Boston Scientific CRE and CRE Pro Wireguided Balloon Dilators
Potential sterile breach of the pouches in which devices are packaged.
12 products
Sterility failure recalls
Recalls flagged for sterility failure, newest first. 106 recalls
1 recall
3 recalls
CareFusion 213 BD ChloraPrep and PurPrep Applicators
BD ChloraPrep and PurPrep applicators may be unsterile or contaminated with fungus, potentially causing serious infection or death.
10 products
Accord BioPharma Imuldosa Injection
Imuldosa injection lacks assurance of sterility.
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
PReye Vitamin See Antioxidant Preservative Free Eye Drops
PReye Vitamin See Antioxidant Preservative Free Eye Drops lack assurance of sterility.
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
Zep Alcohol Sanitizer Spray
Reason given by FDA: Microbial contamination of sterile products.
1 recall
BD ChloraPrep Clear Applicators
BD ChloraPrep Clear Applicators were recalled for lack of assurance of sterility or non-sterility.
4 products
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
Spectra Medical Devices Lidocaine HCl Injection
Lidocaine HCl Injection USP may lack sterility.
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.
2 recalls
UCB Cimzia Prefilled Syringes
Cimzia (certolizumab pegol) prefilled syringes lack assurance of sterility.
Medtronic Gundry and DLP Retrograde Cannulas
Medtronic retrograde cannulas may have a sterile barrier breach.
9 products
1 recall
Dechra Ophthavet Ophthalmic Solution for Dogs and Cats
Ophthavet Ophthalmic Solution has a potential quality concern at the manufacturing site.
1 recall
Stryker Sustainability Solutions Reprocessed Electrophysiology Catheters
Reprocessed electrophysiology catheters have incomplete seals on sterile product.
26 products
1 recall
Oasis Tears PF Preservative-Free Lubricant Eye Drops
Oasis Tears PF lubricant eye drops lack assurance of sterility.
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
2 recalls
Teva Octreotide Acetate for Injectable Suspension
Octreotide Acetate for Injectable Suspension lacks assurance of sterility due to quality system deficiencies.
BD PurPrep Povidone-Iodine and Isopropyl Alcohol Antiseptic Solution
BD PurPrep sterile solution may lack assurance of sterility due to potential contamination.
2 products
2 recalls
Fresenius Medical Care Delflex Peritoneal Dialysis Solution
Delflex, Dextrose Peritoneal Dialysis Solution may have leaks from perforations in bags, lacking assurance of sterility.
2 products
Harrow Eye FreshKote Lubricant Eye Drops
Freshkote Lubricant Eyedrops lack assurance of sterility.
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
2 recalls
Optase Dry Eye Intense Drops (Glycerin 0.2%)
Optase Dry Eye Intense Drops lack assurance of sterility.
iVIZIA Sterile Lubricant Eye Drops
IVIZIA Sterile Lubricant Eye Drops lack assurance of sterility due to manufacturing deviations.
2 products
2 recalls
GenTeal Tears and Systane Lubricant Eye Gel
Systane Lubricant Eye Gel Night Gel may lack assurance of sterility.
2 products
Zimmer Disposable Mixing Bowls with Spatula
Disposable Mixing Bowls with Spatula may have incomplete or peeling seals, which could lead to infection.
2 recalls
B. Braun Sterile Water, Dextrose, Sodium Chloride and Lactated Ringer's Injections and Irrigation
Sterile Water for Injection USP lacks assurance of sterility, which could cause leakage from the diaphragm port.
4 products
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.
2 recalls
International Medication Systems Epinephrine Injection
Epinephrine Injection lacks assurance of sterility.
Huons Lidocaine, Bupivacaine and Sodium Chloride Injections
Lidocaine HCl injection lacks assurance of sterility.
6 products
1 recall
Northwest Compounders Semaglutide-Glycine-Cyanocobalamin Injectable
Semaglutide-Glycine-Cyanocobalamin Injectable lacks assurance of sterility.
2 recalls
Fagron Norepinephrine and Vancomycin Injections
Norepinephrine Bitartrate and Vancomycin injections lack assurance of sterility, and a blue part could detach from the port.
5 products
Preferred Pharmaceuticals Artificial Tears Lubricant Eye Drops
Artificial Tears Lubricant Eye Drops lack assurance of sterility.
2 recalls
Fresenius Kabi Sodium Chloride and Dextrose Injections
Sodium chloride and dextrose injections lack assurance of sterility.
14 products
Cipla Lanreotide Injection
Lanreotide Injection lacks assurance of sterility due to deficiencies in visual inspection.
2 products
1 recall
2 recalls
Chiesi Curosurf Intratracheal Suspension
Curosurf (poractant alfa) lacks assurance of sterility.
Medline Sterile Radiology Procedure Kits
Sterile Radiology Procedure Kits may have a breach in sterile packaging, compromising sterility.
1 recall
Teva Octreotide Acetate for Injectable Suspension
Octreotide Acetate for Injectable Suspension lacks assurance of sterility due to quality system deficiencies.
6 products1 recall
Norbrook Noromycin 300 LA Oxytetracycline Injection
Noromycin 300 LA antibiotic lacks assurance of sterility.
2 recalls
Apotex Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution lacks assurance of sterility.
Cardinal Health Webcol Alcohol Prep Pads
Webcol Alcohol Prep pads may be non-sterile due to microbial contamination, posing an infection risk to vulnerable groups.
3 products
1 recall
EndoVive Safety PEG Kit
The EndoVive Safety PEG Kit contains ChloraPrep Triple Swabsticks with open or compromised seals.
1 recall
Nomida Semaglutide and Tirzepatide Injections
Semaglutide and tirzepatide injections lack assurance of sterility.
4 products
1 recall
Adbry (Tralokinumab-Ldrm) Injection
Adbry injection may not be sterile due to wool fiber particulate matter in one unit.
