Sterility problems recalls (page 7)
732 recalls.
- Octreotide Acetate for Injectable Suspension recall (Teva Pharmaceuticals USA, Inc)
DrugClass IIReported April 1, 2026 · Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract... - CUROSURF recall (Chiesi USA, Inc.)
DrugClass IIReported April 1, 2026 · Lack of Assurance of Sterility - Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name:... recall (AMO Puerto Rico Manufacturing, Inc.)
Medical deviceClass IIReported April 1, 2026 · Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as... - 16F Dual Valved Splittable Sheath Introducer recall (Merit Medical Systems, Inc.)
Medical deviceClass IReported April 1, 2026 · 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure... - Flexible Cryoprobe recall (Erbe USA Inc)
Medical deviceClass IReported April 1, 2026 · Probes may rupture/burst during activation - Webcol Alcohol Prep pad recall (Cardinal Health 200, LLC)
DrugClass IReported March 25, 2026 · Non-Sterility: microbial contamination identified as Paenibacillus phoenicis - Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recall (Apotex Corp.)
DrugClass IIReported March 25, 2026 · Lack of Assurance of Sterility - EndoVive Safety PEG Kit recall (Boston Scientific Corporation)
Medical deviceClass IIReported March 18, 2026 · Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of... - 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk... recall (Becton Dickinson & Company)
Medical deviceClass IIReported March 18, 2026 · During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes. - Tirzepatide Inj recall (New Life Pharma LLC)
DrugClass IIReported March 11, 2026 · Lack of Assurance of Sterility - Tirzepatide Inj recall (New Life Pharma LLC)
DrugClass IIReported March 11, 2026 · Lack of Assurance of Sterility - Semaglutide Inj. recall (New Life Pharma LLC)
DrugClass IIReported March 11, 2026 · Lack of Assurance of Sterility - Semaglutide Inj recall (New Life Pharma LLC)
DrugClass IIReported March 11, 2026 · Lack of Assurance of Sterility - Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported March 11, 2026 · Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the... - Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported March 11, 2026 · Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the... - Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported March 11, 2026 · Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the... - Valley Springs 100% Natural Bottled Water packaged in the following size plastic jug... recall (Valley Springs Artesian Gold, LLC)
FoodClass IIReported March 4, 2026 · Water was bottled under insanitary conditions. - BioGlo Fluorescein Sodium Ophthalmic Strips USP recall (Wizcure Pharmaa Private Limited)
DrugClass IIReported March 4, 2026 · Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. - Bio Glo Fluorescein Sodium Ophthalmic Strips USP recall (Wizcure Pharmaa Private Limited)
DrugClass IIReported March 4, 2026 · Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. - CHNaO Fluorescein Sodium Ophthalmic Strips recall (Wizcure Pharmaa Private Limited)
DrugClass IIReported March 4, 2026 · Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. - Vista Gonio Eye Lubricant recall (Wizcure Pharmaa Private Limited)
DrugClass IIReported March 4, 2026 · Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. - Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief... recall (Wizcure Pharmaa Private Limited)
DrugClass IIReported March 4, 2026 · Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. - Vista Gel Hypromellose USP 0.3% w/v recall (Wizcure Pharmaa Private Limited)
DrugClass IIReported March 4, 2026 · Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. - Vista Tears Polyethylene Glycol 400 0.4% w/v recall (Wizcure Pharmaa Private Limited)
DrugClass IIReported March 4, 2026 · Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. - Adbry recall (LEO PHARMA INC)
DrugClass IIReported March 4, 2026 · Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber. - Meijer STERILE saline wound wash recall (Medline Industries, LP)
Medical deviceClass IIReported March 4, 2026 · Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility... - Medline Convenience Kits: 1) NAIL KIT recall (Medline Industries, LP)
Medical deviceClass IIReported March 4, 2026 · Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility... - Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION recall (Medline Industries, LP)
Medical deviceClass IIReported March 4, 2026 · Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility... - Medline Convenience Kits: 1) NAIL KIT recall (Medline Industries, LP)
Medical deviceClass IIReported March 4, 2026 · Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility... - Medline Sterile Saline Wound Wash recall (Medline Industries, LP)
Medical deviceClass IIReported March 4, 2026 · Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility... - Medline Surgical Packs: 1) PACK recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Surgical Gowns: 1) GOWN recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Surgical Drapes: 1) SHEET recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) ARTHROSCOPY CDS recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) SPINAL CDS recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) HYSTEROSCOPY recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) C-SECTION PACK recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT UROLOGY SLING recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) ROBOTIC GYN CDS-1 recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) OB KIT recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) NEURO SHUNT- CODMAN recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) CHEST/BREAST-LF recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) LVAD DRIVELINE TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) ADMIT KIT recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) DRAPE PACK recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) PPE KIT recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) DRAPE PACK-CHOICE recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT GENERAL CLOSURE recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) BURN PACK recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) WMC I D PACK-LF recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) LVAD DRIVELINE TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT ACES INSERT PEG recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) LITHOTOMY PACK recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) DENTAL PACK recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) PICC LINE TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) OPEN HEART CDS recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) OR ARTERIOGRAM recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) ENDO KIT W/SYRINGE recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) SCC RF PAIN MGMT recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) ANCILLARY PACK-LF recall (Medline Industries, LP)
Medical deviceClass IIReported February 25, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth... recall (Bard Peripheral Vascular Inc)
Medical deviceClass IIReported February 25, 2026 · Due to damage to outer tray that can potentially compromise the sterile barrier - Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment recall (Integra LifeSciences Corp. (NeuroSciences))
Medical deviceClass IIReported February 25, 2026 · Potential packaging failures, which could lead to a breach in the sterile barrier. - MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: recall (Integra LifeSciences Corp. (NeuroSciences))
Medical deviceClass IIReported February 25, 2026 · Potential packaging failures, which could lead to a breach in the sterile barrier. - MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: recall (Integra LifeSciences Corp. (NeuroSciences))
Medical deviceClass IIReported February 25, 2026 · Potential packaging failures, which could lead to a breach in the sterile barrier. - vancomycin HCl recall (Fresenius Kabi Compounding, LLC)
DrugClass IIReported February 18, 2026 · Lack of Assurance of Sterility - vancomycin HCl recall (Fresenius Kabi Compounding, LLC)
DrugClass IIReported February 18, 2026 · Lack of Assurance of Sterility - thiamine HCl recall (Fresenius Kabi Compounding, LLC)
DrugClass IIReported February 18, 2026 · Lack of Assurance of Sterility - ketamine HCl recall (Fresenius Kabi Compounding, LLC)
DrugClass IIReported February 18, 2026 · Lack of Assurance of Sterility - acyclovir sodium recall (Fresenius Kabi Compounding, LLC)
DrugClass IIReported February 18, 2026 · Lack of Assurance of Sterility - Testosterone 100mg Anastrozole 4mg recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone 87.5mg recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone 200mg recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone 100mg recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone 75mg recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone 100mg recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - ESTRADIOL recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - ESTRADIOL recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - ESTRADIOL recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter