Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

4651–4675 of 52939

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 (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 (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 (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-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-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-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-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-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-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-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-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 (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-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 (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-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-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-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-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-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