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.

5926–5950 of 52958

HighFDA (Devices)·Z-0748-2025·2025-01-01
BD FACSLyric Flow Cytometer Power Supply Module Failure Risk
BD is recalling power supply modules on FACSLyric flow cytometers that may fail to power on or stay on. Failure could cause lab staff to inhale fumes and patients to need repeat blood draws.
Product
FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath ta
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0727-2025·2025-01-01
Cardiac troponin test reagent recalled for potential false results
Beckman Coulter recalls 2.1 million units of Access hsTnI reagent worldwide due to contamination causing falsely elevated troponin results in patient samples.
Product
Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0741-2025·2025-01-01
Siemens epoc blood analyzer software assigns incorrect patient names
Siemens epoc NXS blood analysis system has a software defect that can incorrectly assign patient names to blood test results, potentially causing misdiagnosis or mistreatment.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0745-2025·2025-01-01
BD FACSLyric 2L4C Flow Cytometer Power Supply Failure Recall
BD FACSLyric 2L4C flow cytometers with specific power supplies (part 650781) may fail to power on or stay on. Potential fume inhalation could cause respiratory symptoms in laboratory staff.
Product
FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for in vitro diagnostic for the following: " Immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0722-2025·2025-01-01
Surgical Patties and Strips Recalled for Elevated Endotoxin Levels in Kits
Medline Industries is recalling SEPTOPLASTY PACK convenience kits nationwide due to higher-than-expected endotoxin levels in surgical patties and strips. The contamination may pose infection risks during surgical procedures.
Product
SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0766-2025·2025-01-01
EMPOWR 3D Knee Tibial Insert Package Mix-Up Causes Surgical Delays
Encore Medical recalls EMPOWR 3D Knee Tibial Insert packages that may contain the wrong size implant (5R 16MM with 3R 14MM and vice versa), potentially delaying surgery. The recall affects 33 units nationwide.
Product
EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0720-2025·2025-01-01
Medline surgical procedure kits recalled due to endotoxin contamination
Medline brand surgical procedure convenience kits in specific lots contain higher-than-expected endotoxin levels in surgical patties and strips. The contamination was found in raw materials used to produce sterile components.
Product
Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU DYNJ33520A; 4) SINUS PACK, SKU DYNJ44845G; 5) SINUS PACK, SKU DYNJ48330B; 6) ENT PACK, SKU DYNJ50572; 7) ENT PACK, SKU DYNJ53573A; 8
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0738-2025·2025-01-01
Siemens Blood Analysis System Software Malfunction May Cause Patient Identification Error
Siemens epoc NXS Host blood analysis systems are recalled due to a software malfunction that can assign incorrect patient names to blood tests, potentially leading to misdiagnosis or mistreatment.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0737-2025·2025-01-01
Blood Analysis System Software Malfunction May Assign Incorrect Patient Names
Siemens epoc NXS Host blood analysis systems contain a software malfunction that may assign incorrect patient names to blood measurements. This could result in clinicians making treatment decisions based on the wrong patient's test results.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0759-2025·2025-01-01
Medline ST IUD Removal Hook Recalled Due to Weak Seals and Sterility Risk
Medline Industries is recalling 21,440 units of the ST IUD Removal Hook due to weak seals that may compromise sterility. The defect is undetectable to users and could increase infection risk.
Product
ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0719-2025·2025-01-01
Surgical Patties and Strips Recalled for Endotoxin Contamination
Medline Industries recalls DIEP FLAP Convenience kits containing surgical patties and strips due to higher-than-expected endotoxin contamination that may not meet sterile product specifications.
Product
DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0743-2025·2025-01-01
3M Clarity Precision Orthodontic Attachments Recall for Improper Tooth Mating
3M is recalling Clarity Precision Grip Attachments due to a design defect that may prevent proper fitting with digital treatment plans. The recall affects 171 orders distributed in the US, Canada, Australia, and New Zealand.
Product
Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832 359-833 359-834 359-835 359-836 359-837
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0317-2025·2025-01-01
BORSARI Bloody Mary Mix Recalled for Undeclared Fish and Soy Allergens
Borsari Food Company Inc is recalling BORSARI Bloody Mary Mix (32 fl. oz.) due to undeclared fish (anchovy) and soy. The product was distributed across multiple states, and consumers should not consume it.
