April 2025 recalls

547 recalls were announced in April 2025.

What the numbers show

Critical: 1
Severe: 125
High: 277
Moderate: 138
Low: 6

Of the 547 recalls this month scored against our rubric, 0% are Critical, 23% are Severe.

Which agencies issued them

101–200 of 547

CriticalFDA (Devices)·Z-1533-2025·2025-04-23
AutoPulse NXT Resuscitation System may fail to provide chest compressions
ZOLL Circulation, Inc. is recalling the AutoPulse NXT Resuscitation System Model 200 because the device may not provide adequate chest compressions or may stop compressions due to an error code FC1060.
Product
Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, bat
Category
Medical Device
Distribution
19 states
SevereFDA (Devices)·Z-1524-2025·2025-04-23
Ballard Closed Suction Catheters recalled for sterility assurance failure
Avanos Medical is recalling Ballard Closed Suction Catheters (Model 220135) due to lack of sterility assurance. The recall affects 9,020 units distributed nationwide and internationally.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, T-Piece Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1526-2025·2025-04-23
Ballard Closed Suction Catheters recalled due to sterility assurance failure
Avanos Medical is recalling 1,420 units of Ballard Closed Suction Catheters (Model 2271418-5) due to lack of sterility assurance. The affected product was distributed worldwide, including across the US and internationally.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 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
SevereNHTSA·25V272000·2025-04-23
Ford Recalls 2022-2023 F-150 Lightning Vehicles Due to Battery Fire Risk
Ford is recalling 2022-2023 F-150 Lightning vehicles because loose battery fasteners may cause electrical arcing, increasing the risk of fire or loss of drive power.
Product
FORD — FORD F-150 LIGHTNING BEV
Category
Vehicle
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-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-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
SevereFDA (Drugs)·D-0365-2025·2025-04-23
Levetiracetam Injection Label Mismatch Nationwide Recall
Dr. Reddy's Laboratories is recalling Levetiracetam 0.75% Sodium Chloride Injection due to a labeling discrepancy where the infusion bag is incorrectly labeled as 0.82% Sodium Chloride 500 mg/100 mL instead of the correct 0.75% Sodium Chloride 1,000 mg/100 mL.
Product
LEVETIRACETAM — LEVETIRACETAM (LEVETIRACETAM INJECTION)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1520-2025·2025-04-23
Tandem Mobi Insulin Pump Software Defect Risks Incorrect Insulin Delivery
Tandem Diabetes Care is recalling Tandem Mobi Insulin Pumps with software version 7.9 due to a defect that can cause incorrect insulin delivery when glucose data gaps occur, potentially leading to severe high or low blood sugar.
Product
Tandem Mobi Insulin Pump with Interoperable Technology
Category
Medical Device
Distribution
29 states
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-1525-2025·2025-04-23
Ballard Closed Suction Catheters recalled for lack of sterility assurance
Avanos Medical is recalling Ballard Closed Suction Catheters (Model 2210-5) because they lack adequate sterility assurance. The recall affects approximately 2,080 units distributed worldwide, including across most US states and several countries.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE Component: N/A
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-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-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-1521-2025·2025-04-23
Ballard Closed Suction Catheters recalled for lack of sterility assurance
Avanos Medical is recalling Ballard Closed Suction Catheters (Model 198, 8 F, Y-Adapter) for neonates and pediatrics due to lack of sterility assurance. The recall affects 1,980 units distributed nationwide and internationally.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter Component: No
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 (Food)·F-0706-2025·2025-04-23
Marketside Brand Celery Sticks Recalled for Listeria Monocytogenes
Marketside brand celery sticks (1.6 oz) have been recalled due to Listeria monocytogenes contamination. Duda Farm Fresh Foods, Inc. is recalling approximately 1,587 cases distributed nationwide.
