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
Maquet Cardiovascular, Llc
Maquet Getinge-BEQ-T 5211 LARGE ECC SET Material:701064560
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge- BEQ-TOP 27700 Quadrox iD Pack Material: 701054389R02
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge- BEQ-TOP 39202 NICU ECC PACK Material: 701067313R01
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BEQ-TOP 22600 ECC QUADROX ID 3 Material:701049440R01
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge- BO-T 2303 3/8" x 3/8" Adult Pack Material: 709000004R01
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge- BEQ-T 5211 ECC Large Children's Hospital Material: 701064560R01
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BEQ-TOP 50903 Custom ECC Pack-Pedriatric Material: 709000078
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BEQ-T 46500 PRIME PACK Material:701065823
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BO-T 46200 3/16" x 1/4" Neonate Pack Material: 701065620
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BEQ-T 30601 CMC ACCESSORY KIT Material: 701064701
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BEQ-T 57000 Rotaflow Pack Material: 709000424
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BEQ-TOP 5900 3/8 Quadrox iD Pack w/BB Material: 701050228
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BEQ-T 8068 1/4" WITH BRIDGE Material: 701066883
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BO-T 2303 Small Adult Cardiac Surgery Material:709000004
Cardiac Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BEQ-TOP 49103 ECC Pack 0 No Bladder Material: 709000058
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BEQ-TOP 4901 Material: 701050839
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-T 22706 SAMPLE MANIFOLD Material:701054912
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BEQ-TOP 38300 ADULT CPS QID Material: 701055862
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BEQ-TOP 8207 1/4" ECC PACK Material: 701068395
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BO-T 46201 Small Pediatric Cardiac Surge Material: 709000133
Cardiac Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BEQ-T 36507 Accessory Pk Mercy Material: 709000390
Medical Devices·0 affected·Apr 18, 2019
High RiskFDA
Iso-tex Diagnostics, Inc
Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diag...
Injectable Drugs·54 affected·Apr 15, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Chlorothiazide 100 mg, 3.57 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·60 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, C...
Drugs·1,357 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·5,678 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Magnesium Sulfate 2 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·6,746 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
CeFAZolin 3 gm 100 mg/mL, 30 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·475 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) Mannitol 20%-16.3 mL, Potassium Chloride 2 meq/mL-13 mL, Sod...
Injectable Drugs·110 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, ...
Drugs·1,135 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Lidocaine 1% - Sodium Bicarb 8.4% 10:1, 10 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bld...
Drugs·40 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Oxytocin 30 units in NS 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·3,690 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Heparin Pork 30,000 Units in NS 1000 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·87 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Sodium Bicarbonate 150 mEq in D5W 1000 mL bags, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·100 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E,...
Drugs·215 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Magnesium Sulfate 6 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·196 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Vancomycin 1250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·737 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, N...
Drugs·532 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Clindamycin 900 mg in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·1,233 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive,...
Drugs·705 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Magnesium Sulfate 4 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·3,007 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Alteplase 1 mg/mL 1 mL in 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·97 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·6,667 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Ch...
Drugs·1,310 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
CefTRIAXone 1 GM, 100 mg/mL, 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·15 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
NICARdipine 25 mg in NS 250 mL EXCEL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·1,783 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Norepinephrine 16 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·2,567 affected·Apr 12, 2019
High RiskFDA
Cmc Enterprise Pharmacy
Vancomycin 1500 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drugs·715 affected·Apr 12, 2019