Hazard Type

Sterility Issue Recalls

10,814 product recalls involving sterility issue. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

10,814Total Recalls
297Critical
67933.1MUnits Affected
All Recalls

Every Sterility Issue Recall

Sorted by most recent. Click any recall for full details and safety information.

10,814 recalls
High RiskFDA
Maquet Medical Systems Usa
BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
Respiratory Devices·15,880 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRAPE PACK, Model Number 00-400305R...
Medical Implants·173,449 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA ...
Medical Devices·0 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 70000-USA 701067820 HMO 7...
Respiratory Devices·0 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETER INSERTION KIT CLABSI, Model Number C...
Surgical Devices·2,739 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB BASIN PACK, Model Number DYNJ69864A
Medical Devices·2,304 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number...
Surgical Devices·40 affected·May 18, 2023
High RiskFDA
Astral Steritech Private Ltd.
Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288...
Injectable Drugs·249,080 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-00...
Injectable Drugs·236,610 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Gr...
Injectable Drugs·7,940 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC ...
Injectable Drugs·223,590 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-006-30
Injectable Drugs·1,229,090 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin and Sulbactam for Injection, USP 3 grams vials, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-2...
Injectable Drugs·91,860 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-212-42
Injectable Drugs·65,950 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC66...
Injectable Drugs·112,640 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66...
Injectable Drugs·357,550 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70...
Injectable Drugs·964,420 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-223-41
Injectable Drugs·45,160 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Piperacillin and Tazobactam for Injection, USP 2.25 g per vial,s Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grov...
Injectable Drugs·169,520 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66...
Injectable Drugs·58,770 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo G...
Injectable Drugs·393,930 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 1...
Injectable Drugs·6,127 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ceftriaxone for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-213-42
Injectable Drugs·73,475 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin for Injection, USP 1g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594...
Injectable Drugs·80,850 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-577-10
Injectable Drugs·204,860 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Cefepime for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-209-41
Injectable Drugs·41,320 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Cefepime for Injection, USP 1 gram per vial, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-089-02
Injectable Drugs·550,160 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin for Injection, USP 2 g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 7059...
Injectable Drugs·220,340 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-058-10
Injectable Drugs·124,010 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 1...
Injectable Drugs·11,555 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-022-10
Injectable Drugs·419,680 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Cefepime for Injection, USP 2 grams per vial, Rx only, Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-009-20
Injectable Drugs·107,320 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 7...
Injectable Drugs·59,530 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-5...
Injectable Drugs·1,288,510 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin for Injection, USP 10 g per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 6679...
Injectable Drugs·8,925 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 6679...
Injectable Drugs·1,001,110 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Piperacillin and Tazobactam for Injection, UPS, 3.375 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo...
Injectable Drugs·936,680 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-220-41
Injectable Drugs·70,040 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin and Sulbactam for Injection, USP 1.5 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-021-10
Injectable Drugs·59,040 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 606...
Injectable Drugs·35,087 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-211-42
Injectable Drugs·66,250 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin for Injection, USP 1g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-222-41
Injectable Drugs·89,690 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin for Injection, USP, 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC ...
Injectable Drugs·53,220 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove...
Injectable Drugs·119,340 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC...
Injectable Drugs·66,175 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Gro...
Injectable Drugs·7,214 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66...
Injectable Drugs·138,610 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ceftriaxone for Injection, USP, 1 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, ND...
Injectable Drugs·739,750 affected·May 15, 2023