Product
Marketside brand celery stick. Net wt. 1.6 OZ. (45g); Rear panel: 1 serving per container; Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 UPC# 6 81131 16151 0
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1570-2025·2025-04-23
HeartMate Mobile Power Unit electrical malfunction may cause loss of power
Thoratec LLC is recalling HeartMate Mobile Power Units due to an electrical component defect that may prevent the unit from turning on, cause unprompted shut down, or trigger false alarms. If power is lost and not switched to rechargeable batteries within 15 minutes, the connected pump may lose power.
Product
HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1522-2025·2025-04-23
Ballard Closed Suction Catheters recalled for lack of sterility assurance
Avanos Medical is recalling Ballard Closed Suction Catheters (Model 210, 10 F Elbow) for neonates and pediatric patients due to lack of sterility assurance. Approximately 4,000 units were distributed worldwide.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow Component: N/A
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
HighFDA (Food)·F-0725-2025·2025-04-23
Rolled Oats Recalled Due to Potential Plastic Foreign Material
Grain Millers Inc is recalling bulk rolled oats distributed in California and Indiana due to potential plastic foreign material contamination.
Product
Rolled Oats packaged in Bulk Poly Supersacks packaged and labeled as follows: 1. 1800 LB Regular Rolled Oats #5, Weight: 1800.00 lb. Product ID: 810239153. Grain Millers, 1 Grain Millers Drive, Yorkton, SK S3N 3Z4. Product of Canada. 2. 1600 LB Quick Rolled Oats #21, W
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-1615-2025·2025-04-23
Medline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals
Medline Industries is recalling multiple sterile surgical convenience kits due to potential open or weak seals on the breather pouches used for packaging. The compromised seals could affect product sterility.
Product
Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Model Number: DYNJ80786; 2) D & C HYSTEROSCOPY PACK, Model Number: DYNJ21937J; 3) VAGINAL HYSTERECTOMY WRH-LF, Model Number: DYNJ41949B; 4) HYSTER/RESECTOSCOPE #78-RF, Model Number: DYNJ21824R; 5) PE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1621-2025·2025-04-23
Guide Wire with Ruler Tube metal ring detachment recall
Stryker GmbH is recalling Guide Wire with Ruler Tube 3x1000 mm DIA devices because the metal ring at the end may detach during surgery.
Product
Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;
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-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-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-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
HighNHTSA·25V270000·2025-04-23
Ford Recalls 2015 Models for Rearview Camera Defect
Ford is recalling 2015 F-Series, Expedition, Navigator, and MKC vehicles because a loose rearview camera connector may cause a blank or distorted image, increasing crash risk.
Product
FORD — FORD, LINCOLN redundant F-350, F-450, redundant F-250, MKC
Category
Vehicle
Distribution
Distributed nationwide
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 (Food)·F-0704-2025·2025-04-23
Trader Joe's Hot Honey Mustard Dressing Recalled for Undeclared Allergens
Trader Joe's Hot Honey Mustard Dressing (12 fl. oz., Use By Date 5/27/25) is being recalled because bottles labeled as Hot Honey Mustard actually contain Thai Style Peanut Dressing with undeclared peanuts, soy, sesame, and wheat.
Product
Trader Joe's Hot Honey Mustard Dressing (SKU #80152), packaged in glass bottle with tamper overwrap on plastic cap, net wt. 12 fl. oz. UPC 0080 1522. DIST. & SOLD Exclusively by: Trader Joe's Monrovia, CA. These 12oz. bottles were sold directly to consumers. The master cases we
Category
Food
Distribution
18 states
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-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-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-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-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 (Food)·F-0707-2025·2025-04-23
Falafel King Hummus Recalled for Undeclared Sesame Allergen
Falafel King Enterprises is recalling Traditional Hummus in 13 oz multi-component containers because the label declares tahini paste but fails to declare sesame, a common allergen.
