled for Incorrect GTIN Labeling
Aesculap Implant Systems recalls Caspar Cervical Retractor (CCR) Basket lids with incorrect GTIN labeling. The product bears GTIN #04046955299592 instead of the correct #04046955299607.
Product
Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments. Note: The CCR basket
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1462-2023·2023-05-03
Cardiosave Hybrid Intra-Aortic Balloon Pump Power Cord Incompatible with Brazilian Outlet
Datascope Corp. is recalling 54 units of the Cardiosave Hybrid Intra-Aortic Balloon Pump distributed to Brazil. The Type J power cord plug is incompatible with Brazilian Type N electrical receptacles.
Product
MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1357-2023·2023-04-26
Shiley Adult Flexible Tracheostomy Tubes Recalled Due to Undersized Connectors
Covidien is recalling Shiley Adult Flexible Tracheostomy Tubes due to undersized connectors that create loose connections with 15mm respiratory circuit components. Unsecure connections could cause respiratory failure, difficulty breathing, treatment delays, or serious injury.
Product
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description): 10CN10H, 10.0MM SHILEY CUFFED TRACH CAN; 10CN10R, 10.0MM ADT FLEX TRACH W TG CUFF; 10UN10A, 10.0MM UNCUFF TRACH TUBE X1;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1409-2023·2023-04-26
Spinal implant screws recalled due to defective titanium material
Medtronic is recalling 45 units of INFINITY Multi-Axial Screws (lot H5802983) worldwide because incorrect titanium was used, reducing the screw head's gripping strength. No illnesses or injuries have been reported.
Product
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1392-2023·2023-04-26
BioFire FilmArray GI Panel Recalled for Potential False Negative Results
BioFire Diagnostics is recalling FilmArray Gastrointestinal Panel test kits due to a manufacturing issue that may produce false negative results. Affected units may fail to detect gastrointestinal infections.
Product
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1405-2023·2023-04-26
Spinal fusion device antibackout screw may break, FDA recalls
Medacta Usa Inc is recalling MectaLIF ANTERIOR antibackout lag covers due to potential breakage of the small screw that affixes the anti-backout plate. The defect affects spinal fusion procedures in select US states.
Product
MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1417-2023·2023-04-26
Philips 2D Perfusion Medical Imaging Software Recalled for Signal Processing Errors
Philips is recalling 2D Perfusion diagnostic imaging software due to signal processing errors that can produce inaccurate presentations, potentially affecting clinical decisions.
Product
2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1394-2023·2023-04-26
Radiometer AQURE Software Recall Due to Patient Mix-up Risk
Radiometer is recalling AQURE laboratory software versions 2.5.2 through 2.6.1 due to a potential issue that could cause patient data mix-ups.
Product
AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from co
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1411-2023·2023-04-26
Spinal Implant Screws Recalled for Defective Titanium Material
Medtronic is recalling INFINITY spinal implant screws manufactured with incorrect titanium material. The defect reduces the screw's gripping strength, risking implant performance in critical spinal fusion surgery.
Product
INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, REF 360PT4022; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unctio
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1414-2023·2023-04-26
Samsung GM85 Digital X-ray Imaging System Arm Latch Failure
NeuroLogica Corporation recalls 935 Samsung GM85 digital X-ray systems due to a faulty arm latch in the column support that could allow the arm to fall, creating a risk of bodily injury.
Product
Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1395-2023·2023-04-26
Instrument Kit Drill Guides Have Incorrect Depth Range
GEO Instrument Kits for EPS Plates contain drill guides marked with an incorrect depth range (30mm-60mm instead of 10mm-40mm), which could affect surgical implant placement.
Product
GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1420-2023·2023-04-26
Baxter ExactaMed Oral Dispenser Recalled for Particulate Matter Contamination
Baxter Healthcare Corporation is recalling the ExactaMed 20 mL Oral Dispenser (Lot B301S356P) because it may contain particulate matter. The recall affects approximately 91,100 units distributed in the US.
Product
ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1401-2023·2023-04-26
Medacta interbody fusion plate device recalled for screw breakage
Medacta Usa Inc is recalling the MectaLIF ANTERIOR interbody fusion device because the small screw affixing the anti-backout plate may break, potentially compromising device integrity.
Product
MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1399-2023·2023-04-26
Tobii Dynavox TD I-110 Speech Device Recalled Over Loose Battery Risk
The FDA is recalling the Tobii Dynavox TD I-110, a speech-generating device, because the battery may become loose from its housing and potentially be damaged. This affects users worldwide who depend on this device for communication.
Product
Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1415-2023·2023-04-26
Laboratory diagnostic device software issue may delay clinical diagnosis
BD Kiestra InoqulA+ (software versions 5.1/5.1.1) fails to display plate information after processing in clinical laboratories, risking diagnostic delays or specimen recollection.
Product
BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform. An in vitro diagnostic medical device intended to automate specimen processing according to user-defined procedures and protocols. Catalog (Ref) No. : 447213
Category
Medical Device
Distribution
Distributed nationwide

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9551–9575 of 13717