Open, ClassifiedPosted Dec 23, 2024·Initiated Nov 12, 2024
STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790
Reason: Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Root cause: Process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Forceps, General & Plastic SurgeryDistribution: US Nationwide distribution.Recall #Z-0757-2025
Open, ClassifiedPosted Dec 23, 2024·Initiated Nov 12, 2024
ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
Reason: Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Root cause: Process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: CuretteDistribution: US Nationwide distribution.Recall #Z-0758-2025
Open, ClassifiedPosted Dec 23, 2024·Initiated Nov 12, 2024
ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785
Reason: Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Root cause: Process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Hook, Surgical, General & Plastic SurgeryDistribution: US Nationwide distribution.Recall #Z-0759-2025
Open, ClassifiedPosted Dec 23, 2024·Initiated Nov 12, 2024
RUMMELL, Medline Item No. ST006ST
Reason: Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Root cause: Process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Tray, SurgicalDistribution: US Nationwide distribution.Recall #Z-0760-2025
Open, ClassifiedPosted Dec 23, 2024·Initiated Dec 10, 2024
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Reason: Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
Root cause: Labeling Change Control
Recalling firm: Encore Medical, LPType: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerDistribution: US Nationwide distribution in the states of IN, KS, CA, FL, NY, TX, AL, WA.Recall #Z-0761-2025
Open, ClassifiedPosted Dec 23, 2024·Initiated Dec 2, 2024
MISHA Knee System Implant Small, Left, REF: 2-1001.
MISHA Knee System Implant Small, Right, REF: 2-1002.
Reason: Knee implant may fracture due to a supplier-related issue with one component that has nonconforming geometry at the distal end of the absorber component that may result in a reduced wall thickness and microcracks, which may lead to new or worsening symptoms of discomfort, swelling / edema, pain or stiffness, which may necessitate removal of the device.
Root cause: Nonconforming Material/Component
Recalling firm: Moximed, Inc.Type: Medial Knee Implanted Shock AbsorberDistribution: US Nationwide distribution in the states of CA, OR, NY, OH, TX, CO, NY, VA.Recall #Z-0762-2025
Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 20, 2024
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
Reason: A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current glucose test result to the DMS. The risk of this software defect is erroneously high or low glucose results being documented in a patient's medical record, which may lead to incorrect treatment.
Root cause: Software design
Recalling firm: Nova Biomedical CorporationType: Prescription Use Blood Glucose Meter For Near-Patient TestingDistribution: Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.Recall #Z-0681-2025
Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 20, 2024
StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
Reason: A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current test result to the DMS.
Root cause: Software design
Recalling firm: Nova Biomedical CorporationDistribution: Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.Recall #Z-0682-2025
Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 20, 2024
StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing
Reason: A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current test result to the DMS.
Root cause: Software design
Recalling firm: Nova Biomedical CorporationDistribution: Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.Recall #Z-0683-2025
Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 8, 2024
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Reason: SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
Root cause: Unknown/Undetermined by firm
Recalling firm: Hologic, Inc.Type: Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial AgentsDistribution: US: AKRecall #Z-0694-2025 Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 15, 2024
mint Lesion, Software Versions: 3.9.0 through 3.9.5.
Reason: Some software versions have a malfunction
where they may show incorrect orientation labels for a specific subset of DICOM images.
Root cause: Software design
Recalling firm: Mint Medical GmbHType: System, Image Processing, RadiologicalDistribution: Worldwide distribution: US (nationwide): AR, CA, FL, GA, MI, MN, NY, OH, PA, TN, TX, WI; and OUS (International) to countries of: Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom.Recall #Z-0709-2025
Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 15, 2024
mint Lesion, Software Versions: 3.10.0 and 3.10.1.
Reason: Some software versions have a malfunction
where they may show incorrect orientation labels for a specific subset of DICOM images.
Root cause: Software design
Recalling firm: Mint Medical GmbHType: System, Image Processing, RadiologicalDistribution: Worldwide distribution: US (nationwide): AR, CA, FL, GA, MI, MN, NY, OH, PA, TN, TX, WI; and OUS (International) to countries of: Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom.Recall #Z-0710-2025
Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 6, 2024
MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures.
Reason: Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Root cause: Nonconforming Material/Component
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Cardiac Catheterization KitDistribution: US Nationwide. Canada.Recall #Z-0717-2025
Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 6, 2024
FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I.
Convenience kits used for various procedures..
Reason: Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Root cause: Nonconforming Material/Component
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Cardiovascular Procedure KitDistribution: US Nationwide. Canada.Recall #Z-0718-2025
Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 6, 2024
DIEP FLAP Convenience kit, SKU DYNJ910120.
Convenience kits used for various procedures.