Product
Falafel King Taste the Mediterranean is a multi-component, 4 section plastic container, that includes Traditional Hummus, Falafel Balls, Tzatziki, and Mixed Vegetables. " Net Wt: 13 oz. UPC 82298621035 4. The Traditional Hummus is the recalled product and the ingredient statemen
Category
Food
Distribution
1 state
HighFDA (Food)·F-0713-2025·2025-04-23
Tony's Chocolonely Everything Bar recalled for foreign objects
Tony's Chocolonely Inc is recalling Tony's Chocolonely Everything Bar products nationwide due to the presence of stones in the chocolate bars.
Product
Tony's Chocolonely Everything Bar
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0710-2025·2025-04-23
Salvadorena Quesadilla de Queso Recalled for Undeclared Milk
Panaderia Salvadorena Ii is recalling Quesadilla de Queso products that contain undeclared milk, a common allergen that poses a risk to consumers with milk allergies.
Product
PANADERIA/BAKERY Salvadorena; Quesadilla de Queso; Ingredients: Rice, Wheat Flour, soy, eggs, sugar, butter, baking powder, salt, water, sour cream, sesame seeds; UPC 0 21651 16499 6; NET WEIGHT APPROX 14 OZ
Category
Food
Distribution
2 states
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-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-1557-2025·2025-04-23
Abbott Aveir DR Leadless Pacemaker Recalled for Battery Failure Risk
Abbott Medical is recalling specific Aveir DR Leadless Pacemaker devices due to manufacturing exposure to higher-than-normal temperatures that may cause premature battery failure.
Product
Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s) of
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-1569-2025·2025-04-23
Conformis Restor3d Cordera Hip Acetabular Liner Mislabeled
Conformis is recalling certain Cordera Hip acetabular liners from Lot 1788258 due to incorrect labeling. Units labeled as standard liners actually contain hooded liners, creating a mismatch between the label and the product.
Product
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
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-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-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-1604-2025·2025-04-23
Medline Convenience Kits Recalled for Potential Breather Pouch Seal Defects
Medline is recalling select IV convenience kits due to potential open or weak seals on breather pouches used for packaging. The defective seals may compromise sterility of the medical devices.
Product
Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Model Number: DYNJ88422
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1610-2025·2025-04-23
Medline Sterile Convenience Kits Recalled for Breather Pouch Sealing Defect
Medline Industries has recalled five sterile convenience kits for various neurosurgical and implant procedures due to potential open or weak seals on breather pouches used in packaging. The defect could compromise sterility of the devices.
Product
Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT PACK, Model Number: DYNJ53032C; 3) WMC VP SHUNT PACK-LF, Model Number: DYNJ50629M; 4) SHUNT PACK, Model Number: DYNJ40040C; 5) STIM IMPLANT PACK, Model N
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0708-2025·2025-04-23
Arepas de Chocolo recalled for undeclared soy allergen
Delicias de la Abuela Inc. is recalling Arepas de Chocolo due to the presence of undeclared soy lecithin. Consumers with soy allergies should not consume this product.
Product
Arepas de Chocolo, Abuelas Food Company, Delicias de la Abuela's, Net Weight: 22.5oz. (638g), 5 units per package, Vacuum seal packages and twist tie bags, KEEP REFRIGERATED. UPC 850283002037
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1564-2025·2025-04-23
Welch Allyn Connex Vital Signs Monitor Recall: Undeclared Natural Rubber
Baxter Healthcare Corporation is recalling certain Welch Allyn Connex Vital Signs Monitors due to an undeclared natural rubber band in the packaging of reusable blood pressure cuffs. The undeclared rubber may pose an allergen risk to individuals with natural rubber latex sensitivity.
Product
Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Product Code/Part # 67MXTX-B; 3) ) Product Code/Part # 67MXXP-B; 4) ) Product Code/Part # 67MXXX-B; 5) ) Product Code/Part # 67NCTP-B; 6) ) Product Code/P
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1553-2025·2025-04-23
Philips DXR System X-Ray Equipment Collimator Fall Hazard Recall
Philips is recalling certain DXR System DuraDiagnost 4.1 stationary X-ray systems due to a potential for the collimator to fall if installed incorrectly.
