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

3551–3575 of 27375

HighFDA (Devices)·Z-0751-2025·2025-01-01
Daytona Small Stature Locking Caps recalled for manufacturing defects
SeaSpine Orthopedics is recalling 92 Daytona Small Stature CoCr Locking Caps due to manufacturing defects that prevent proper component mating. The devices were distributed in seven U.S. states.
Product
Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0747-2025·2025-01-01
Medical Device Recall: BD FACSLyric Flow Cytometer Power Supply Failure Risk
BD is recalling power supply modules in FACSLyric flow cytometers that may fail to power on or remain powered. Failure could expose lab staff to fumes and cause patient specimen loss or delayed test results.
Product
FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath tan
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0742-2025·2025-01-01
Galaxy System bronchoscope power supply defect may injure lung tissue
Noah Medical's Galaxy System bronchoscope has defective power supply semiconductors that may fail during procedures, potentially causing pneumothorax or lung tissue injury when the scope is manually removed.
Product
Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-0748-2025·2025-01-01
BD FACSLyric Flow Cytometer Power Supply Module Failure Risk
BD is recalling power supply modules on FACSLyric flow cytometers that may fail to power on or stay on. Failure could cause lab staff to inhale fumes and patients to need repeat blood draws.
Product
FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath ta
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0767-2025·2025-01-01
Siemens magnesium reagent cartridges recalled for false measurement results
Siemens is recalling two lots of Magnesium Flex reagent cartridges due to potential falsely low magnesium measurements. The intermittent error may not be detected by standard quality control procedures.
Product
Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0717-2025·2025-01-01
Surgical Patties and Strips Recalled for Endotoxin Contamination
Medline Industries recalls specific lots of surgical patties and strips in MAJOR NEURO PACK-LF Convenience kits due to higher-than-expected endotoxin levels detected in raw materials, which may have resulted in out-of-specification finished products.
Product
MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0667-2025·2024-12-25
Draeger Atlan A300 anesthesia workstation ventilator failure FDA Class I recall
Draeger Atlan A300 anesthesia workstations can fail to ventilate properly before or during use. The FDA classified this as Class I due to the critical risk to patient ventilation.
Product
Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0661-2025·2024-12-25
Medtronic Becker Neurosurgical Drainage Systems Recalled for Cracked and Leaking Stopcocks
Medtronic Neurosurgery recalls Becker External Drainage and Monitoring Systems due to reports of cracks and leaks in stopcocks. The recalled systems are used to drain cerebrospinal fluid and monitor pressure in neurosurgery patients.
Product
Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040 BECKER EDMS II 27609 BECKER 27609 W/NEEDLESLESS INJ. SITE 27670 BECKER 27670 STOP BELOW DC NDL-LS IN 27672 BECKER 27672 ONEWAY VLV Y-SI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0658-2025·2024-12-25
Walcott Bipolar Pencil Surgical Instrument Recalled for Potential Tube Detachment
Kirwan Surgical Products is recalling Walcott Bipolar Pencil 25 Gauge surgical instruments due to potential breakage or detachment of the stainless-steel tube. The affected pencils are used in eye and soft tissue surgery.
Product
Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the re
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0655-2025·2024-12-25
Kirwan Surgical Bipolar Pencil Recalled Due to Potential Tube Breakage
Kirwan Surgical Products is recalling its Disposable 25-gauge Bipolar Pencil (Model 14-5011L) because the outer stainless-steel tube may break or detach during use. The defect could create a safety hazard during eye surgery and other soft tissue procedures.
Product
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauteri
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0668-2025·2024-12-25
FDA Recalls Draeger Atlan A300XL Anesthesia Workstation for Ventilator Failure
Draeger Medical recalls the Atlan A300XL anesthesia workstation for potential piston ventilator failure that could occur before use or during anesthesia delivery. Twenty-five units were distributed outside the United States.
Product
Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0659-2025·2024-12-25
Nidek Disposable Bipolar Pencil Surgical Instruments Recalled for Tube Breakage Risk
Kirwan Surgical Products recalls Nidek Disposable Bipolar Pencil surgical instruments due to risk that the stainless-steel tube may break or detach during procedures.
Product
Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauteriza
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0662-2025·2024-12-25
Exacta External Drainage System Stopcocks May Leak or Crack
