SI-BONE iFuse TORQ Implant System
The iFuse TORQ Implant System may not be sterile because its packaging seal integrity was not assured.
Medical device recalls
Medical device recalls from FDA, newest first.
2 recalls
Medtronic Grafton DBM and Grafton Plus DBM Bone Grafts
Grafton DBM and Grafton Plus DBM may cause infection if implanted.
1 recall
Stryker Sustainability Solutions Bard EP XT Decapolar Steerable Diagnostic EP Catheter
The diagnostic EP catheter may have a breached sterile barrier, which could lead to particulate embolization, infection, or thrombus.
2 recalls
Olympus M3 Gold Autoclavable Foroblique Telescope 30 and Lateral Telescope 70
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
2 products
Merit Medical Embosphere Microspheres
Embosphere syringes may have holes in packaging that could affect the sterile barrier and lead to infection.
3 recalls
Halyard Medical Trays
Haylard 18G Single Shot EPI Tray may have quality and sterility issues.
4 products
Medline Convenience Kits for Anesthesia, Minor Procedures, Myringotomy and Cataract Surgery
Convenience kits may have open seals in sterile pouch packaging, which can compromise sterility and lead to contamination or patient infection.
4 products
Medical Action Blood Culture Collection Kits
Blood culture collection kits contain an applicator with an open or incomplete seal that may compromise sterility and lead to infection.
2 recalls
Maquet Percutaneous Insertion Kits and Guidewires
The packaging may not consistently maintain sterile barrier integrity.
3 products
Medline Open Heart A Pack Convenience Kit
The Medline Convenience Kit contains a cannula that may have a sterile barrier breach, risking infection.
1 recall
Medical Action Industries Epidural Kits
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
2 products
1 recall
AVID Medical Halyard IV Start Kits
The Halyard IV Start Kit lacks sterility assurance due to wrinkles in the paper lidding that may breach the seal area.
1 recall
Medline Convenience Kits
Medline Convenience Kits contain applicators with a potential breach of sterility in the packaging.
16 products
1 recall
Halyard Medical Convenience Kits
Halyard medical convenience kits may contain neurological sponges with unexpected variability of endotoxin levels.
3 products1 recall
American Contract Systems Medical Procedure Kits and Trays
Medical procedure kits and trays may have unexpected variability of endotoxin levels on included sponges.
2 products1 recall
Arrowhead DE Arrow-LOK Implant
The Arrow-LOK Implant did not undergo required gamma radiation dose audit, which could lead to patient infection.
1 recall
BD Intravascular Administration and Extension Sets
Intravascular administration sets may not have received adequate sterilization processing.
1 recall
Spectra Medical Devices Sodium Chloride Injection
Sodium Chloride Injection, 0.9%, USP 10mL Ampule may have compromised sterility, exposing patients to microorganisms, endotoxins, or foreign matter.
1 recall
Covidien V-Loc, Dermalon and Surgipro Wound Closure Devices
V-Loc 90 Absorbable Wound Closure Device may have a perforation or tear in its sterile barrier packaging, which may lead to infection or prolonged surgery.
5 products
1 recall
Zimmer Biomet Intramedullary Bone Saw Blade Assembly
The Intramedullary Bone Saw Blade Assembly may have damaged sterile barrier packaging due to an exposed saw blade.
5 products
1 recall
Boston Scientific Radial Jaw 4 Biopsy Forceps
Radial Jaw 4 Standard Capacity Biopsy Forceps may have a breach in the sterile barrier of their packaging.
3 products
1 recall
AMS Aligned Medical Solutions Surgical Procedure Packs
Medical convenience kits contain neurological sponges with potentially variable endotoxin levels.
4 products
1 recall
Karl Storz Flexible Hystero-Fiberscope Kits
Flexible Hystero-Fiberscope Kits may contain an expired seal, impacting sterility assurance.
1 recall
Paragon 28 Phantom Hindfoot TTC/TC Ball Tipped Guide Rod
The P28 Phantom Intramedullary Nail System guide rod has breaches in its sterile barrier.
