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
Franck's Lab Inc Dba Trinity Care Solutions
Desferal 2.5 gm/14 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28314, Discard After 05/22/14
Drugs6 affectedMay 15, 2014
High RiskFDA
Franck's Lab Inc Dba Trinity Care Solutions
Levofloxacin 750 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #29184, D...
Drugs7 affectedMay 15, 2014
High RiskFDA
Franck's Lab Inc Dba Trinity Care Solutions
Cubicin 444 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29114, Di...
Drugs1 affectedMay 15, 2014
High RiskFDA
Franck's Lab Inc Dba Trinity Care Solutions
Nafcillin 12 gm/300 mL, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29162, Discard ...
Drugs5 affectedMay 15, 2014
High RiskFDA
Franck's Lab Inc Dba Trinity Care Solutions
Cubicin 700 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29083, Di...
Drugs7 affectedMay 15, 2014
High RiskFDA
Franck's Lab Inc Dba Trinity Care Solutions
Cefepime 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28288, Discar...
Drugs24 affectedMay 15, 2014
High RiskFDA
Franck's Lab Inc Dba Trinity Care Solutions
Cubicin 543 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29175, Di...
Drugs10 affectedMay 15, 2014
High RiskFDA
Franck's Lab Inc Dba Trinity Care Solutions
Desferal 2 gm/8 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 27767...
Drugs2 affectedMay 15, 2014
High RiskFDA
Franck's Lab Inc Dba Trinity Care Solutions
Unasyn (ampicillin/sulbactam) 1.5 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Us...
Drugs60 affectedMay 15, 2014
High RiskFDA
Franck's Lab Inc Dba Trinity Care Solutions
Invanz (ertapenem)1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # ...
Drugs12 affectedMay 15, 2014
High RiskFDA
Franck's Lab Inc Dba Trinity Care Solutions
Tobramycin 300 mg/7.5 mL Syringe (for Neb), Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, ...
Drugs14 affectedMay 15, 2014
High RiskFDA
Franck's Lab Inc Dba Trinity Care Solutions
Vancomycin 1.25 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29185...
Drugs14 affectedMay 15, 2014
High RiskFDA
Franck's Lab Inc Dba Trinity Care Solutions
Cefazolin 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28837, Di...
Drugs21 affectedMay 15, 2014
High RiskFDA
Franck's Lab Inc Dba Trinity Care Solutions
Vancomycin 1 gm/100 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29186, Di...
Drugs21 affectedMay 15, 2014
High RiskFDA
Franck's Lab Inc Dba Trinity Care Solutions
Cefepime 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28879, Dis...
Drugs11 affectedMay 15, 2014
High RiskFDA
Franck's Lab Inc Dba Trinity Care Solutions
Ceftriaxone 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29150, Dis...
Drugs5 affectedMay 15, 2014
High RiskFDA
Bacterin International, Inc.
Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 units per box: 19...
Respiratory Devices390 affectedMay 15, 2014
High RiskFDA
Coopersurgical, Inc.
Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
Surgical Devices1,180 affectedMay 13, 2014
High RiskFDA
John W Hollis Inc
Polidocanol 1% Solution for Injection, each mL contains Polidocanol (Laureth 9) 10 mg, also contains Sterile Water for Injection, Ethyl A...
Injectable Drugs100 affectedMay 12, 2014
High RiskFDA
John W Hollis Inc
Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 50 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, T...
Injectable Drugs300 affectedMay 12, 2014
High RiskFDA
John W Hollis Inc
Mannitol 5% Solution for injection, Mannitol 50 mg, also contains Sterile Water for Injection, Chlorobutanol USP, 50 mL, JOHN HOLLIS Phar...
Injectable Drugs2,250 affectedMay 12, 2014
High RiskFDA
John W Hollis Inc
Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 40 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue ...
Drugs45 affectedMay 12, 2014
High RiskFDA
John W Hollis Inc
Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 20 mcg, 10 mL, JOHN HOLLIS Pharmacist, Inc 110 20th Avenue N, Nashville, TN...