Product
Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1568-2025·2025-04-23
Welch Allyn Reusable Blood Pressure Cuff Kits Recalled for Undeclared Rubber
Baxter Healthcare Corporation is recalling Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits worldwide due to undeclared natural rubber in the packaging. Consumers with latex allergies may experience allergic reactions if exposed.
Product
Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff Kits, Product Code/Part Numbers: 2. WELCH ALLYN Reusable Blood Pressure Cuff Kit, Product Code/Part Numbers: 410519, 5090-41, 5098-20.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1556-2025·2025-04-23
GE Venue Fit ultrasound systems battery fire hazard recall
GE Medical Systems is recalling certain Venue Fit ultrasound systems because the battery can develop an internal failure that could result in smoke or fire.
Product
Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45335VFS, H45335VFSW), R3 Surgery for China, R3 PeriOP for China, R3 Expert for China, R3 Pro for China, R3 Performance for China, R3 Intervent
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1617-2025·2025-04-23
Medline Sterile Ophthalmic Convenience Kits Recalled for Weak Breather Pouches
Medline Industries is recalling select sterile ophthalmic convenience kits due to potential open or weak seals on breather pouches used for packaging. The kits are used for various eye procedures.
Product
Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097A; 2) PK EYE, Model Number: DYNJ60631B; 3) CATARACT PACK, Model Number: DYNJ80316A; 4) BASIC EYE PACK, Model Number: DYNJ63707C; 5) EYE PACK WITH ACCESSORY PACK, Model Number:
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1588-2025·2025-04-23
Medline sterile convenience kits recalled for weak breather pouch seals
Medline is recalling two models of sterile convenience kits (PAIN PACK and PAIN TRIAL PACK) due to potential open or weak seals on breather pouches used in the packaging.
Product
Medline Convenience kits used for various procedures: 1) PAIN PACK, Model Number: DYNJ67577A; 2) PAIN TRIAL PACK, Model Number: DYNJ67576A;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1591-2025·2025-04-23
Medline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals
Medline Industries is recalling sterile convenience kits for various medical procedures due to potential open or weak seals on breather pouches used in product packaging.
Product
Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 2) ENSEMBLE CORONAROGRAPHIE-LF, Model Number: DYNJ64354A; 3) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D; 4) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B; 5) CATH
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1620-2025·2025-04-23
Guide Wire with Ruler Tube 3x800 mm Metal Ring Detachment Recall
Stryker GmbH is recalling the Guide Wire with Ruler Tube 3x800 mm DIA because the metal ring at the end may detach during surgery. The defect could interfere with the surgical procedure.
Product
Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1589-2025·2025-04-23
Medline Convenience Kits Recalled for Potential Open or Weak Seals
Medline Industries is recalling select sterile convenience kits due to potential open or weak seals on breather pouches used for packaging. The defect may compromise product sterility.
Product
Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF, Model Number: DYNJ0371999G;
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
HighFDA (Devices)·Z-1593-2025·2025-04-23
Medline Convenience Kits Recalled Due to Weak Breather Pouch Seals
Medline Industries is recalling multiple convenience kit models due to potential open or weak seals on breather pouches used for packaging. The compromised seals may allow sterility to be compromised on these medical device kits distributed nationwide and internationally.
Product
Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model Number: DYNJ44949C; 2) PICC LINE INSERTION BJC-LF, Model Number: DYNJ41682C; 3) SUPERFICIAL VENOUS PROCEDURE, Model Number: DYNJ81267A; 4) ILR INSERTION-REMOVAL PACK, Model Number: DYNJ8243
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1618-2025·2025-04-23
Medline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals
Medline Industries is recalling sterile convenience kits with select breather pouches that may have open or weak seals, potentially compromising sterility. Affected units were distributed worldwide, including the US, Canada, Mexico, Panama, and the Virgin Islands.
