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

8851–8875 of 13717

HighFDA (Devices)·Z-2207-2023·2023-07-26
Medtronic Durepair Dura Matrix Recalled Due to Endotoxin Contamination
Medtronic is recalling Durepair Dura Regeneration Matrix surgical implants worldwide due to potential endotoxin contamination that may cause inflammation similar to infection.
Product
Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 6
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2205-2023·2023-07-26
Medline Ultrasound Probe Cover Kits recalled for inadequate seam barrier
Medline Industries is recalling 4,500 Probe Cover Kits because the covers have inadequate barriers at the seams, which may compromise sterility.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS985566Q; c) MAJOR ORTHO-LF, Model Number DYNJ0949139I; d) BSHR TOTAL KNEE-LF, Model Number DYNJ24525K; e) BSHR TO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2155-2023·2023-07-26
Medline Ultrasound Probe Cover Kits recalled for inadequate seam barrier
Medline is recalling Probe Cover Kits that may have inadequate barrier at the seams, potentially compromising sterility during diagnostic ultrasound procedures. The recall affects kits distributed worldwide from December 2017 through May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ANESTHESIA OH TOTE, Model Number DYNJ61476
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2201-2023·2023-07-26
Medline probe covers with inadequate seam barrier may allow contamination
Medline is recalling Probe Cover Kits due to inadequate barriers at the seams, which may allow contamination during ultrasound procedures. The recall affects 51,200 units distributed worldwide between December 2017 and May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PROBE COVER PACK, Model Number DYNDA1219
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2145-2023·2023-07-26
Beckman Coulter DxA Automation System software defect may cause incorrect test results
Beckman Coulter DxA Automation Systems contain a software defect that may cause tests to run on incompatible sample tube types, potentially producing erroneous patient results.
Product
Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-2192-2023·2023-07-26
Medline Ultrasound Probe Cover Kits Recalled for Inadequate Sterile Barrier
Medline Probe Cover Kits used during ultrasound procedures may have an inadequate barrier at the seams that could compromise sterility. The manufacturer is recalling 180 units distributed worldwide between December 2017 and May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ARTHROSCOPY PACK, Model Number DYNJ44322G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2157-2023·2023-07-26
Medline Ultrasound Probe Cover Kits Recalled Due to Barrier Defect
Medline is recalling Pediatric EP Pack ultrasound probe cover kits with sterile gel because the probe covers may have inadequate barriers at the seams, potentially compromising sterility during diagnostic procedures.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK, Model Number DYNJ45158A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2214-2023·2023-07-26
Ultrasound reporting software recalled by manufacturer for software issue
Digisonics has voluntarily recalled OBView ultrasound reporting software versions 4.8.2 SP6 through 4.8.3 due to a software issue. The recall affects 32 units distributed across multiple U.S. states and Aruba.
Product
Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-2146-2023·2023-07-26
Aesculap Surgical Needle Recalled for Incorrect Product Code Marking
Aesculap Implant Systems is recalling Aesculap Surgical Needles (MD610) because they are etched with an incorrect product code. The needles are marked MD611 when they should be marked MD610.
Product
Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2103-2023·2023-07-19
Baxter SIGMA Spectrum Infusion Pump false upstream occlusion alarm correction
Baxter is correcting false upstream occlusion alarms in SIGMA Spectrum and Spectrum IQ infusion pumps following software upgrades affecting approximately 3,306 units distributed nationwide in the US.
Product
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2018-2023·2023-07-19
Oxylog 3000 Plus ventilator may stop working during operation
The Draeger Oxylog 3000 Plus emergency and transport ventilator may stop working when transitioning from battery to AC operation. Approximately 300 units distributed nationwide and internationally are affected.
Product
Oxylog 3000 Plus emergency and transport ventilator
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2110-2023·2023-07-19
Abbott Cardiac Catheter Sheath Recalled Due to Air Embolism Risk
Abbott is recalling the Amplatzer Steerable Delivery Sheath (ASDS), a cardiac catheter, due to a 0.77% reported incidence rate of air embolism during procedures. The recalled 675 units are distributed worldwide.
Product
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2104-2023·2023-07-19
Spectrum IQ Infusion System False Occlusion Alarm Correction Issued
The FDA has issued a Class I correction for Baxter's Spectrum IQ Infusion System due to increased false upstream occlusion alarms following software updates. Approximately 19,861 units are affected nationwide.
Product
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2119-2023·2023-07-19
Medtronic Catalyft LS Spinal Implants Recalled for Out-of-Specification Dimensions
Medtronic recalls 25 units of Catalyft LS spinal implants (lot numbers NM21J039, NM21M026) due to out-of-specification device dimensions that may affect surgical fit and function.
Product
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2121-2023·2023-07-19
Medtronic Catalyft LS Spinal Implant Recall Due to Out-of-Specification Geometry
Medtronic recalls 10 units of Catalyft LS spinal implants due to potential out-of-specification device geometries. The affected implants may not properly support or accommodate patient anatomy during lumbar fusion surgery.
Product
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2138-2023·2023-07-19
Medical Blood Cell Diluent Recalled for Out-of-Specification Parameters
Beckman Coulter is recalling specific lots of COULTER DxH Diluent due to out-of-specification conductivity, osmolality, and pH. The diluent may produce inaccurate blood cell test results.
Product
COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2128-2023·2023-07-19
Abiomed Introducer Set Recall Due to Sidearm Detachment Risk
Abiomed 14Fr Low Profile Introducer Sets are being recalled due to silicone oil contamination that may cause sidearm detachment during use. One detachment has been documented; no injuries have been reported.
Product
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2135-2023·2023-07-19
Medline Non-Sterile PVP Solution Incorrectly Labeled as Sterile
Medline is recalling Non-Sterile PVP Solution Hystero Pack kits due to mislabeling: affected lots labeled as 'Sterile' when actually 'Non-Sterile'. Using non-sterile solution in sterile gynecological procedures creates infection risk.
Product
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2125-2023·2023-07-19
GE Healthcare Vivid S70 ultrasound systems fail to boot timely
GE Healthcare Vivid S70 ultrasound devices may experience delayed startup. This can reduce equipment availability during time-critical emergency situations.
Product
GE Healthcare Vivid S70, ultrasound device
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2126-2023·2023-07-19
GE Healthcare Vivid S60N ultrasound devices experience boot-up delays
GE Healthcare Vivid S60N ultrasound systems may fail to boot in a timely manner. This can delay device availability during time-critical emergency situations.
Product
GE Healthcare Vivid S60N, ultrasound device
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2109-2023·2023-07-19
Surgical chest support device recalled for potential cracking at attachment
Baxter Healthcare recalls 1,010 Allen Advance Chest Support devices due to potential cracking where the support attaches to operating room table rails. No injuries reported.
Product
Allen Advance Chest Support with Pad
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2130-2023·2023-07-19
Ambulance stretcher base leg assembly may bend causing tip and unstable motion
Stryker Power-PRO 2 ambulance cots may develop bent base leg assemblies, risking cot tips, unstable motion, and operational difficulties. Approximately 1,980 units were recalled.
Product
Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is designed to support and transport a maximum weight of 700 lb (318 kg). Model Number: 6507
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2120-2023·2023-07-19
Medtronic Catalyft LS Spinal Implants Recalled for Out-of-Specification Geometry
Medtronic is recalling 11 units of its Catalyft LS Expandable Interbody System spinal implants due to potential out-of-specification dimensions that could affect surgical fit and stability.
Product
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2129-2023·2023-07-19
Ortho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Calibrator Kit 20 due to measurement bias affecting laboratory results for immunoglobulin and complement protein testing. Falsely elevated or reduced values could be reported.
Product
VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2131-2023·2023-07-19
Medline PVP solution mislabeled as sterile when non-sterile
Medline Industries is recalling batches of non-sterile PVP solution that were incorrectly labeled as sterile, creating risk of inadvertent use in sterile medical settings.
Product
MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A
Category
Medical Device
Distribution
Distributed nationwide

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8851–8875 of 13717