Sterility problems recalls (page 2)
732 recalls.
- Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIReported October 7, 2026 · Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct... - Clear Eyes Redness Relief recall (Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company)
DrugClass IIReported September 30, 2026 · Lack of Assurance of Sterility - Clear Eyes Redness Relief recall (Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company)
DrugClass IIReported September 30, 2026 · Lack of Assurance of Sterility - AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% recall (Sterling Pharmaceutical Services LLC)
DrugClass IIReported September 30, 2026 · Lack of Assurance of Sterility - Lubricant Eye Drops-Cameron Pharmaceuticals recall (Sterling Pharmaceutical Services LLC)
DrugClass IIReported September 30, 2026 · Lack of Assurance of Sterility - Major LubriFresh P.M. Nighttime Ointment recall (Sterling Pharmaceutical Services LLC)
DrugClass IIReported September 30, 2026 · Lack of Assurance of Sterility - TRP The Relief Products* Gentle Eyes Lubricant Eye Drops recall (Sterling Pharmaceutical Services LLC)
DrugClass IIReported September 30, 2026 · Lack of Assurance of Sterility - Reliable-1 Laboratories Lubricating Tears recall (Sterling Pharmaceutical Services LLC)
DrugClass IIReported September 30, 2026 · Lack of Assurance of Sterility - Walgreens Lubricant Eye Drops recall (Sterling Pharmaceutical Services LLC)
DrugClass IIReported September 30, 2026 · Lack of Assurance of Sterility - Walgreens Lubricant Eye Drops recall (Sterling Pharmaceutical Services LLC)
DrugClass IIReported September 30, 2026 · Lack of Assurance of Sterility - Reliable -1 Laboratories recall (Sterling Pharmaceutical Services LLC)
DrugClass IIReported September 30, 2026 · Lack of Assurance of Sterility - AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% recall (Sterling Pharmaceutical Services LLC)
DrugClass IIReported September 30, 2026 · Lack of Assurance of Sterility - Halyard IV START KIT NON-STERILE recall (AVID Medical, Inc.)
Medical deviceClass IIReported September 30, 2026 · Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator. - Halyard IV START KIT NON-STERILE recall (AVID Medical, Inc.)
Medical deviceClass IIReported September 30, 2026 · Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator. - Halyard IV START KIT NON-STERILE recall (AVID Medical, Inc.)
Medical deviceClass IReported September 30, 2026 · Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides. - Dopamine HCl Inj. recall (Pfizer)
DrugClass IIReported September 23, 2026 · Lack of Assurance of Sterility - Convenience kits CATARACT PACK DYNJ59881A recall (Medline Industries, LP)
Medical deviceClass IIReported September 23, 2026 · Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to... - Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A recall (Medline Industries, LP)
Medical deviceClass IIReported September 23, 2026 · Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to... - Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F recall (Medline Industries, LP)
Medical deviceClass IIReported September 23, 2026 · Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to... - Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A recall (Medline Industries, LP)
Medical deviceClass IIReported September 23, 2026 · Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to... - Blood Culture Collection Venipuncture Kit 20/Cs recall (Medical Action Industries, Inc. 306)
Medical deviceClass IIReported September 23, 2026 · Blood culture convenience kits contain a component subject to a drug recall that due to an an open or incomplete seal on the packaging of the applicator may... - Haylard UNIV IMAGING BIOPSY TRUCUSTOM recall (AVID Medical, Inc.)
Medical deviceClass IReported September 23, 2026 · Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical. - Haylard BASIC BIOPSY TRAY recall (AVID Medical, Inc.)
Medical deviceClass IReported September 23, 2026 · Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical. - Haylard CONTINUOUS NERVE BLOCK TRAY recall (AVID Medical, Inc.)
Medical deviceClass IReported September 23, 2026 · Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical. - Haylard 18G SINGLE SHOT EPI TRAY recall (AVID Medical, Inc.)
Medical deviceClass IReported September 23, 2026 · Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical. - MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System recall (Bayer Medical Care, Inc.)
