January 2025 recalls

559 recalls were announced in January 2025.

What the numbers show

Critical: 13
Severe: 104
High: 395
Moderate: 44
Low: 3

Of the 559 recalls this month scored against our rubric, 2% are Critical, 19% are Severe.

Which agencies issued them

501–559 of 559

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-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 (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-0723-2025·2025-01-01
Medline surgical patties and strips recalled for endotoxin contamination
Medline surgical patties and strips used in certain procedure convenience kits were found to contain higher-than-expected endotoxin levels that may exceed safety specifications. The affected kits were distributed nationwide and in Canada.
Product
Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU DYNJ21927Q; 3) MVFF/FIBU #54-RF, SKU DYNJ21927S; 3) NEURO PEDIATRIC, SKU DYNJ61607A; 4) CRANIOTOMY PACK, SKU DYNJ66419C; 5) LYMPHATIC BYPASS PACK, SKU DYNJ69907;
Category
Medical Device
Distribution
Distributed nationwide
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-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 (Drugs)·D-0155-2025·2025-01-01
Duloxetine Delayed-Release Capsules Recalled for Nitrosamine Impurity
Amerisource Health Services LLC is recalling Duloxetine Delayed-Release Capsules 30 mg nationwide due to N-nitroso-duloxetine impurity above recommended limits. Patients should contact their healthcare provider.
Product
Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0739-2025·2025-01-01
Blood Analysis System Software Error Can Assign Wrong Patient Name
Siemens epoc NXS Host blood analysis devices have a software malfunction that may assign the wrong patient name to blood test results, potentially leading to misdiagnosis or mistreatment.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; 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 ca
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-0725-2025·2025-01-01
Surgical Patties and Strips with Endotoxin Contamination in Medline Convenience Kits
Medline Industries is recalling surgical patties and strips in specific lots of KIT,SPINE LH Convenience Kits due to higher-than-expected endotoxin levels in raw materials. The contamination may result in out-of-specification endotoxin in finished sterile products.
Product
KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0756-2025·2025-01-01
Medline Surgical Needle Holders Recalled for Sterility Compromise
Medline is recalling 21,440 surgical needleholders due to weak seals that may compromise sterility and increase risk of contamination and infection during surgical use.
Product
ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0734-2025·2025-01-01
Blood Analysis System Recalled Due to Patient Name Assignment Software Error
Siemens is recalling the epoc NXS Host blood analysis system due to a software defect that can incorrectly assign patient names to test results, potentially causing misdiagnosis and mistreatment.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); 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 capill
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0733-2025·2025-01-01
Inflation Device for Cardiovascular Procedures Risk of Air Embolism from Potential Leak
Abbott Vascular inflation devices used in heart procedures may leak at connection points, potentially causing air embolism in patients.
Product
20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.
Category
Medical Device
Distribution
40 states
HighFDA (Drugs)·D-0162-2025·2025-01-01
Duloxetine antidepressant recall for chemical impurity above FDA limit
Breckenridge Pharmaceutical is recalling Duloxetine 60 mg delayed-release capsules due to N-nitroso-duloxetine impurity above FDA's interim limit. The recall affects 76,968 bottles distributed nationwide.
Product
DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0758-2025·2025-01-01
Medline Reprocessed Bruns Curette Surgical Instruments Recalled for Weak Sterile Seals
Medline is recalling 21,440 reprocessed Bruns curettes due to weak sterile seals that may fail without user detection. This increases the risk of contamination and infection.
Product
ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0164-2025·2025-01-01
Diagnostic drug kit recalled due to sterility concerns and vial integrity issues
Curium US is recalling Technetium TC 99m Sestamibi diagnostic kits (Lot 092-24006) due to improper vial crimps that could compromise sterility assurance. The recall affects approximately 5,160 vials distributed nationwide.
Product
TECHNETIUM TC 99M SESTAMIBI — TECHNETIUM TC 99M SESTAMIBI (TECHNETIUM TC 99M SESTAMIBI)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0757-2025·2025-01-01
Sterile Magill Forceps Recalled Due to Weak Seals and Contamination Risk
Medline has recalled Sterile Magill Forceps (Item No. 66790) due to weak seals that may compromise sterility. The defect affects approximately 21,440 units distributed nationwide.
Product
STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790
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-0744-2025·2025-01-01
TEMA Elbow System Prostheses Recalled for Mechanical Behavior Concern
Limacorporate is recalling TEMA Elbow System prostheses due to potential differences in mechanical behavior between implanted devices and surgical revision tools. Approximately 87 devices distributed in Florida and Texas are affected.
Product
TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0730-2025·2025-01-01
Abbott 20/30 Indeflator devices recalled for potential leak risk
Abbott Vascular is recalling 20/30 Indeflator devices used in cardiovascular procedures due to potential leaks that could cause air embolism.
Product
20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-0735-2025·2025-01-01
Blood analyzer system recalled for patient name assignment software error
Siemens recalled its epoc NXS Host blood analyzer due to a software malfunction that can assign incorrect patient names to test results, potentially leading to misdiagnosis or mistreatment.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); 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 (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-0740-2025·2025-01-01
Siemens Blood Analysis Device Recalled Over Patient Name Mix-up Software Defect
Siemens is recalling the epoc NXS blood analysis system due to a software flaw that can assign incorrect patient names to test results, risking misdiagnosis or mistreatment if the operator doesn't verify the patient name.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; 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
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 (Devices)·Z-0755-2025·2025-01-01
Medline Surgical Scissors Recalled for Sterility Seal Defect
Medline O.R. scissors may have weak seals that compromise sterility, increasing risk of contamination and infection. Approximately 21,440 units from lot 2023052490 have been recalled nationwide.
Product
O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0753-2025·2025-01-01
Merlin PCS 3650 Pacemaker Programmer Software Anomaly May Cause Loss of Pacing
A software anomaly in Abbott's Merlin PCS 3650 programmer may prevent proper finalization of leadless pacemakers, causing loss of pacing function. The issue occurs when specific actions combine with brief telemetry loss.
Product
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0718-2025·2025-01-01
Surgical patties and strips recalled due to endotoxin contamination
Medline Industries is recalling FESS-MB PACK-LF Convenience kits containing surgical patties and strips due to higher-than-expected endotoxin levels in raw materials, resulting in out-of-specification finished products.
Product
FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0754-2025·2025-01-01
Sterile Kelly Hemostat Recalled Due to Weak Seals
Medline's STERILE STRT KELLY HEMOSTAT (SK8039S) is being recalled due to weak seals that could compromise sterility, increasing the risk of contamination and infection. The recall affects 21,440 units distributed nationwide.
Product
STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695
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 (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
HighFDA (Drugs)·D-0158-2025·2025-01-01
Duloxetine Delayed-Release Capsules Recalled Nationwide for Excess N-Nitroso Impurity
Amerisource Health Services LLC is recalling Duloxetine Delayed-Release Capsules due to N-nitroso-duloxetine impurity above recommended limits. The affected product was distributed nationwide in 1,815 bottles with two specific lot numbers and expiration dates.
Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
Category
Drug
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 (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 (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 (Drugs)·D-0160-2025·2025-01-01
Chlorpromazine Hydrochloride tablets recalled for manufacturing impurity excess
Glenmark Pharmaceuticals is recalling Chlorpromazine Hydrochloride tablets due to manufacturing deviations that resulted in an impurity exceeding FDA limits. The affected lot (17230133, expiring 12/31/2024) was distributed nationwide.
Product
CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
Category
Drug
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 (Devices)·Z-0762-2025·2025-01-01
MISHA Knee System Implants recalled due to fracture risk
Moximed is recalling 115 MISHA Knee System Implants in multiple US states due to a supplier component defect that may cause the implant to fracture, potentially leading to pain, swelling, and stiffness.
Product
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0166-2025·2025-01-01
Hyaluronic Acid Supplements Recalled for Potential Undeclared Pharmaceutical Contaminants
MXBBB is recalling hyaluronic acid caplets after notification that product may contain undeclared diclofenac and omeprazole. No analytical confirmation of contamination has been found, but the firm is recalling out of precaution.
Product
UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323
Category
Drug
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-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-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-0728-2025·2025-01-01
O&M Halyard Procedure Masks Recalled for Unmet Bioburden Testing Requirements
O&M HALYARD is recalling O&M Halyard Procedure Masks (Product Code 47117) nationwide because they do not meet bioburden testing requirements printed on the packaging.
Product
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
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-0742-2025·2025-01-01
Galaxy System bronchoscope power supply defect may injure lung tissue
Noah Medical's Galaxy System bronchoscope has defective power supply semiconductors that may fail during procedures, potentially causing pneumothorax or lung tissue injury when the scope is manually removed.
