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

4051–4075 of 39824

SevereFDA (Devices)·Z-1584-2025·2025-04-23
Cerene Cryotherapy Device recalled for defective gasket seal
Channel Medsystems is recalling the Cerene Cryotherapy Device (Model FGS-7000) due to a defective evaporator gasket that may fail to seal, causing liquid nitrous oxide to leak during or after treatment.
Product
Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene Cryotherapy Device is an endometrial ablation device that uses nitrous oxide (N2O) to freeze and ablate the endometrium to r
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1507-2025·2025-04-23
BD 4 Fr Single-Lumen PowerPICC Catheters Recall Risk of Leaks
Bard Access Systems is recalling BD 4 Fr Single-Lumen PowerPICC Catheters worldwide because tubing material may exceed specifications, causing leaks and potentially serious complications including infection and air embolism.
Product
BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 2174108, 9194118, 3194118, 1174118, CK000285C, CK000335A, CK000796, 1194108D, CK000
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1560-2025·2025-04-23
Welch Allyn CP150 Electrocardiograph Recall Due to Battery Fire Risk
Baxter Healthcare is recalling Welch Allyn CP150 Electrocardiographs worldwide due to reports of battery-related fires. The fires occurred when devices used non-approved, third-party aftermarket batteries.
Product
Welch Allyn CP150 Electrocardiograph:
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1523-2025·2025-04-23
Ballard Closed Suction Catheters Recalled for Lack of Sterility Assurance
Avanos Medical is recalling Ballard Closed Suction Catheters (Model 20083) due to lack of sterility assurance. The company has distributed approximately 9,960 units worldwide.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1527-2025·2025-04-23
Ballard Closed Suction Catheters lack sterility assurance
Avanos Medical is recalling Ballard Closed Suction Catheters (Model 227-5) due to lack of sterility assurance. The recall affects 1,040 units distributed nationwide and internationally.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1558-2025·2025-04-23
Welch Allyn Connex Vital Signs Monitors with Unapproved Batteries
Baxter Healthcare is recalling Welch Allyn Connex Vital Signs Monitors because some units experienced battery-related fires caused by unapproved third-party after-market batteries.
Product
Welch Allyn Connex Vital Signs Monitor (CVSM):
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1559-2025·2025-04-23
Welch Allyn CONNEX Power Management Stand Battery Fire Risk
Baxter Healthcare is recalling the Welch Allyn CONNEX Accessory Power Management Stand due to reports of battery-related fires caused by unapproved third-party batteries.
Product
Welch Allyn CONNEX Accessory Power Management Stand:
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1519-2025·2025-04-23
t:slim X2 Insulin Pump Software Defect Affecting Glucose Delivery
Tandem Diabetes Care is recalling 63 units of the t:slim X2 Insulin Pump with software version 7.9 due to a defect that can cause incorrect insulin delivery. The defect may lead to dangerous blood sugar levels when glucose monitoring loses connection.
Product
t:slim X2 Insulin Pump with Interoperable Technology
Category
Medical Device
Distribution
29 states
SevereFDA (Devices)·Z-1528-2025·2025-04-23
Ballard Closed Suction Catheters recalled for sterility assurance defect
Avanos Medical is recalling Ballard Closed Suction Catheters (Model 22714183-5) due to lack of sterility assurance. The affected lot was distributed nationwide and internationally.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A
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-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-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-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-1566-2025·2025-04-23
Welch Allyn Green Series 777 Blood Pressure Cuff Wall System Recall
Baxter Healthcare Corporation is recalling certain Welch Allyn Green Series 777 Wall System blood pressure cuffs due to undeclared natural rubber in packaging. The recall affects 135 units distributed worldwide.
Product
Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77791-2MP2X; 2) 77791-2MP2XL; 3) 77791-2MPX; 4) 77791-2MPX-HS; 5) 77791-2MPXL; 6) 77796-2MPX; 7) 77796-2MPXL.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1607-2025·2025-04-23
Medline pacemaker drape pack convenience kits recalled for seal defects
Medline is recalling its Custom Pacemaker Drape Pack (Model DYNJCD0339) due to potential weak or open seals on breather pouches used in sterile convenience kits.
Product
Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE PACK, Model Number: DYNJCD0339
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1561-2025·2025-04-23
TLX/TLC SP Guided Implant Driver missing laser marked depth markings
Straumann USA LLC is recalling TLX/TLC SP Guided Implant Driver units because they are missing laser marked depth markings, which may affect proper surgical placement.
Product
TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1562-2025·2025-04-23
Welch Allyn Connex Wall System blood pressure cuffs recalled for undeclared rubber
Baxter Healthcare is recalling certain Welch Allyn Connex Integrated Wall System blood pressure cuff configurations due to an undeclared natural rubber band in the packaging that may cause allergic reactions in individuals with latex sensitivity.
Product
Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2) 84MTVE2-6; 3) 84MTVE2-B; 4) 84MTVE2-US; 5) 84MTVEC-6; 6) 84MTVEC-B; 7) 84MTVEP-B; 8) 84MTVEX-4; 9) 84MTVX2-4; 10) 84MTVX2-6; 11) 84MTVX2-B; 12) 84MTVX2-US; 13) 84MTVX
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1590-2025·2025-04-23
Medline sterile convenience kits recalled for potentially weak packaging seals
Medline is recalling three sterile convenience kit models due to potentially open or weak seals on the breather pouches used for packaging. The affected kits are distributed worldwide, including the US, Canada, Mexico, Panama, and the Virgin Islands.
Product
Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ05350V; 3) ANGIOGRAPHY PACK, Model Number: DYNJ38144C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1554-2025·2025-04-23
Philips DXR System DuraDiagnost Rel. 4 X-Ray System Collimator Fall Risk
Philips is recalling 83 units of the DXR System, DuraDiagnost Rel. 4 stationary X-ray system due to potential for the collimator to fall if incorrectly installed. The defect could pose injury risk to patients or staff.
Product
Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1579-2025·2025-04-23
Rover Mobile X-ray System MXU-RV35 Early X-ray Tube Failure Risk
Micro-X Ltd. is recalling the Rover Mobile X-ray System (model MXU-RV35) due to the potential for early X-ray tube failure caused by excessive thermal load on the anode. The affected units were distributed nationwide in California, New Jersey, and Puerto Rico.
Product
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagn
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-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
HighFDA (Devices)·Z-1616-2025·2025-04-23
Medline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals
Medline Industries is recalling multiple sterile convenience kits used for obstetric and gynecological procedures due to potential weak or open seals on breather pouches, which could compromise product sterility.
Product
Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK, Model Number: DYNJ68673; 2) D AND C PACK, Model Number: DYNJ66290A; 3) D & C PACK-LF, Model Number: DYNJ24159C; 4) OB PACK, Model Number: DYNJ54484A; 5) PERI GYN-LF, Model Number: DYNJS3040;
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

4051–4075 of 39824