Medical Device Recalls

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8,689 medical device recalls from federal enforcement feeds.

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Showing 5,151–5,200 of 8,689

Medical Device Recall · November 14, 2024
Kirwan Surgical Products, LLC
Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. Fo
Potential for the outer stainless-steel tube to break or detach.
Class I
Medical Device Recall · November 14, 2024
Kirwan Surgical Products, LLC
Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and ot
Potential for the outer stainless-steel tube to break or detach.
Class I
Medical Device Recall · November 14, 2024
Kirwan Surgical Products, LLC
Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and
Potential for the outer stainless-steel tube to break or detach.
Class I
Medical Device Recall · November 14, 2024
Kirwan Surgical Products, LLC
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other s
Potential for the outer stainless-steel tube to break or detach.
Class I
Medical Device Recall · November 13, 2024
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer Error that is displayed on the navigation bar in the User Interface. The analyzer enters the red system status and will generate a SYS flag. The tests that are in progress may be cancelled and may cause a delay in reporting patient results
Class II
Medical Device Recall · November 13, 2024
Alcon Research LLC
Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D delivery cartridge Lens Guide, Intraocular Component: N/A
Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (IOL) upon delivery.
Class II
Medical Device Recall · November 12, 2024
MEDLINE INDUSTRIES, LP - Northfield
O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000
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.
Class II
Medical Device Recall · November 12, 2024
Aerin Medical, Inc.
Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
Some units in a single production lot were programmed incorrectly which will result in the VivAer Stylus being incorrectly recognized as RhinAer Stylus when connected to the Aerin Console.
Class II
Medical Device Recall · November 12, 2024
MEDLINE INDUSTRIES, LP - Northfield
ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
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.
Class II
Medical Device Recall · November 12, 2024
MEDLINE INDUSTRIES, LP - Northfield
RUMMELL, Medline Item No. ST006ST
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.
Class II
Medical Device Recall · November 12, 2024
MEDLINE INDUSTRIES, LP - Northfield
STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695
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.
Class II
Medical Device Recall · November 12, 2024
MEDLINE INDUSTRIES, LP - Northfield
STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790
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.
Class II
Medical Device Recall · November 12, 2024
Siemens Healthcare Diagnostics, Inc.
Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista¿ Total Magnesium (MG) Flex Reagent Cartridges (lots 24057BB and 24064BC) due to the potential for falsely low measurements of magnesium in plasma. Because the error is intermittent, existing quality control procedures may not recognize that a patients results are incorrect, and the results may be reported out
Class II
Medical Device Recall · November 12, 2024
MEDLINE INDUSTRIES, LP - Northfield
ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785
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.
Class II
Medical Device Recall · November 12, 2024
MEDLINE INDUSTRIES, LP - Northfield
ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870
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.
Class II
Medical Device Recall · November 11, 2024
Gauthier Biomedical, Inc.
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
An out of specification component may result in the device exhibiting torque output higher than the design specification.
Class II
Medical Device Recall · November 11, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number:
Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed as for systems over 10 years of life with LTE kits are experiencing propeller motor clamping bolt and x-ray tube locking bolt breaks. If this happens, it may cause erratic C-arm movements and potential collision with patients or bystanders, or detection of a false collisions and subsequent blocked movement of the c-arm. Movement may also cause image noise and black area on the x-ray image, and possible need to expose the patient to additional unnecessary radiation during re-examination.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFB; 3) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFC
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ) KIT, NASAL , Catalog Number: PE23NSMEA; 2 ) KIT, NASAL , Catalog Number: PE23NSMEC; 3 ) KIT,SEPTOPLASTY NEW HAN
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG5 3) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Numb
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHHA:; 3 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERM5:;
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLZ; 3) KIT,NEURO SPINE,ANDERSON , Catalog N
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II
Medical Device Recall · November 8, 2024
O&M HALYARD, INC.
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB 3) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFC
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110D 3) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952; 3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910; 4) KIT,ORP PLAS
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMD9; 3) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76L
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM3; 3 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM5; 4 ) ANEURYSM PACK ,
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVB 3) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP , Catalog Nu
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH1; 3) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH2; 4) KIT,H
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II
Medical Device Recall · November 8, 2024
O&M HALYARD, INC.
O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.
Class II
Medical Device Recall · November 8, 2024
Hologic, Inc.
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC42; 3) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC43;
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI S
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog N
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH2 ; 2 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH3 ; 3 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH4 ; 4 ) LARY
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II
Medical Device Recall · November 8, 2024
Beckman Coulter Inc.
Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and
The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a prolonged period before performing the intact PTH (parathyroid hormone) test may produce falsely decreased intact parathyroid hormone results. This could lead to a missed diagnosis, a delay in treatment, or inappropriate clinical management, depending upon the patient s clinical condition.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog Number: SENHDDPVCH; 3 ) ORP DENTAL PACK, Catalog Number: SENHDDPVCI
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5 3 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH6 4 ) KIT, FETAL
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II
Medical Device Recall · November 7, 2024
Diasorin Inc.
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's internal investigation determined that 0.14% of the LIAISON Q.S.E.T. Device Plus in the lots identified have loose clear caps, which may allow buffer to leak from the tube. A stool sample prepared with less than the correct amount of buffer may result an incorrectly high patient result.
Class II
Medical Device Recall · November 6, 2024
MEDLINE INDUSTRIES, LP - Northfield
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
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
Class II
Medical Device Recall · November 6, 2024
MEDLINE INDUSTRIES, LP - Northfield
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
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
Class II
Medical Device Recall · November 6, 2024
MEDLINE INDUSTRIES, LP - Northfield
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 DYNJ6160
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
Class II
Medical Device Recall · November 6, 2024
ICU Medical, Inc.
ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolock is needle free and cannot be deactivated, which
Due to finished goods incorrectly packaged and labeled.
Class II
Medical Device Recall · November 6, 2024
MEDLINE INDUSTRIES, LP - Northfield
DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.
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
Class II
Medical Device Recall · November 6, 2024
MEDLINE INDUSTRIES, LP - Northfield
KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
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
Class II