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

4176–4200 of 39968

ModerateFDA (Devices)·Z-1575-2025·2025-04-23
ID NOW Influenza A/B 2 24T Nucleic Acid Assay Kits Recalled
Abbott Diagnostics is recalling ID NOW Influenza A/B 2 24T test kits (Model 427-000) nationwide because affected lots have a higher occurrence of invalid test results than stated in the product instructions.
Product
Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1603-2025·2025-04-23
Medline Convenience Kits Recalled for Potentially Weak Breather Pouch Seals
Medline Industries is recalling select sterile convenience kits with Model Number MNS12590 due to potential open or weak seals on breather pouches used in packaging. The affected lot is 24IBH166.
Product
Medline Convenience kits used for various procedures: 1) PRECIP TRAY, Model Number: MNS12590
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1609-2025·2025-04-23
Medline Hernia Repair Convenience Kit Recalls Due to Weak Seals
Medline is recalling Hernia Repair Tote convenience kits (Model DYNJ908337C) because purchased breather pouches used for packaging may have open or weak seals, which could compromise product sterility.
Product
Medline Convenience kits used for various procedures: 1) HERNIA REPAIR TOTE, Model Number: DYNJ908337C
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1613-2025·2025-04-23
Medline Convenience Kits Recalled for Potentially Open Breather Pouches
Medline Industries is recalling 706 units of various sterile convenience kits used for gynecological and other procedures due to potential open or weak seals on breather pouches. The packaging defect could affect product sterility.
Product
Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number: DYNJ69733; 2) NHS - LAP BOWEL GNG, Model Number: DYNJ39904A; 3) LAPAROSCOPY GYN SURGERY PA, Model Number: DYNJ64651A; 4) GYNE - LITHOTOMY MAJOR-LF, Model Number: DYNJ49250F; 5) ENS. GYNE
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1601-2025·2025-04-23
Medline Convenience Kits Recalled for Potential Weak Breather Pouch Seals
Medline Industries is recalling select sterile convenience kits due to potential open or weak seals on breather pouches used for packaging. The issue affects 116 units distributed worldwide.
Product
Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, Model Number: DYNJ907733B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1587-2025·2025-04-23
Medline Convenience Kits Rhinoplasty Pack Potential Weak Seals Recall
Medline Industries is recalling Rhinoplasty Pack convenience kits (Model DYNJ84116A, Lot 24IBH580) due to potential open or weak seals on breather pouches used for packaging. Compromised packaging may affect sterility of the sterile kits.
Product
Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1605-2025·2025-04-23
Medline Convenience Kit NAIL PACK Sterile Packaging Seal Defect Recall
Medline is recalling select NAIL PACK sterile convenience kits (Model SUT15830A, Lot 24IBR642) due to potential open or weak seals on breather pouches used for product packaging.
Product
Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1512-2025·2025-04-16
Hippo 072 Aspiration System recalled for distal tip detachment risk
Qapel Medical Inc. is recalling the Hippo 072 Aspiration System and related components because the aspiration catheter distal tip may detach, potentially causing vessel rupture or vasospasm.
Product
Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah Delivery Tool, REF: AP6072-132. 072 Aspiration Tubing, REF: APT-95
Category
Medical Device
Distribution
29 states
SevereFDA (Devices)·Z-1456-2025·2025-04-16
Medline medical procedure kits with Medtronic Aortic Root Cannula recalled
Medline Industries is recalling medical procedure kits containing a Medtronic Aortic Root Cannula due to a Class I defect. The kits were distributed to healthcare facilities in nine states.
Product
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN HEART
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-1543-2025·2025-04-16
Stimulation RC Clinician Programmer Application Software Communication Issue
The Stimulation RC Clinician Programmer Application (Model A71400) has a software issue that can permanently disable communication with certain implantable neurostimulators when a specific intraoperative programming sequence is used. Approximately 1,493 devices were distributed worldwide.
Product
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1459-2025·2025-04-16
Medline Medical Procedure Kits with Medtronic Aortic Cannula Recalled
Medline medical procedure kits containing a Medtronic Aortic Root Cannula are being recalled due to potential excess material in the male lures on the aortic cannula. The kits were distributed in nine US states.
Product
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL DR. C PACK, TOL DR. M PACK.
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-1458-2025·2025-04-16
Medline Heart Basin Procedure Kits with Aortic Cannula Recalled
Medline medical procedure kits containing Medtronic Aortic Root Cannula are recalled due to potential excess material in the male luer connectors on the aortic cannula.
Product
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-1457-2025·2025-04-16
Medline Medical Procedure Kits with Aortic Root Cannula Recalled
Medline is recalling medical procedure kits containing a Medtronic Aortic Root Cannula due to potential excess material in the male lures on the cannula. The recall affects 468 units distributed across nine US states.