Product
Refer to RES
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
ModerateFDA (Devices)·Z-1576-2025·2025-04-23
ID NOW RSV 24T Respiratory Virus Panel Has Higher Invalid Test Rates
Abbott Diagnostics is recalling specific lots of the ID NOW RSV 24T respiratory virus assay due to higher-than-expected invalid test rates. The affected lots were distributed nationwide.
Product
Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0714-2025·2025-04-23
Tony's Chocolonely Dark Chocolate Almond Sea Salt recalled for foreign objects
Tony's Chocolonely Dark Chocolate Almond Sea Salt is being recalled nationwide because some units contain stones. Consumers who have purchased affected lots should not consume the product.
Product
Tony's Chocolonely Dark Chocolate Almond Sea Salt
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1574-2025·2025-04-23
ID NOW COVID-19 2.0 24T Point-of-Care Device Recall
Abbott Diagnostics is recalling certain lots of the ID NOW COVID-19 2.0 24T test device due to higher-than-expected rates of invalid test results. The affected devices were distributed nationwide.
Product
Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1602-2025·2025-04-23
Sterile convenience kits recalled for potentially weak breather pouch seals
Medline Industries is recalling sterile convenience kits due to potential open or weak seals on breather pouches used in packaging. Defective seals may compromise product sterility.
Product
Refer to RES
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1571-2025·2025-04-23
ID NOW COVID-19 2.0 Point-of-Care Test Device Recall
Abbott is recalling certain lots of the ID NOW COVID-19 2.0 24T test device due to higher invalid result rates than stated in product instructions. The affected lots were distributed worldwide.
Product
Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1577-2025·2025-04-23
Maquet VH-3010 Power Supply Recalled for Inadequate Heating Function
Maquet Cardiovascular is recalling 110 units of the VH-3010 Power Supply due to an incorrect resistor that may prevent the HemoPro 2 harvesting tool jaws from heating adequately.
Product
Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1573-2025·2025-04-23
ID NOW RSV 24T Respiratory Virus Assay System Higher Invalid Result Rates
Abbott Diagnostics is recalling certain lots of the ID NOW RSV 24T respiratory virus assay system due to higher-than-expected invalid result rates compared to the product instructions.
Product
Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1597-2025·2025-04-23
Medline Convenience Kits Recalled for Potentially Open Breather Pouches
Medline Industries is recalling select sterile convenience kits because purchased breather pouches used for packaging may have open or weak seals, potentially compromising the sterility of the kits.
Product
Medline Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model Number: DYNJ66514; 3) ENT PACK, Model Number: DYNJ67775A; 4) T/A ENDO PACK, Model Number: DYNJ83158; 5) T & A PACK, Model Number: DYNJ0634878I; 6) PPM-IC
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1619-2025·2025-04-23
Medline Sterile Convenience Kits Recalled for Open Breather Pouches
Medline Industries is recalling three models of sterile convenience kits used for arthroscopy procedures due to potential open or weak seals on the breather pouches used for packaging.
Product
Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF, Model Number: DYNJ40229A; 2) ARTHROSCOPY PACK-LF, Model Number: OPK382N; 3) ARTHROSCOPY NEW TEGH-LF, Model Number: DYNJ46723B
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 (Drugs)·D-0364-2025·2025-04-23
Ciprofloxacin Ophthalmic Solution Recalled for Defective Container Cap
Direct Rx is recalling Ciprofloxacin Ophthalmic Solution 0.3% because the cap spike may lodge in the bottle nozzle, preventing the medication from being dispensed.
Product
CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.
Category
Drug
Distribution
5 states
ModerateNHTSA·25V271000·2025-04-23
Ford Recalls 2025 F-150 Vehicles for Missing Air Bag Warning Labels
Ford is recalling 2025 F-150 vehicles because the air bag warning label may be missing from the dashboard, failing to comply with federal safety standards.
