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

2801–2825 of 27346

HighFDA (Devices)·Z-1600-2025·2025-04-23
Medline sterile surgical convenience kits with potentially weak seals
Medline Industries is recalling 33 models of sterile surgical convenience kits due to potential open or weak seals on breather pouches used for packaging. The defect may compromise sterility of the kits.
Product
Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 2) PLASTIC PACK, Model Number: DYNJ65109; 3) PLASTIC PROCEDURE PACK, Model Number: DYNJ34160D; 4) MINOR BREAST SJHC-LF, Model Number: DYNJ84991; 5) PLASTIC PACK, Mo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1599-2025·2025-04-23
Medline Convenience Kits Recalled for Potential Weak Seals
Medline Industries is recalling select sterile convenience kits due to a potential for open or weak seals on the breather pouches used for packaging. The affected kits are distributed nationwide and in Canada, Mexico, Panama, and the Virgin Islands.
Product
Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A; 2) TRAY ADD A CATH FOL UM MF 10ML, Model Number: DYND150200S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1594-2025·2025-04-23
Medline sterile convenience kits recalled for potential weak breather pouch seals
Medline Industries is recalling ten models of sterile convenience kits used for various medical procedures due to potential open or weak seals on breather pouches. The seal failure could compromise sterility of the kits.
Product
Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX, Model Number: DYNJ68393A; 2) SOFT TISSUE BIOPSY PACK, Model Number: DYNJ81441B; 3) BILAT TESTICULAR SPERM EXTRACT, Model Number: DYNJ68303; 4) PROCEDURE MINEURE BJC-LF, Model Number: DYNJ41678B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1608-2025·2025-04-23
Medline Convenience Kit Drape Packs Recalled for Weak Seal Risk
Medline Industries is recalling UNIVERSAL DRAPE PACK convenience kits because their breather pouches may have open or weak seals, potentially compromising sterility of the packaged kits.
Product
Medline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PACK, Model Number: DYNJCD0239
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1596-2025·2025-04-23
Medline Rhinoplasty Pack kits recalled for potential breather pouch seal failures
Medline is recalling Rhinoplasty Pack convenience kits (Model DYNJ27333F) due to potential open or weak seals on breather pouches used to package the sterile kits.
Product
Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ27333F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1552-2025·2025-04-23
BD Pyxis MedBank Receiving Cabinet Software Medication Dispensing Safety Issue
CareFusion 303 is recalling certain BD Pyxis MedBank Receiving Cabinet Software versions because a "Clear All" function may bypass pharmacist validation, potentially allowing incorrect medication dispensing without authorization.
Product
MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK MINI MAIN, REF: 1147-00 BD PYXIS MEDBANK Facility Software, REF: 139090-01; BD PYXS MEDBNK TWR MN 2HH1FH2HM2FM2FG1FF, REF: 169-100; BD PYXIS MEDBANK MINI 1HH-1F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1555-2025·2025-04-23
GE Venue Go Ultrasound Systems Battery Risk Recall
GE Medical Systems is recalling certain Venue Go ultrasound system models worldwide due to potential battery internal failure that could result in smoke or fire.
Product
Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VGW), R3 Surgery for China (Model Number H45113VGSU), R3 PeriOP for China (Model Number H45113VGPO), R3 Expert for China (Model Number H45113VGEX
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1595-2025·2025-04-23
Medline dental convenience kits recalled for potential weak seal packaging
Medline is recalling five models of dental convenience kits due to the potential for open or weak seals on the breather pouches used for packaging. The affected sterile kits were distributed nationwide in the US and internationally.
Product
Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880; 2) DENTAL PACK, Model Number: DYNJ56229A; 3) DENTAL PACK-LF, Model Number: PHS807626F; 4) DENTAL PACK SMGH, Model Number: DYNJ41929D; 5) DENTAL PACK, Model Number: DYNJ51841
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1592-2025·2025-04-23
Medline Sterile Convenience Kits Recalled for Potential Weak Seals
Medline Industries is recalling multiple sterile surgical convenience kits because purchased breather pouches used in packaging may have open or weak seals, which could compromise sterility.
Product
Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model Number: DYNJ59310D; 2) CARDIAC STERNAL PACK, Model Number: DYNJ32436A; 3) VEIN CLOSURE PACK, Model Number: DYNJ35586G; 4) ABLATION PACK-LF, Model Number: DYNJ55343B; 5) ABLATION PACK-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1611-2025·2025-04-23
Medline Convenience Kits for Obstetrical Procedures Recalled for Weak Seals
Medline Industries is recalling 21,935 units of sterile convenience kits used for labor, delivery, and vaginal delivery procedures due to potential open or weak seals on breather pouches. The defective packaging could compromise product sterility.
Product
Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ0378319P; 3) VUWC OB PACK, Model Number: DYNJ64017B; 4) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A; 5
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1612-2025·2025-04-23
Medline Convenience Kits Recalled for Potential Open Breather Pouch Seals
Medline Industries is recalling select sterile convenience kits (Model DYNJ80807B, Lot 24IBH993) due to potential open or weak seals on breather pouches used for packaging. Compromised seals may affect product sterility.
Product
Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1614-2025·2025-04-23
Medline Sterile Procedure Kits recalled for potential seal issues
Medline Industries is recalling multiple sterile procedure kits due to potential open or weak seals on breather pouches used for packaging. The affected kits were distributed worldwide including the US and several other countries.
Product
Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A; 2) C-SECTION PCH-LF, Model Number: DYNJ81281; 3) C-SECTION PACK-LF, Model Number: OBK387M; 4) C-SECTION PCH-LF, Model Number: DYNJ81281; 5) NHS - C-SECTION SCG, Mod
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1586-2025·2025-04-23
Medline Intubation Tray Convenience Kits Recalled for Weak Breather Pouch Seals
Medline Industries is recalling select Intubation Tray convenience kits (Model MNS10395, Lot 24KBI045) due to potential open or weak seals on breather pouches used for packaging. Weak seals may compromise product sterility.
Product
Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Model Number: MNS10395;
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-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-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-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-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-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-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-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-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-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-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

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2801–2825 of 27346