Product
Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Category
Medical Device
Distribution
15 states
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-0726-2025·2025-01-01
Surgical procedure kits recalled for elevated endotoxin levels
Medline surgical kits containing sterile surgical patties and strips have been recalled due to higher-than-expected endotoxin levels in raw materials. The affected supplies may pose a risk during sterile surgical procedures.
Product
Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N; 2) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119U; 3) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119V; 4) CRANIOTOMY CDS, SKU CDS981753K; 5) LAMINECTOMY CDS-LF, SKU CDS981923X; 6)
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-0747-2025·2025-01-01
Medical Device Recall: BD FACSLyric Flow Cytometer Power Supply Failure Risk
BD is recalling power supply modules in FACSLyric flow cytometers that may fail to power on or remain powered. Failure could expose lab staff to fumes and cause patient specimen loss or delayed test results.
Product
FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 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 tan
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0161-2025·2025-01-01
Duloxetine 30mg Capsules Recalled Due to Nitrosamine Impurity
Breckenridge Pharmaceutical is recalling 163,883 bottles of Duloxetine 30mg capsules nationwide due to N-nitroso-duloxetine impurity above FDA-recommended limits.
Product
DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0165-2025·2025-01-01
Duloxetine delayed-release capsules recalled due to manufacturing impurity
Duloxetine delayed-release 60mg capsules are being recalled nationwide due to N-nitroso-duloxetine impurity above recommended interim limits. Two lot numbers are affected: J0786744-061724 (blister cards) and B3002625-060524 (bottles).
Product
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0315-2025·2025-01-01
Diced cucumber products recalled for potential Salmonella contamination
E-Z SPUDS is recalling approximately 23,340 pounds of diced cucumber products distributed in Illinois due to potential Salmonella contamination.
Product
Cucumber Diced Greek Cut (1/8"x1/8"x1"), 360# Drum with poly liner item C0376, 30# Box with poly liner item C0369. Cucumber Diced Regular Cut (1/8"x1/8"x1/4"), 300# Drum with poly liner item C0390, 30# Box with poly line C0383
Category
Food
Distribution
1 state
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-0736-2025·2025-01-01
Siemens epoc Blood Analysis System Recalled for Patient Identification Software Error
Siemens is recalling epoc NXS Host blood analysis systems due to a software malfunction that can assign incorrect patient names to test results, potentially leading to misdiagnosis and mistreatment if not verified by the user.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; 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-0751-2025·2025-01-01
Daytona Small Stature Locking Caps recalled for manufacturing defects
SeaSpine Orthopedics is recalling 92 Daytona Small Stature CoCr Locking Caps due to manufacturing defects that prevent proper component mating. The devices were distributed in seven U.S. states.
Product
Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0731-2025·2025-01-01
Abbott Vascular inflation device may leak during cardiovascular procedures
Abbott Vascular is recalling 20/30 Priority Pack Accessory Kit inflation devices due to potential leaks that could cause air embolism during cardiovascular procedures.
Product
20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).
Category
Medical Device
Distribution
40 states
ModerateFDA (Devices)·Z-0729-2025·2025-01-01
O&M Halyard Surgical Masks Recalled for Failing Bioburden Testing
O&M Halyard SOFT TOUCH II Surgical Masks (lot AM4119961) are being recalled for not meeting EN 14683 bioburden testing standards printed on the packaging. No illnesses or injuries have been reported.
Product
O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0769-2025·2025-01-01
Hip Reconstruction System Component Mislabeled for Size
Waldemar Link is recalling 3 units of the LINK MP Reconstruction System Neck Segment due to a labeling error indicating the wrong size (XXL instead of standard), though all other specifications on the labels are correct.
Product
LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadeq
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0750-2025·2025-01-01
BYTE Aligner System Recalled for Virtual-Only Approval Workflow Gaps
Straight Smile LLC is recalling BYTE Aligner systems due to a virtual-only clinical workflow that may not adequately screen patients with contraindications for aligner use. Approximately 5.3 million devices are affected.
Product
BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function o
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0761-2025·2025-01-01
EMPOWR 3D Knee Tibial Insert Recalled for Wrong Product in Package
Encore Medical is recalling 9 units of EMPOWR 3D Knee Tibial Insert (Lot 076T1273A) because packages may contain an acetabular system instead of the intended knee insert, potentially causing surgical delays.
Product
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Category
Medical Device
Distribution
Distributed nationwide

Looking for a different month? Back to 2025.