Product
FORD — FORD F-150
Category
Vehicle
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
ModerateFDA (Drugs)·D-0366-2025·2025-04-23
Chlorpromazine Hydrochloride Tablets Recalled Due to Impurity
The FDA is recalling Chlorpromazine Hydrochloride Tablets, 10 mg, due to the presence of N-Nitroso-Desmethyl Chlorpromazine impurity above recommended limits. The affected lot was distributed nationwide.
Product
ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0715-2025·2025-04-23
Tortilla Chips Recalled Due to Undeclared Yellow #5 Dye
La Mexicana Tortilla Factory is recalling Tortilla Chip Green 4 cut products due to undeclared Yellow #5, an FDA-certified colorant that poses a risk to consumers with dye sensitivities or allergies.
Product
Tortilla Chip Green 4 cut packed 5lbs per bag; 6 bags per box
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-0716-2025·2025-04-23
Golden Crop Candy Recalled for Undeclared Food Color Additives
Blooming Import Inc. is recalling Golden Crop Candy (10 oz. wrapped candies) because it contains undeclared and unallowed food color additives: Blue 1, Red 40, and Acid Red 18.
Product
Golden Crop Candy (10 oz. (283g) wrapped candies)
Category
Food
Distribution
8 states
ModerateFDA (Food)·F-0712-2025·2025-04-23
Lemon Plum product recall due to undeclared cyclamates
Rong Shing Trading NY Inc is recalling Lemon Plum (228g) because the product contains cyclamates, which are not declared on the label.
Product
LEMON PLUM; NET WT: 228G (8oz); INGREDIENTS: Plum, sugar, salt, lemon juice, food additives (citric acid, sodium benzoate, potassium sorbate, ethyl maltol, FD&C YELLOW#6, vanillin, saccharin sodium, sodium metabisulfite), food flavoring; DISTRIBUTED BY RONG SHING TRADING NY INC;
Category
Food
Distribution
5 states
ModerateFDA (Food)·F-0711-2025·2025-04-23
Legally Addictive O.G. Cookies recalled for rancid taste
Legally Addictive Foods is recalling Legally Addictive The O.G. Cookies in two sizes due to consumer complaints of rancid taste. The cookies were distributed in Illinois and Pennsylvania.
Product
LEGALLY ADDICTIVE THE O.G. COOKIES MADE FROM CRACKERS+TOFFEE+CHOCOLATE+SEA SALT NET WT. 4.7OZ (133G) UPC 8 54766 00802 8 & 1.34OZ (38G) UPC 8 54766 02800 4
Category
Food
Distribution
2 states
ModerateFDA (Devices)·Z-1606-2025·2025-04-23
Medline Convenience Kit Skin Lesion Set Potential Seal Defect
Medline is recalling its Skin Lesion Set convenience kits due to potential open or weak seals on breather pouches used for packaging. The compromised seals may affect the sterility of the kits.
Product
Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number: MNS6270
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-1598-2025·2025-04-23
Medline Sterile Convenience Kits Recalled for Defective Breather Pouches
Medline Industries is recalling select sterile convenience kits due to the potential for open or weak seals on breather pouches used in packaging. Affected units were distributed nationwide and internationally.
Product
Refer to RES
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0362-2025·2025-04-23
Unisom SleepMinis diphenhydramine capsules recalled for nitrosamine impurity
Chattem Inc. is recalling Unisom SleepMinis 25 mg diphenhydramine capsules due to detection of nitrosamine impurity above FDA limits. Affected lots are 22L603 (exp. Oct 2025) and 378999 (exp. Feb 2027).
Product
Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0363-2025·2025-04-23
Testosterone Cypionate Injection Recalled for Insoluble Crystals
Eugia US LLC is recalling Testosterone Cypionate Injection due to complaints that crystals do not redissolve into solution after warming and shaking. The defect may affect product safety and efficacy.