Drugs10 affectedMay 12, 2014
High RiskFDA
John W Hollis Inc
Levocarnitine Solution for injection, l-Carnitine 50 mg, Also Contains Sterile Water for Injection and Benzyl Alcohol pH adjusted with HC...
Injectable Drugs1,750 affectedMay 12, 2014
High RiskFDA
John W Hollis Inc
PYRIDOXINE HCL, Pyridoxine HCl 100mg, Also Contans: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 3...
Drugs30 affectedMay 12, 2014
High RiskFDA
John W Hollis Inc
Liver Derivative Complex for injection, each mL contains: Liver Derivative Complex 25.5mg, also contains: Water for Injection, Phenol 0.5...
Injectable Drugs1,560 affectedMay 12, 2014
High RiskFDA
John W Hollis Inc
Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 20 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue ...
Drugs365 affectedMay 12, 2014
High RiskFDA
John W Hollis Inc
Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue ...
Drugs40 affectedMay 12, 2014
High RiskFDA
John W Hollis Inc
LIPOTROPIC GOLD, Each mL contains: Levocarnitine 5 mg, Thiamine 50 mg, Riboflavin-5 phosphate 5mg, Niacinimide 50mg, Calcium Pantothenate...
Injectable Drugs80 affectedMay 12, 2014
High RiskFDA
John W Hollis Inc
Papaverine HCl 30 mg, Phentolamine Mesylate 0.5 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenu...
Drugs25 affectedMay 12, 2014
High RiskFDA
John W Hollis Inc
Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth 9) 50 mg, also contains Sterile Water for Injection, Ethyl A...
Injectable Drugs550 affectedMay 12, 2014
High RiskFDA
John W Hollis Inc
B-Complex/Adenosine Inj sol, Adenosine-5-Monophosphate 0.03g, Choline Chloride 0.01g, Cyanocobalamin 0.3mg, Inositol 0.05g, Methionine 0....
Drugs30 affectedMay 12, 2014
High RiskFDA
John W Hollis Inc
METHYLCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Methylcobalamin 1000 mcg, Also Contains: Benzyl Alcohol, Sodium Chloride, Wat...
Drugs60 affectedMay 12, 2014
High RiskFDA
John W Hollis Inc
Testosterone Cypionate for Injection, each mL contains Testosterone Cypionate 200 mg, also contains: Cotton Seed Oil, Benzyl Benzoate, B...
Injectable Drugs50 affectedMay 12, 2014
High RiskFDA
John W Hollis Inc
Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc 110 20th Avenue N, Nashville, TN 3720...
Drugs170 affectedMay 12, 2014
High RiskFDA
John W Hollis Inc
MIC PLUS B12, Adenosine, L-Carnitine, Contains: Methionine 15mg, Choline 100mg, Inositol 50mg, B 12, 0.200mg, Adenosine 20mg, L-Carniti...
Drugs210 affectedMay 12, 2014
High RiskFDA
John W Hollis Inc
CYANOCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Each mL contains: Cyanocobalamin 1000 mcg, , Also Contains: Benzyl Alcohol, S...
Drugs2,650 affectedMay 12, 2014
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is p...
Medical Implants22 affectedMay 1, 2014
High RiskFDA
Flawless Beauty Llc
Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories...
Injectable Drugs0 affectedApr 29, 2014
High RiskFDA
Baxter Healthcare Corp.
Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthca...
Injectable Drugs19,152 affectedApr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
Medical Devices26,674 affectedApr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
DRAPE 9732722 TUBE STERILE O-ARM 20PK
Medical Devices26,674 affectedApr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
TUMOR RES. PACK 9733553 AxiEM S.M.
Medical Devices26,674 affectedApr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
KIT, 9731427, THORACIC TACTILE PROBES
Medical Devices26,674 affectedApr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as ...
Medical Devices0 affectedApr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Bard¿ Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 Indicated for use in the reconstruction of soft tissue defici...
Medical Devices0 affectedApr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
ENT PRGM 9734636 ADD FUSION NAV AxiEM
Medical Devices26,674 affectedApr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
MOUSE 9732721 STERILE O-ARM 10PK
Medical Devices26,674 affectedApr 24, 2014