Medical deviceClass IIReported September 23, 2026 · Some devices may not have been properly sterilized due to a manufacturing sterilization issue. - Percutaneous Insertion Kit recall (Maquet Cardiopulmonary Gmbh)
Medical deviceClass IIReported September 23, 2026 · The packaging may not consistently maintain sterile barrier integrity. - Percutaneous Insertion Kit recall (Maquet Cardiopulmonary Gmbh)
Medical deviceClass IIReported September 23, 2026 · The packaging may not consistently maintain sterile barrier integrity. - Percutaneous Insertion Kit recall (Maquet Cardiopulmonary Gmbh)
Medical deviceClass IIReported September 23, 2026 · The packaging may not consistently maintain sterile barrier integrity. - Medline Convenience Kit: OPEN HEART A PACK recall (Medline Industries, LP)
Medical deviceClass IIReported September 23, 2026 · The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be... - Medline Convenience Kits: 1) DYNDB3086D recall (Medline Industries, LP)
Medical deviceClass IReported September 23, 2026 · The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the... - Medline Convenience Kits: 1) DYNDH1193 recall (Medline Industries, LP)
Medical deviceClass IReported September 23, 2026 · The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the... - Medline Convenience Kits: 1) DYKM1000B recall (Medline Industries, LP)
Medical deviceClass IReported September 23, 2026 · The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the... - Medline Convenience Kits: 1) ACC010308A recall (Medline Industries, LP)
Medical deviceClass IReported September 23, 2026 · The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the... - Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA recall (Medline Industries, LP)
Medical deviceClass IReported September 23, 2026 · The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the... - Medline Convenience Kits: 1) OPEN HEART ADULT recall (Medline Industries, LP)
Medical deviceClass IReported September 23, 2026 · The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the... - Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET recall (Medline Industries, LP)
Medical deviceClass IReported September 23, 2026 · The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the... - Halyard IV START KIT NON-STERILE REF: KRIV26-02 recall (AVID Medical, Inc.)
Medical deviceClass IReported September 23, 2026 · Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides - 0.9% Sodium Chloride Injection recall (B BRAUN MEDICAL INC)
DrugClass IReported September 16, 2026 · Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene - Epinephrine Injection recall (American Regent, Inc.)
DrugClass IReported September 16, 2026 · Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and... - Halyard IV Start Kit Non-Sterile REF: KRIV26-02 recall (AVID Medical, Inc.)
Medical deviceClass IIReported September 16, 2026 · Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper... - Kit: Single Shot Epidural 20/Cs recall (Medical Action Industries, Inc. 306)
Medical deviceClass IReported September 16, 2026 · Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility. - Kit: Epidural/Pain TQC 20/Cs recall (Medical Action Industries, Inc. 306)
Medical deviceClass IReported September 16, 2026 · Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility. - Glutathione 200 mg/mL recall (OPTIMAL BALANCE PHARMACY)
DrugClass IReported September 9, 2026 · Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin. - 2% Chlorhexidine Gluconate* Cloth recall (Sage Products, LLC)
DrugClass IIReported September 9, 2026 · Cross Contamination with Other Products - Carton label: Mycophenolate Mofetil for injection recall (Mylan Pharmaceuticals Inc)
DrugClass IIReported September 9, 2026 · Failed Dissolution Specifications - Daptomycin recall (Baxter Healthcare Corporation)
DrugClass IIReported September 9, 2026 · CGMP Deviations - Vancomycin Injection recall (Baxter Healthcare Corporation)
DrugClass IIReported September 9, 2026 · CGMP Deviations - Vasopressin recall (Baxter Healthcare Corporation)
DrugClass IIReported September 9, 2026 · CGMP Deviations - Clindamycin Injection USP in 5% Dextrose recall (Baxter Healthcare Corporation)
DrugClass IIReported September 9, 2026 · CGMP Deviations - Clindamycin Injection USP in 5% Dextrose recall (Baxter Healthcare Corporation)
DrugClass IIReported September 9, 2026 · CGMP Deviations - Clindamycin Phosphate in 0.9% Sodium Chloride Injection recall (Baxter Healthcare Corporation)
DrugClass IIReported September 9, 2026 · CGMP Deviations - Clindamycin Injection USP in 5% Dextrose recall (Baxter Healthcare Corporation)
DrugClass IIReported September 9, 2026 · CGMP Deviations - Nexterone recall (Baxter Healthcare Corporation)
DrugClass IIReported September 9, 2026 · CGMP Deviations - Pantoprazole Sodium in 0.9% Sodium Chloride Injection recall (Baxter Healthcare Corporation)
DrugClass IIReported September 9, 2026 · CGMP Deviations - Vasopressin recall (Baxter Healthcare Corporation)
DrugClass IIReported September 9, 2026 · CGMP Deviations - Famotidine Injection in Sodium Chloride Injection recall (Baxter Healthcare Corporation)
DrugClass IIReported September 9, 2026 · CGMP Deviations - Clindamycin Injection USP in 5% Dextrose recall (Baxter Healthcare Corporation)
DrugClass IIReported September 9, 2026 · CGMP Deviations - Daptomycin recall (Baxter Healthcare Corporation)
DrugClass IIReported September 9, 2026 · CGMP Deviations - Vancomycin Injection recall (Baxter Healthcare Corporation)
DrugClass IIReported September 9, 2026 · CGMP Deviations - Medline Convenience Kits: 1) BLOOD DRAW KIT recall (Medline Industries, LP)
Medical deviceClass IIReported September 9, 2026 · The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in...