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
Central Admixture Pharmacy Services, Inc.
oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, P...
Injectable Drugs·1,996 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Ave...
Injectable Drugs·298 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, A...
Drugs·4,100 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC ...
Drugs·3,519 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, EVA Bag, Rx only, Ce...
Drugs·84 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
PHENYLephrine, added to 0.9% sodium chloride, 40mg/250ml (160mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 So...
Injectable Drugs·292 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbona...
Drugs·786 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Serv...
Drugs·304 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Centr...
Injectable Drugs·140 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag, Rx only, Central Admixture Pharmacy Ser...
Drugs·84 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenu...
Injectable Drugs·703 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, total volume = 1047 mL, EVA Bag, Rx only, Central Admixture Phar...
Drugs·100 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South ...
Injectable Drugs·292 affected·Aug 17, 2023
High RiskFDA
Central Admixture Pharmacy Services, Inc.
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Centra...
Injectable Drugs·104 affected·Aug 17, 2023
High RiskFDA
Cardinal Health 200, Llc
Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.
Medical Devices·13,351 affected·Aug 16, 2023
High RiskFDA
Cardinal Health 200, Llc
Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.
Medical Devices·13,351 affected·Aug 16, 2023
High RiskFDA
Cardinal Health 200, Llc
Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catal...
Medical Devices·13,351 affected·Aug 16, 2023
High RiskFDA
Cardinal Health 200, Llc
Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN Anterior Hip, Steril...
Medical Devices·13,351 affected·Aug 16, 2023
High RiskFDA
Tmc Acquisitions Llc Dba Tailor Made Compounding
Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.
Drugs·9 affected·Aug 15, 2023
High RiskFDA
Tmc Acquisitions Llc Dba Tailor Made Compounding
NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding.
Drugs·99 affected·Aug 15, 2023
RecallFDA
Caplin Steriles Limited
Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single vial), Rx only, D...
Injectable Drugs·19 affected·Aug 14, 2023
High RiskFDA
Baxter Healthcare Corporation
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healt...
Drugs·22,112 affected·Aug 11, 2023
High RiskFDA
Baxter Healthcare Corporation
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Co...
Drugs·44,520 affected·Aug 11, 2023
RecallFDA
Imprimis Njof, Llc
Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewoo...
Ophthalmic Drugs·2,683 affected·Aug 10, 2023
High RiskFDA
B. Braun Medical, Inc.
B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid...
Medical Devices·604,800 affected·Aug 7, 2023
High RiskFDA
B. Braun Medical, Inc.
B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/f...
Medical Devices·534,000 affected·Aug 7, 2023
High RiskFDA
Encore Medical, Lp
DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
Surgical Devices·20 affected·Aug 4, 2023
CriticalFDA
Medline Industries, Lp - Northfield
HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
Medical Devices·18,000 affected·Aug 4, 2023
High RiskFDA
Encore Medical, Lp
DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
Surgical Devices·10 affected·Aug 4, 2023
High RiskFDA
Encore Medical, Lp
DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030
Medical Implants·0 affected·Aug 4, 2023
High RiskFDA
Encore Medical, Lp
DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 3...
Surgical Devices·64 affected·Aug 4, 2023
High RiskFDA
Ansell Healthcare Products Llc
NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
Surgical Devices·378 affected·Aug 3, 2023
High RiskFDA
Syncardia Systems Llc
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Medical Devices·114 affected·Aug 1, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
Medical Devices·55 affected·Jul 31, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-steril...
Medical Devices·12 affected·Jul 20, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 ...
Drugs·2,077 affected·Jul 17, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
morphine in 0.9% sodium chloride, 125 mg/25 mL, (5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbro...
Drugs·723 affected·Jul 17, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunb...
Drugs·1,044 affected·Jul 17, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
midazolam in dextrose 5%, 50 mg /50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road,...
Drugs·621 affected·Jul 17, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
fentaNYL, 1250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, Sa...
Drugs·5,124 affected·Jul 17, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
fentaNYL, 5000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San ...
Drugs·94 affected·Jul 17, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
HYDROmorphone added to 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 100 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 79...
Drugs·3,824 affected·Jul 17, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA ...
Drugs·848 affected·Jul 17, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
PHENYLephrine in 0.9 sodium chloride, 800 mcg /10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San D...
Drugs·10,494 affected·Jul 17, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 7128...
Drugs·12,239 affected·Jul 17, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
morphine in 0.9% sodium chloride, 1 mg/1 mL, (1 mg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook R...
Drugs·1,699 affected·Jul 17, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbro...
Drugs·6,770 affected·Jul 17, 2023
High RiskFDA
Central Admixture Pharmacy Services Inc
morphine in 0.9% Sodium Chloride, 50 mg/50 mL (1mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook ...
Drugs·1,235 affected·Jul 17, 2023