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
Potassium Chloride in 5% Dextrose in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Methadone HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Labetalol HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Midazolam HCl in 5% Dextrose in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Fentanyl Citrate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Adenosine Injection in all strengths, all doses, and all packaging.
Injectable Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Potassium Chloride in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Rocuronium Bromide in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Morphine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Lidocaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Phenylephrine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
HYDROmorphone HCl in 5% Dextrose in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Vecuronium Bromide in Sterile Water for Injection in all strengths, all doses, and all packaging.
Injectable Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
HYDROmorphone HCl Injection in all strengths, all doses, and all packaging.
Injectable Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Atropine Sulfate Injection in all strengths, all doses, and all packaging.
Injectable Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Midazolam HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Ketamine HCl Injection in all strengths, all doses, and all packaging.
Injectable Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Esmolol HCl in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Neostigmine Methylsulfate Injection in all strengths, all doses, and all packaging.
Injectable Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Lidocaine HCl in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Dexamethasone Sodium Phosphate added to 5% Dextrose in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Meperidine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Methadone HCl Injection in all strengths, all doses, and all packaging.
Injectable Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Midazolam HCl Injection in all strengths, all doses, and all packaging.
Injectable Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Nicardipine HCl in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Ropivacaine HCl Injection in all strengths, all doses, and all packaging.
Injectable Drugs·0 affected·Dec 27, 2017
High RiskFDA
Arrow International Inc
(1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue Fl...
Surgical Devices·0 affected·Dec 22, 2017
High RiskFDA
Arrow International Inc
(1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-...
Medical Devices·0 affected·Dec 22, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-251...
Surgical Devices·0 affected·Dec 22, 2017
High RiskFDA
Arrow International Inc
(1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) ...
Surgical Devices·0 affected·Dec 22, 2017
High RiskFDA
Arrow International Inc
Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part Number: CDC-12123-P1A
Surgical Devices·0 affected·Dec 22, 2017
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 4923...
Drugs·3,734 affected·Dec 20, 2017
High RiskFDA
Ad-tech Medical Instrument Corporation
Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long a...
Medical Devices·30 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM STERILE ATN LAG SCREW 70MM STERILE ATN LAG SCREW 75MM STER...
Medical Devices·3,454 affected·Dec 20, 2017
RecallFDA
Livanova Usa
Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, ...
Medical Devices·16 affected·Dec 19, 2017
High RiskFDA
Deroyal Industries Inc
DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine...
Surgical Devices·226 affected·Dec 19, 2017
High RiskFDA
Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The Cardiovascular ...
Medical Devices·2,677 affected·Dec 18, 2017
High RiskFDA
Kalila Medical
Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile...
Medical Devices·99 affected·Dec 14, 2017
High RiskFDA
Kalila Medical
Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inserted into a shelf ...
Medical Devices·261 affected·Dec 14, 2017
High RiskFDA
Encore Medical, Lp
EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery.
Medical Devices·2 affected·Dec 12, 2017
High RiskFDA
Encore Medical, Lp
DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery.
Medical Devices·2 affected·Dec 12, 2017
High RiskFDA
Smith & Nephew, Inc.
smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STOUT STRAIGHT P...
Medical Devices·2 affected·Dec 11, 2017
High RiskFDA
Medical Action Industries Inc
Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) / product # AVID266 Sterile This OR towel produc...
Medical Devices·31,440 affected·Dec 11, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Medical Devices·22 affected·Dec 11, 2017