Product
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-1505-2025·2025-04-16
Medline Medical Convenience Kits Recalled for Defective Endotracheal Tubes
Medline is recalling multiple medical convenience kits distributed in California that contain defective intubation endotracheal tubes previously recalled by the manufacturer Smiths Medical. The affected kits are used for neonatal and pediatric resuscitation and intubation procedures.
Product
Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION KIT, REF ACC010381A; 3) NEWBORN RESUSCITATION KIT, REF ACC010381B; 4) NEWBORN RESUSCITATION KIT, REF ACC010381C; 5) PEDS GREY-PINK-RED, REF ACC010395; 6
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1529-2025·2025-04-16
Beckman Coulter DxI 9000 Immunoassay Analyzer Electrical Short Risk
Beckman Coulter is recalling certain DxI 9000 Access Immunoassay Analyzer units due to ground screws on PCB boards that may cause electrical shorts, leading to smoke and delayed patient test results.
Product
DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1544-2025·2025-04-16
DNA Labeling Kit Component Affected by Chromosome Aberration
Agilent's GenetiSure Dx Labeling Kit contains a human reference DNA component with a mosaic aberration that may cause false test results and diagnosis delays in genetic testing.
Product
GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A).
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1518-2025·2025-04-16
FilmArra Pneumonia Panel Plus Diagnostic Kit Recalled for Control and Test Failures
BioFire Diagnostics is recalling 29 units of the FilmArra Pneumonia Panel Plus test kit due to control failures and false negative results. Affected units (Lot 0979424) were distributed to France, Italy, Spain, Switzerland, and Israel.
Product
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1532-2025·2025-04-16
Omnicell IVX Station Reconstitution Transfer Sets Recall
Omnicell is recalling IVX Station Reconstitution Transfer Sets (Model 298921215) that were shipped in an unvalidated packaging configuration and cannot be assured to be sterile. The devices were intended only for engineering use during setup and system calibration, not clinical use.
Product
IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transfer Set is used for the reconstitution of drug vials in hospital pharmacies. I
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1530-2025·2025-04-16
Wayson Hydrocolloid Bandages Recalled Due to Sterility Compromise Risk
Medline Industries is recalling multiple Wayson Hydrocolloid bandage models due to potential compromise of device sterility. The recalled products were distributed nationwide in the US and internationally.
Product
Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93", 2) Model Number: MJ18004, DBD-MEIJER,BANDAGE,HYDROCOLLOID,HEEL,OVL 3) Model Number: MJ18005, MEIJER,BANDAGE,HYDROCOLLOID,ALLPURP,10CT 4) Model Number: MJ76126V1, DBD-MEIJER,HYDROCOL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1545-2025·2025-04-16
BD Pyxis automated dispensing cabinets recalled for software dosing bug
CareFusion 303 is recalling BD Pyxis MedBank and MedFlex automated dispensing cabinets due to a software bug that prevents accurate tracking of medication quantities, potentially causing patients to receive more than the intended dose.
Product
BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (ADC) intended to securely store and dispense medications to a qualified and authorized user in a clinical settings.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1548-2025·2025-04-16
Medline ReNewal ENT Coblator II PROcise XP Wand recalled
Medline has recalled 315 units of the ReNewal ENT Coblator II PROcise XP Wand nationwide because the drip chamber may disconnect from the saline line tubing under tension.
Product
MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1549-2025·2025-04-16
Medline ReNewal ENT Coblator II Suction Device Drip Chamber Disconnection
Medline ReNewal is recalling 224 units of ENT Coblator II PROcise mAx devices because the drip chambers may disconnect from the saline line tubing under tension, creating a potential surgical hazard.
Product
MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1550-2025·2025-04-16
BD Pyxis MedBank CUBIE Replenishment Station software issue
A software issue in the BD Pyxis MedBank CUBIE Replenishment Station prevents medication restocking when users receive an error message, potentially delaying patient access to medications.
Product
BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 155140-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 155142-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 155143-01 BD PYXI
Category
Medical Device
Distribution
32 states
HighFDA (Devices)·Z-1537-2025·2025-04-16
Stryker Blueprint Mixed Reality Instrument Check Block Recall
Tornier S.A.S. is recalling the Stryker Blueprint Mixed Reality Instrument Check Block (Catalog Number MRUE203) due to an elevated complaint rate involving software and instrumentation malfunctions that prevent the system from functioning as intended.
Product
stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1547-2025·2025-04-16
Medline ReNewal Coblator II ENT Device Drip Chamber Disconnection Risk
Medline is recalling 20 units of ReNewal Coblator II ENT devices because drip chambers may disconnect from saline tubing under tension, potentially disrupting fluid delivery during procedures.
Product
MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

4176–4200 of 39968