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

8326–8350 of 13683

HighFDA (Devices)·Z-2601-2023·2023-09-27
Stryker ACM System Femoral Nozzle Recall for Potential Disassembly
Stryker is recalling its ACM Advanced Cement Mixing System due to a defect in the Break-Away Femoral Nozzle that can disassemble or break off during surgical use, risking loss of device function and foreign material in the surgical site.
Product
Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-703-000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2593-2023·2023-09-27
APK2 Wheelchair Cushion Battery Pack Defect Can Cause Overheating
Aquila Corporation recalls 117 APK2 wheelchair cushions with defective battery packs that can overheat. The risk could result in property damage and injury.
Product
APK2 Pressure-Sensing Wheelchair Cushions
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2624-2023·2023-09-27
FDA Recalls ALKP Chemistry Analyzer Slides for Potential Diagnostic Errors
Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry ALKP Slides worldwide because high alkaline phosphatase samples may cause the analyzer to report falsely low results, potentially missing or delaying liver disease diagnoses.
Product
VITROS XT Chemistry Products ALKP Slides
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2600-2023·2023-09-27
Stryker ACM Cement Mixing System nozzle may break during surgery
Stryker is recalling ACM Systems due to potential breakage of the femoral nozzle applicator tip during use. This could cause device failure and leave components in the surgical site.
Product
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-573-000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2615-2023·2023-09-27
Abbott Implantable Defibrillator Devices Recalled for Bluetooth Malfunction
Abbott is recalling certain implantable defibrillator devices manufactured before April 2022 due to a Bluetooth malfunction that results in loss of wireless communication and potential excessive battery drain.
Product
Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac Resynchronization Therapy Defibrillator: NxT HF CRT-D REF CDHFA600Q Entrant HF Cardiac Resynchronization Therapy Defibrillator : HF CRT-D REF CDHFA300Q The primary f
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2596-2023·2023-09-27
Stryker ACM Bone Cement Mixer Nozzle May Break During Surgery
Stryker ACM bone cement mixing system nozzles may break or disassemble during surgical use, causing loss of function and risk of material fragments in the surgical site. Users should stop using affected units.
Product
Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a constant high vacuum through the process. Catalog number: 0206-512-000.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2610-2023·2023-09-27
TyTek Tension Pneumothorax Access Kit Recalled for Inadequate Placement Instructions
Tytek Medical Inc is recalling the TyTek Tension Pneumothorax Access Kit (Model TM-303) because the instructions do not adequately identify the risks associated with needle decompression or clearly show proper placement site location.
Product
TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-303
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2622-2023·2023-09-27
COOLIEF RF Generator recalls due to F100 and F101 fault complaints
Avanos Medical is recalling 24 COOLIEF RF Generator units that have produced F100 and F101 faults. Units were distributed to 17 U.S. states and Brazil.
Product
COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system is controlled via a touch screen interface display that includes user controls, alarm messages, and
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-2609-2023·2023-09-27
Chemistry Quality Control Material Recalled for Transcription Error in Instructions
Randox Laboratories recalled Liquid Assayed Chemistry Control Premium Plus Level 3 due to incorrect standard deviation values in the product instructions. The error could affect patient result reporting, but the correct operating values remain available.
Product
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2619-2023·2023-09-27
MINISCAV Vacuum Pump Recalled for Inadequate Acceptance Documentation
R A Medical Services has recalled 10 MINISCAV Vacuum Pump units distributed in Ohio due to inadequate documentation of the product acceptance activity during manufacturing.
Product
MINISCAV (tm) Vacuum Pump
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2590-2023·2023-09-27
Arrow ErgoPack PICC Catheters Recalled for Incorrect Product Labeling
Arrow International is recalling 190 units of Arrow ErgoPack One-Lumen PICC catheters (Lot 13F22J0617) because the product code and product name were incorrectly printed on the kit packaging. The units were distributed nationwide.
Product
Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2592-2023·2023-09-27
Sentec Membrane Changer components recalled for manufacturing defect
SenTec AG recalls Membrane Changer components for the Sentec Digital Monitoring System due to a potential manufacturing defect that could affect measurement accuracy.
Product
Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDM
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2613-2023·2023-09-27