Product
BORSARI Food Company Incorporated; BLOODY MARY MIX ; 32 FL. OZ; INGREDIENTS: Tomato juice, corn syrup, non-fat milk solids, orange juice, lemon juice, lime juice, cayenne pepper, vinegar, salt, garlic powder, Worcestershire sauce, prepared horseradish, maltic acid, sodium and pot
Category
Food
Distribution
25 states
HighFDA (Devices)·Z-0752-2025·2025-01-01
FDA Recalls Medical Spine Component Due to Manufacturing Defects
SEASPINE Orthopedics is recalling 191 Daytona Small Stature Ti Locking Caps due to manufacturing defects that prevent proper component mating.
Product
Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 Software Version: N/A Product Description: Locking Cap Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0721-2025·2025-01-01
Medline Surgical Patties and Strips Recalled for Endotoxin Contamination
Medline recalls surgical patties and strips from specific kit lots due to higher-than-expected endotoxin levels. The 318 kits were distributed in the United States and Canada.
Product
Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0316-2025·2025-01-01
ZOE Daily 30+ Prebiotic Blend Recalled for Possible Foreign Objects
ZOE brand Daily 30+ Prebiotic blend dietary supplements may contain small metal pieces or stones. Consumers should stop using affected batches and contact the manufacturer.
Product
ZOE brand Daily 30+ Prebiotic blend; Dietary Supplement; 500g resealable pouch
Category
Food
Distribution
26 states
HighFDA (Devices)·Z-0749-2025·2025-01-01
BD FACSLyric Flow Cytometer Power Supply Failure Risk
BD is recalling FACSLyric flow cytometer power supplies that may fail to power on or stay on, creating risks of fume inhalation and requiring patients to return for repeat biospecimen collection procedures.
Product
FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0732-2025·2025-01-01
Abbott Vascular Inflation Device May Leak During Cardiovascular Procedures
Abbott Vascular is recalling the 20/30 Priority Pack Accessory Kit w/Copilot inflation device used in cardiovascular procedures because it may leak at connection points, potentially causing air embolism.
Product
20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.
Category
Medical Device
Distribution
40 states
HighFDA (Drugs)·D-0156-2025·2025-01-01
Duloxetine Delayed-Release Capsules Recalled Due to N-nitroso Impurity Contamination
Amerisource Health Services is recalling certain lots of Duloxetine Delayed-Release Capsules due to N-nitroso impurity levels exceeding recommended limits. Consumers with the medication should contact their healthcare provider.
Product
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0694-2025·2025-01-01
Panther Fusion Assay Kit Recalled for Possible SARS-CoV-2 False Positives
Hologic is recalling specific lots of the Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay due to potential false positive SARS-CoV-2 results. Users should verify positive results with an alternative testing method.
Product
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0760-2025·2025-01-01
RUMMELL Medline Medical Device Weak Seals Sterility Risk Recall
Medline RUMMELL units may have weak seals that could compromise sterility and increase infection risk. Approximately 21,440 units distributed nationwide are affected.
Product
RUMMELL, Medline Item No. ST006ST
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0157-2025·2025-01-01
Duloxetine Delayed-Release 60 mg Capsules Recalled for N-Nitroso Impurity
Amerisource Health Services is recalling Duloxetine Delayed-Release Capsules 60 mg due to N-nitroso impurity levels exceeding FDA recommended limits. The recall affects 20,734 bottles distributed nationwide.
Product
Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04
Category
Drug
Distribution
Distributed nationwide
HighCPSC·25077·2024-12-26
Avalanche Transceivers Recalled for Battery Contact Failure Risk
Black Diamond recalls 770 PIEPS Pro IPS Avalanche Transceivers due to battery contact failure that could prevent operation during emergencies. Units were sold from February through November 2024 for $530–$620.
Product
PIEPS Pro IPS Avalanche Transceivers
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·25079·2024-12-26
GIKPAL 12-Drawer Dressers Recalled for Tip-Over and Entrapment Hazards
GIKPAL 12-Drawer Dressers are being recalled because they can tip over and trap children if not anchored to a wall. About 800 units were sold on Walmart.com; consumers should stop using them and contact ONME Direct for a refund.
Product
GIKPAL 12-Drawer Dressers
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0706-2025·2024-12-25
GE OEC 9800 X-Ray System Recalled for Insufficient Tube Sealing
GE OEC 9800 fluoroscopic X-ray systems are recalled due to insufficient sealing of X-ray tubes, which can result in oil leaks and loss of imaging capability. 25 systems distributed in the U.S. and internationally are affected.
Product
OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscop
Category
Medical Device
Distribution
45 states