1 recall
Medline Kits Containing Zimmer Biomet Mixing Bowls and Spatulas
Medline kits with Zimmer Biomet mixing bowls and spatulas have seal nonconformities risking sterility breach.
2 products
2 recalls
Argon Medical Devices Cardiovascular and Biopsy Trays
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F may not meet sterility release criteria.
6 products
Olympus Evacuators
Some sterilization parameters may not consistently render the devices adequately sterile.
4 products
1 recall
OmniTract Surgical Retractor System
The OmniTract Surgical Retractor System has a dry time that needs to be extended.
1 recall
Boston Scientific Neuromodulation Intracept Access Instruments
Intracept Access Instruments may have a sterile barrier breach, which could lead to severe infection.
1 recall
Zimmer Biomet A.T.S. 4000 TS Tourniquet System Sterile Hoses
Sterile tourniquet hoses may have a sterility breach, potentially causing moderate localized infection.
2 products
1 recall
Boston Scientific CRE and CRE Pro Wireguided Balloon Dilators
Potential sterile breach of the pouches in which devices are packaged.
12 products
1 recall
Depuy Synthes Attune Revision Hinge Knee Components
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
2 products
1 recall
Arrow International Vascular Access and Catheterization Kits
Paracentesis kits contain lidocaine, bupivacaine.
35 products
2 recalls
Halyard Pain, Towel, Drape and Eye Bag Packs
Halyard, Pain Pack contains sealed pouches that had not undergone validated sterilization.
4 products
Boston Scientific Clik X Anchor
The Clik X Anchor may lack sterility assurance.
1 recall
Avanos Medical CORFLO and MIC Safety PEG Kits
Corflo and MIC Safety PEG Kits contain lidocaine hydrochloride injection that was recalled for quality issues.
20 products
1 recall
DeRoyal Covaderm Plus Vascular Access Dressings
Covaderm Plus, Vascular Access Dressing lacks sterility assurance.
1 recall
Covidien EndoStitch Polysorb Single Use Loading Unit
The Covidien EndoStitch Polysorb Single Use Loading Unit may have holes in its pouch, compromising the sterile barrier.
1 recall
Medtronic Gundry and DLP Retrograde Cannulas
Medtronic retrograde cannulas may have a sterile barrier breach.
9 products
1 recall
Stryker Sustainability Solutions Reprocessed Electrophysiology Catheters
Reprocessed electrophysiology catheters have incomplete seals on sterile product.
26 products
1 recall
Medline Convenience Kits, Surgical Drapes, Gowns and Packs
Medline Convenience Kits and Surgical Drapes may not be sterile due to calibration issues with sterilization equipment.
42 products
1 recall
Medline and Centurion Medical Convenience Kits
Medical convenience kits containing Webcol Large Alcohol Prep Pads may not be sterile due to a contaminant.
7 products
1 recall
Depuy Synthes Attune Revision Hinge Femoral
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
9 products
1 recall
Zimmer Disposable Mixing Bowls with Spatula
Disposable Mixing Bowls with Spatula may have incomplete or peeling seals, which could lead to infection.
1 recall
LSL Healthcare Central Line Dressing, Foley Urine Collection, IV Start and Wound Closure Kits
Medical procedure kits contain alcohol prep pads that may not be sterile.
6 products
1 recall
Medline CENTURION Circumcision Kit
The CENTURION Circumcision Kit was distributed without required sterilization and is not sterile.
1 recall
Medline Sterile Radiology Procedure Kits
Sterile Radiology Procedure Kits may have a breach in sterile packaging, compromising sterility.
1 recall
EndoVive Safety PEG Kit
The EndoVive Safety PEG Kit contains ChloraPrep Triple Swabsticks with open or compromised seals.
1 recall
Medline Sterile Saline Wound Wash and Convenience Kits
Medline Sterile Saline Wound Wash may not meet sterility requirements.
5 products
1 recall
Medline Convenience Kits and Surgical Drapes
Medline Convenience Kits and Surgical Drapes may not be sterile due to calibration issues in sterilization equipment.
42 products