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
Pharmedium Services, Llc
ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, PharMEDium 913 N. Davis Ave....
Injectable Drugs·1,500 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis ...
Injectable Drugs·900 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject ...
Injectable Drugs·290 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMEDium Services, LLC 36 Stutte Road D...
Injectable Drugs·75 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium...
Injectable Drugs·1,840 affected·Mar 16, 2020
High RiskFDA
The Medicine Shoppe Pharmacy
Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tamiami Trail Port Charlotte, FL 33952
Drugs·4 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis ...
Injectable Drugs·1,350 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. D...
Injectable Drugs·1,075 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Fr...
Injectable Drugs·4,625 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMEDium Services LLC ...
Injectable Drugs·80 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, L...
Drugs·210 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Da...
Injectable Drugs·375 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Cleveland MS 36732. NDC 71019-3...
Injectable Drugs·2,250 affected·Mar 16, 2020
High RiskFDA
Medical Center Pharmacy, Inc.
C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 67457-0340-01.
Drugs·1 affected·Mar 13, 2020
High RiskFDA
Medical Center Pharmacy, Inc.
*Morphine 2 mg/mL Cassette, 100 mL CADD Cassette, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 00409-...
Drugs·1 affected·Mar 13, 2020
High RiskFDA
Medical Center Pharmacy, Inc.
C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 3731...
Drugs·2 affected·Mar 13, 2020
High RiskFDA
Medical Center Pharmacy, Inc.
*Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457...
Ophthalmic Drugs·2 affected·Mar 13, 2020
High RiskFDA
Biomet, Inc.
Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in sur...
Medical Devices·125 affected·Mar 13, 2020
High RiskFDA
Merit Medical Systems, Inc.
PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
Medical Devices·1,932 affected·Mar 11, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
Injectable Drugs·32,592 affected·Mar 5, 2020
High RiskFDA
Pfizer Inc.
Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. ...
Injectable Drugs·24,714 affected·Feb 27, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
Medical Devices·230 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
Medical Devices·230,001 affected·Feb 26, 2020
RecallFDA
Breckenridge Pharmaceutical, Inc
Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Ca...
Injectable Drugs·900 affected·Feb 24, 2020
High RiskFDA
Epimed International
R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Product Usage: The E...
Medical Devices·1,374 affected·Feb 21, 2020
High RiskFDA
Epimed International
R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI: 257-2010D(01)00818788022127 - Product Usage:The Ep...
Medical Devices·701 affected·Feb 21, 2020
High RiskFDA
Nextremity Solutions
Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correc...
Medical Implants·190 affected·Feb 12, 2020
High RiskFDA
Covidien Llc
Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East, and Africa) only. No US distri...
Surgical Devices·0 affected·Feb 10, 2020