Product
TESTOSTERONE CYPIONATE — TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
Category
Drug
Distribution
Distributed nationwide
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-1565-2025·2025-04-23
Welch Allyn Spot Vital Signs 4400 Device Blood Pressure Cuff Recall
Baxter Healthcare Corporation is recalling certain Welch Allyn Spot Vital Signs 4400 blood pressure cuff devices due to undeclared natural rubber bands in the packaging, which poses an allergy risk.
Product
Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6; 5) 44WT-B; 6) 44XT-2; 7) 44XT-4; 8) 44XT-6; 9) 44XT-B.
Category
Medical Device
Distribution
0 states
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-1563-2025·2025-04-23
Welch Allyn Connex Spot Monitor blood pressure cuffs undeclared natural rubber
Baxter Healthcare is recalling certain Welch Allyn Connex Spot Monitor reusable blood pressure cuffs worldwide because packaging contains an undeclared natural rubber band that may trigger allergic reactions in sensitive individuals.
Product
Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74CX-B; 5) 74ME-B; 6) 74MT-B; 7) 74MX-B; 8) 74RE-B; 9) 74RT-B; 10) 75CE-B; 11) 75CT-B; 12) 75CT-BR; 13) 75CX-B; 14) 75-HCA-CTB; 15) 75-HCA-M
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1578-2025·2025-04-23
Rover Mobile X-ray System Recalled for Potential Early Tube Failure
Micro-X Ltd. is recalling 31 Rover Mobile X-ray Systems (Model MXU-RV71) due to potential early life failure of the x-ray tube caused by excessive thermal load on the anode. The systems were distributed nationwide in California, New Jersey, and Puerto Rico.
Product
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 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
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 (Food)·F-0717-2025·2025-04-23
Golden Crop Candy contains undeclared food color additives
Blooming Import Inc. is recalling Golden Crop Candy (8 oz unwrapped) due to undeclared and unallowed color additives: Blue 1, Red 40, and Acid Red 18.
Product
Golden Crop Candy (8 oz. (227g) un-wrapped candies)
Category
Food
Distribution
8 states
ModerateFDA (Devices)·Z-1567-2025·2025-04-23
Welch Allyn DuraShock Aneroid Gauge Sets Reusable Blood Pressure Cuff Recall
Baxter Healthcare Corporation is recalling certain Welch Allyn DuraShock Aneroid Gauge Sets with reusable blood pressure cuffs due to undeclared natural rubber band in the packaging. This poses a risk to individuals with rubber allergies.
Product
Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Aneroid Gauge Sets with a Reusable Blood Pressure Cuff, Product Code Part Numbers: 5098-02, 5098-23, 5098-27, 5098-28, 5098-29, 5098-30, 5098-33, 5098-42, DS44-
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1572-2025·2025-04-23
ID NOW Influenza A/B 2 24T Diagnostic Assay Invalid Result Rates
Abbott Diagnostics is recalling certain lots of the ID NOW Influenza A/B 2 24T diagnostic assay due to higher-than-expected invalid test result rates. Affected lots were distributed worldwide.
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
LowFDA (Food)·F-0705-2025·2025-04-23
Dried Seedless Plum Candy Recalled Due to Undeclared Cyclamates
BaiWei ShanZhuang Dried Seedless Plum Candy is being recalled because it contains cyclamates, which are not declared on the label. The product was distributed across multiple states.
Product
BaiWei ShanZhuang, Dried Seedless Plum Candy, 9.16 oz. (260g), plastic bags, 30 bags per case.
Category
Food
Distribution
11 states
LowFDA (Food)·F-0703-2025·2025-04-23
Farmer House Preserve Olive Strips recalled for undeclared cyclamates
Lins Waha International Corp is recalling Farmer House Preserve Olive Strips due to the presence of cyclamates, which are not permitted food additives in the United States.
Product
Farmer House Preserve Olive Strips
Category
Food
Distribution
18 states

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