Prucka 3 Amplifier Power Supply May Fail and Cause Device Inoperability
GE Medical Systems is recalling Prucka 3 Amplifiers and related field replaceable units used in CardioLab and ComboLab systems. A power supply diode may overheat and fail, causing the amplifier to stop working.
Product
Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-2627-2023·2023-09-27
Epidural Anesthesia Sets Recalled Due to Incorrect Lid Stock Label
B. Braun Medical is recalling approximately 3,440 Perifix® epidural anesthesia sets due to incorrect labeling of the lid stock. The mislabeled products were distributed to multiple U.S. states.
Product
Perifix¿ / Epidural anesthesia set, medicated
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-2611-2023·2023-09-27
TyTek Tension Pneumothorax Access Kit Instructions Updated for Needle Decompression Safety
Tytek Medical is updating instructions and visual guidance for its tension pneumothorax kit to clarify needle decompression risks and proper placement. The update affects 4,400 units distributed in the US and international locations.
Product
TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-310
Category
Medical Device
Distribution
3 states
LowFDA (Devices)·Z-2591-2023·2023-09-27
Arrow ErgoPack PICC catheter kits recalled for incorrect product labeling
Arrow International recalled 177 ErgoPack PICC catheter kits because the product code and name were incorrectly listed on the packaging. No illnesses or injuries reported.
Product
Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2509-2023·2023-09-20
Abbott Proclaim DRG Implantable Pulse Generators cannot exit MRI mode
Abbott Medical is recalling approximately 17,394 Proclaim DRG Implantable Pulse Generators worldwide due to reports that patients cannot exit MRI mode on affected devices. This malfunction may prevent normal device operation when mode-switching is needed.
Product
Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery with
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2450-2023·2023-09-20
Mallinckrodt One-Way Valve Recalled Due to Potential Oxygen Flow Failure
Mallinckrodt Manufacturing is recalling approximately 13,600 One-Way Valves used with ventilators due to risk of valve sticking and oxygen flow reduction. The Class I recall affects worldwide distribution.
Product
Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2508-2023·2023-09-20
Proclaim Plus 7 Implantable Pulse Generator Cannot Exit MRI Mode
Abbott Medical recalled Proclaim Plus 7 Implantable Pulse Generators due to a defect preventing patients from exiting MRI mode. This operational failure could compromise device functionality during or after magnetic resonance imaging procedures.
Product
Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery w
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2506-2023·2023-09-20
Proclaim XR 7 Implantable Pulse Generators unable to exit MRI mode
Abbott Medical is recalling Proclaim XR 7 Implantable Pulse Generators due to a malfunction that prevents patients from exiting MRI (Magnetic Resonance Imaging) mode, potentially disrupting normal device operation and therapy delivery.
Product
Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It i
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2511-2023·2023-09-20
Infinity 7 Implantable Pulse Generator Recall Due to MRI Mode Exit Failure
Abbott Medical recalls Infinity 7 Implantable Pulse Generators due to reports that patients cannot exit MRI mode. The FDA has classified this as a Class I recall affecting devices distributed worldwide.
Product
Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2514-2023·2023-09-20
FDA Recalls Medline Hudson RCI Addipak Inhalation Solution for Sterility Failure
Medline Industries is recalling HUDSON RCI Addipak 5mL sterile saline inhalation solution due to sterility failure. Approximately 18,000 units were distributed nationwide; the product was intended for scrap but was inadvertently shipped to customers.
Product
HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2510-2023·2023-09-20
Abbott Infinity 5 Implantable Pulse Generator Patients Unable to Exit MRI Mode
Some Abbott Infinity 5 implantable pulse generator patients report being unable to exit MRI mode on their devices. This Class I recall affects 5,932 devices distributed globally.
Product
Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2507-2023·2023-09-20
Abbott Proclaim Plus 5 Implantable Pulse Generator MRI Mode Exit Failure
Abbott Medical is recalling Proclaim Plus 5 Implantable Pulse Generators (Model 3670) due to reports that patients are unable to exit MRI mode on the devices.
Product
Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery w
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2505-2023·2023-09-20
Proclaim XR 5 Implantable Pulse Generators Cannot Exit MRI Mode
Abbott Medical recalled the Proclaim XR 5 Implantable Pulse Generator after patients reported being unable to exit MRI mode on their devices. Approximately 113,784 units were distributed worldwide.
Product
Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes
Category
Medical Device
Distribution
Distributed nationwide

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8326–8350 of 13683