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
Astral Steritech Private Ltd.
Ceftriaxone for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-214-42
Injectable Drugs·41,500 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LL...
Injectable Drugs·23,187 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC ...
Injectable Drugs·66,125 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Cefepime for Injection, USP 1 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-057-10
Injectable Drugs·101,550 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ceftriaxone for Injection, USP, 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, ND...
Injectable Drugs·243,825 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-221-41
Injectable Drugs·17,350 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-215-15
Injectable Drugs·9,040 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, ...
Injectable Drugs·591,160 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Cefepime for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-210-41
Injectable Drugs·51,280 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 712...
Injectable Drugs·893,950 affected·May 15, 2023
High RiskFDA
Astral Steritech Private Ltd.
Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 712...
Injectable Drugs·110,660 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FISTULA, Model Numb...
Surgical Devices·146,157 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PROBE COVER PACK, Mod...
Medical Devices·154,900 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PEDIATRIC CATH ANGIO PA...
Cardiac Devices·233,638 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. SHY IR PICC PACK, Mod...
Medical Devices·148,445 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. C V MINOR PACK, Model...
Medical Devices·371 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAPHY PACK, Mod...
Medical Implants·15,323 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CRMC MINOR IR PROCEDURE...
Cardiac Devices·76,870 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR MOTT DRAPE PACK, M...
Medical Devices·36 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CHN OR DAVINCI PROSTA...
Medical Devices·7,462 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CAROTID, Model Number...
Medical Devices·3,431 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. AAA PACK, Model Number:...
Cardiac Devices·46,124 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. FETAL INTERVENTION, M...
Medical Devices·9,319 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIALYSIS ACCESSORY PA...
Surgical Devices·135 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. OPEN HEART CDS-LF, Mode...
Cardiac Devices·43,149 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ART LINE KIT ICH OR, M...
Surgical Devices·4,900 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PACK ENDO AAA HYBRID ...
Medical Devices·80 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model Number: DYNJ45158A
Medical Devices·192 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC PACK, Model Numbe...
Medical Devices·6,733 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: ...
Medical Devices·15,945 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION PACK, Model ...
Surgical Devices·16,143 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. VASCULAR PACK, Model ...
Medical Implants·100,549 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model ...
Medical Devices·1,231,480 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (13) STC IVC FILTER/ANG...
Cardiac Devices·97,677 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB PACK, Model ...
Medical Devices·624 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAM TRAY, Model...
Medical Devices·29,126 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000
Medical Devices·189,221 affected·May 12, 2023
High RiskFDA
Revive Rx Llc Dba Revive Rx Pharmacy
Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx, 3831 Golf Dr A, ...
Drugs·45 affected·May 11, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
Medical Devices·851,328 affected·May 3, 2023
High RiskFDA
Apollo Care, Llc
FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3...
Injectable Drugs·308 affected·May 2, 2023
High RiskFDA
Apollo Care, Llc
Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65...
Injectable Drugs·2,040 affected·May 2, 2023
High RiskFDA
Apollo Care, Llc
VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65...
Injectable Drugs·646 affected·May 2, 2023
High RiskFDA
Apollo Care, Llc
Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. ...
Injectable Drugs·682 affected·May 2, 2023
High RiskFDA
Apollo Care, Llc
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 6...
Injectable Drugs·1,113 affected·May 2, 2023
High RiskFDA
Apollo Care, Llc
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 6...
Injectable Drugs·1,113 affected·May 2, 2023
High RiskFDA
Apollo Care, Llc
VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 6...
Injectable Drugs·491 affected·May 2, 2023
High RiskFDA
Apollo Care, Llc
VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65...
Injectable Drugs·2,040 affected·May 2, 2023
High RiskFDA
Apollo Care, Llc
VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 652...
Injectable Drugs·1,622 affected·May 2, 2023