Medtronic Neurosurgery is recalling Exacta External Drainage and Monitoring Systems worldwide due to complaints of cracking and leaking stopcocks. These components control cerebrospinal fluid drainage and intracranial pressure monitoring.
Product
Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN 27732 EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP 27785 EDMS 27785 EXACTA 50ML BC NDLESS INJ 27795 EDMS
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0660-2025·2024-12-25
Optikon Bipolar Pencil surgical tool recalled for tube failure risk
FDA recalls Kirwan Surgical's Optikon Bipolar Pencil surgical instruments due to risk that the outer stainless-steel tube may break or detach during use. The recalled devices were distributed worldwide.
Product
Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the r
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0654-2025·2024-12-25
Kirwan Surgical Disposable Bipolar Pencils recalled for potential tube failure
Kirwan Surgical Products is recalling 80,060 Disposable Bipolar Pencils (Model 14-5011) because the outer stainless-steel tube may break or detach during surgical use. The devices were distributed worldwide.
Product
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0656-2025·2024-12-25
Surgical Bipolar Pencil Recall: Risk of Tube Breakage During Eye Surgery
Kirwan Surgical Products is recalling disposable bipolar surgical pencils used in eye surgery because the outer stainless-steel tube may break or detach during use.
Product
Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0705-2025·2024-12-25
OEC 9900 Mobile Fluoroscopic X-Ray System Recall for Sealing Defect
GE OEC Medical Systems is recalling 78 OEC 9900 Elite mobile fluoroscopy systems due to insufficient sealing of X-ray tubes. The defect can result in oil leaks and loss of fluoroscopic imaging capability.
Product
OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedures. Examples of clinical application ma
Category
Medical Device
Distribution
45 states
HighFDA (Devices)·Z-0657-2025·2024-12-25
Ambler Surgical Bipolar Pencil recalled for outer tube structural failure
Kirwan Surgical Products is recalling the Ambler Surgical Bipolar Pencil 25 Gauge Straight (Model PD7226) because the outer stainless-steel tube may break or detach during use. 4,470 units worldwide are affected.
Product
Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area durin
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0697-2025·2024-12-25
Tracheal Tube Holder Recalled for Defect Causing Potential Skin Pressure Injury
Medline Industries is recalling 1,464 units of the HUDSON RCI mBrace tracheal tube holder due to adhesive and frame defects that may cause skin pressure injury. The device defect puts pressure on patients' cheekbones and upper lip depending on positioning.
Product
HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0686-2025·2024-12-25
Philips Access Point Software Issue Risks Patient Data Loss
Philips Smart-Hopping 2.0 Access Points may reset after 82 days, risking loss of patient data and network disconnections. No injuries have been reported.
Product
Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0692-2025·2024-12-25
K-Systems Incubator Device Recall: Temperature May Exceed Desired Setting
CooperSurgical is recalling 34 K-Systems incubator devices used in assisted reproduction procedures. The warming surfaces may exceed the desired set temperature, though the device will alarm if this occurs.
Product
Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g.,
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0690-2025·2024-12-25
K-Systems T47 Warming Plate May Exceed Set Temperatures
CooperSurgical recalls K-Systems T47 Warming Plates because temperature may exceed the desired set value, potentially affecting biological materials. The device alarms appropriately when this occurs.
Product
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0707-2025·2024-12-25
Duravent Silicone Ventilation Tubes recalled for product substitution error
Olympus is recalling 984 Duravent Silicone Ventilation Tubes (Model 240075) due to the potential that some units may contain incorrect product—specifically 1.32 mm Tiny T Tubes (Model 70240076) instead of the intended product.
Product
Duravent Silicone Ventilation Tube. Model Number: 240075.
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-0703-2025·2024-12-25
OEC 3D Mobile Fluoroscopic X-Ray System Tube Sealing Defect Recall
GE OEC Medical Systems is recalling 84 OEC 3D mobile fluoroscopic X-ray systems due to manufacturing defects in X-ray tube sealing that can cause oil leaks and loss of imaging capability.
Product
OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions durin
Category
Medical Device
Distribution
45 states
HighFDA (Devices)·Z-0710-2025·2024-12-25
Medical imaging software recall for incorrect DICOM orientation labels
Mint Lesion software versions 3.10.0 and 3.10.1 may display incorrect orientation labels for certain DICOM medical images. The defect affects 18 units distributed across the US and internationally.
Product
mint Lesion, Software Versions: 3.10.0 and 3.10.1.
Category
Medical Device
Distribution
Distributed nationwide

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