Reason: Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Root cause: Nonconforming Material/Component
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Ct Biopsy TrayDistribution: US Nationwide. Canada.Recall #Z-0719-2025
Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 6, 2024
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) ENT HUTCH, SKU DYNJ58856A; 9) PACK NASAL, SKU DYNJ60111A; 10) PACK NASAL, SKU DYNJ60111B; 11) ENT CUSTOM PACK, SKU DYNJ63052C; 12) ENT PACK, SKU DYNJ64256D; 13) FESS/SEPTOPLASTY PACK, SKU DYNJ64509B; 14) SINUS ENDOSCOPY PACK, SKU DYNJ65644; 15) ACOUSTICS SHSC-LF, SKU DYNJ66749; 16) TRANSPHENOIDAL PACK, SKU DYNJ67423A; 17) TRANSPHENOIDAL PACK, SKU DYNJ67423B; 18) ENT PACK, SKU DYNJ68102B; 19) E N T PACK, SKU DYNJ80526B; 20) NASAL PACK, SKU DYNJ81280; 21) ENT FESS PACK, SKU DYNJ81420A; 22) HEAD AND NECK PACK, SKU DYNJ81934; 23) HEAD AND NECK PACK - 51597, SKU DYNJ81934A; 24) HEAD AND NECK ENT PACK, SKU DYNJ83679A; 25) HEAD NECK PACK HC, SKU DYNJ84270; 26) TRANSPHENOIDAL PACK-LF, SKU DYNJ85422; 27) NASAL SEPTAL, SKU DYNJ901299A; 28) NASAL SEPTAL, SKU DYNJ901299B; 29) PACK TRANSPHENOIDAL, SKU DYNJ905685D; 30) SEPTOPLASTY, SKU DYNJ906474C; 31) LEFORTE MANDIBLE, SKU DYNJ906839A; 32) NASAL MHS, SKU DYNJ908545A; 33) NASAL MHS, SKU DYNJ908545B; 34) ENT, SKU DYNJ909128A; 35) ENT, SKU DYNJ909128C; 36) ENT, SKU DYNJ909128D; 37) ENT, SKU DYNJ909128F; 38) SINUS PACK, SKU DYNJ909370
Reason: Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Root cause: Nonconforming Material/Component
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Ear, Nose, And Throat Surgical TrayDistribution: US Nationwide. Canada.Recall #Z-0720-2025
Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 6, 2024
Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF
, SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120A
Reason: Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Root cause: Nonconforming Material/Component
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Laparoscopy KitDistribution: US Nationwide. Canada.Recall #Z-0721-2025
Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 6, 2024
SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F.
Convenience kits used for various procedures.
Reason: Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Root cause: Nonconforming Material/Component
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Plastic Surgery And Accessories KitDistribution: US Nationwide. Canada.Recall #Z-0722-2025
Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 6, 2024
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; 6) LYMPHATIC BYPASS PACK, SKU
DYNJ69907A; 7) HEAD AND NECK PACK - 51597, SKU DYNJ81934B; 8) MAJOR CRANIOTOMY PACK, SKU DYNJ82007A; 9) SPINE PACK, SKU DYNJ82011A; 10) CRANIOTOMY MERCY STK 256, SKU DYNJ84068; 11) WMC UNIVERSAL NEURO PACK, SKU DYNJ84496A; 12) SPINE PACK LF, SKU DYNJ85830; 13) AHT SPINE PACK, SKU DYNJ903566D; 14) LAMINECTOMY SPINAL FUSION PACK, SKU DYNJ909364A; 15) DIEP, SKU DYNJ909472; 16) AMBULATORY SINUS, SKU DYNJ910292; 17) AMBULATORY SINUS, SKU DYNJ910292A
Reason: Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Root cause: Nonconforming Material/Component
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: General Surgery TrayDistribution: US Nationwide. Canada.Recall #Z-0723-2025
Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 6, 2024
Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T;
2) NEURO KIT, SKU CDS981327Q;
3) NEURO POSTERIOR SPINE PACK-LF, SKU DYNJ0311501I;
4) ACOUSTIC NEUROMA PACK-LF, SKU DYNJ37741D;
5) SCRIPPS SW NEURO PACK-LF, SKU DYNJ39836C;
6) SCRIPPS SW NEURO PACK-LF, SKU DYNJ39836D;
7) NEURO BUNDLE-LF, SKU DYNJ40095A;
8) NEURO BUNDLE-LF, SKU DYNJ40095B;
9) NEURO BUNDLE-LF, SKU DYNJ40095C;
10) NEURO BUNDLE-LF, SKU DYNJ40095D;
11) NEURO PACK-LF, SKU DYNJ42844D;
12) WMC VP SHUNT PACK-LF, SKU DYNJ50629J;
13) NEURO PACK, SKU DYNJ54255A;
14) NEURO CHRISTUS, SKU DYNJ61190A;
15) NEURO KIT, SKU DYNJ62854B;
16) NEURO KIT, SKU DYNJ62854C;
17) NEURO PACK NTX, SKU DYNJ66213D;
18) NEURO PACK, SKU DYNJ67628C;
19) BASIC NEURO CUSTOM, SKU DYNJ83387;
20) BASIC NEURO CUSTOM, SKU DYNJ83387A;
21) HALY NEURO PACK, SKU DYNJ87308;
22) FHWC NEURO, SKU DYNJ906131B;
23) CRANI, SKU DYNJ907865;
24) KIT NEURO LAFAYETTE, SKU DYNJ908615C;
25) GENERAL NEURO, SKU DYNJ909744
Reason: Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Root cause: Nonconforming Material/Component
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Neurological TrayDistribution: US Nationwide. Canada.Recall #Z-0724-2025