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
Shippert Medical Technologies
Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction.
Medical Devices·56 affected·Oct 20, 2017
High RiskFDA
Terumo Bct, Inc.
HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
Medical Devices·281 affected·Oct 20, 2017
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (200 mcg per 100 mL) in 0.9% Sodium Chloride single dose CADD C...
Drugs·20 affected·Oct 19, 2017
High RiskFDA
Sca Pharmaceuticals, Llc
oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0086-44
Drugs·450 affected·Oct 19, 2017
High RiskFDA
Sca Pharmaceuticals, Llc
fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only,...
Drugs·116 affected·Oct 19, 2017
High RiskFDA
Sca Pharmaceuticals, Llc
HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone 25 mg/25 mL) Rx ...
Drugs·128 affected·Oct 19, 2017
High RiskFDA
Sca Pharmaceuticals, Llc
morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphine Dose 100 mg per...
Drugs·60 affected·Oct 19, 2017
High RiskFDA
Sca Pharmaceuticals, Llc
SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholine 200 mg / 10 ml) Rx Only, SCA Pharmaceuticals 88...
Drugs·1,248 affected·Oct 19, 2017
High RiskFDA
Sca Pharmaceuticals, Llc
PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syringe (1,000 mcg / 10 ml Total Dose), Rx On...
Drugs·1,221 affected·Oct 19, 2017
High RiskFDA
Sca Pharmaceuticals, Llc
Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag contains 9.3 mEq Ca++ Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct...
Drugs·76 affected·Oct 19, 2017
High RiskFDA
Sca Pharmaceuticals, Llc
HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL (HYDROmorphone Total Dose 1000 mcg) Rx Only, SCA Pharm...
Drugs·60 affected·Oct 19, 2017
High RiskFDA
Sca Pharmaceuticals, Llc
ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct...
Drugs·487 affected·Oct 19, 2017
High RiskFDA
Deroyal Industries Inc
DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage Tray, REF 47-763.04 b) Inci...
Surgical Devices·5,946 affected·Oct 16, 2017
High RiskFDA
Medtronic Minimally Invasive Therapies Group
MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.
Surgical Devices·0 affected·Oct 14, 2017
High RiskFDA
Flavorx Inc.
FLAVORx Sweetening Enhancer , the product is packaged as follows: Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #3281712 / E...
Food·420 affected·Oct 13, 2017
High RiskFDA
Flavorx Inc.
FLAVORx Sweetening Enhancer , the product is packaged as follows: Vet Sweetening Enhancer AQ, 2oz Bottle, Lot #161269 / Exp. Date 12/2...
Food·2,068 affected·Oct 13, 2017
High RiskFDA
Flavorx Inc.
FLAVORx Sweetening Enhancer , the product is packaged as follows: "Sweetening Enhancer AQ, 4oz & 1oz Bottles, Lot #161269 / Exp. Date ...
Food·24,600 affected·Oct 13, 2017
High RiskFDA
Ecolab, Inc.
Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches are packaged 10 ...
Surgical Devices·5,958 affected·Oct 13, 2017
High RiskFDA
Zimmer Biomet, Inc.
TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel...
Medical Devices·0 affected·Oct 11, 2017
High RiskFDA
Banner Pharmacy Services, Llc
Hydromorphone HCl 10 mg (0.2mg/ml) 50 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St...
Drugs·1,658 affected·Oct 10, 2017
High RiskFDA
Banner Pharmacy Services, Llc
VANCOmycin 1.25 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, A...
Drugs·2,443 affected·Oct 10, 2017
High RiskFDA
Banner Pharmacy Services, Llc
Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag, 125 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St ...
Drugs·1,359 affected·Oct 10, 2017
High RiskFDA
Banner Pharmacy Services, Llc
Norepinephrine Bitartrate16 mg added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St C...
Drugs·481 affected·Oct 10, 2017
High RiskFDA
Banner Pharmacy Services, Llc
fentaNYL citrate 1000 mcg (10 mcg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit...
Drugs·9,030 affected·Oct 10, 2017
High RiskFDA
Banner Pharmacy Services, Llc
OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 9...
Drugs·24,306 affected·Oct 10, 2017
High RiskFDA
Banner Pharmacy Services, Llc
Norepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detro...
Drugs·3,550 affected·Oct 10, 2017
High RiskFDA
Banner Pharmacy Services, Llc
Magnesium sulfate 10 Gm added to Lactated Ringer's 250 mL bags, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler,...
Drugs·7,578 affected·Oct 10, 2017
High RiskFDA
Banner Pharmacy Services, Llc
ePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler,...
Drugs·972 affected·Oct 10, 2017
High RiskFDA
Banner Pharmacy Services, Llc
VANCOmycin 1.5 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, A...
Drugs·3,136 affected·Oct 10, 2017
High RiskFDA
Banner Pharmacy Services, Llc
Ropivacaine HCL (PF) 0.2% (2mg/mL) 100 mL Cassette Rx Only Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226 NDC 7...
Drugs·2,173 affected·Oct 10, 2017
High RiskFDA
Banner Pharmacy Services, Llc
Midazolam HCL 100 mg (1mg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chan...
Drugs·966 affected·Oct 10, 2017
High RiskFDA
Banner Pharmacy Services, Llc
fentanyl citrate (PF) 1100 mcg (20 mcg/mL) 55 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Det...
Drugs·0 affected·Oct 10, 2017
High RiskFDA
Banner Pharmacy Services, Llc
Succinylcholine 200 mg/10 mL Syringe, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025088801
Drugs·2,792 affected·Oct 10, 2017
High RiskFDA
Medline Industries Inc
MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12 Fr, REF DYNCSDS12, 1 Each, Sterile
Surgical Devices·120 affected·Oct 10, 2017
High RiskFDA
Boston Scientific Corporation
RESONATE X4 CRT-D, Model G447, Sterile.
Medical Devices·11 affected·Oct 4, 2017
High RiskFDA
Boston Scientific Corporation
RESONATE EL ICD VR, Model D432, Sterile.
Medical Devices·5 affected·Oct 4, 2017
High RiskFDA
Boston Scientific Corporation
MOMENTUM X4 CRT-D, Model G138, Sterile.
Medical Devices·4 affected·Oct 4, 2017
High RiskFDA
Boston Scientific Corporation
RESONATE EL ICD DR, Model D433, Sterile.
Medical Devices·12 affected·Oct 4, 2017
High RiskFDA
Boston Scientific Corporation
VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with he...
Cardiac Devices·4 affected·Oct 4, 2017
High RiskFDA
Arthrex, Inc.
iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, ...
Medical Devices·20 affected·Oct 3, 2017
High RiskFDA
Rxq Compounding Llc
methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10
Injectable Drugs·945 affected·Sep 25, 2017
High RiskFDA
Smiths Medical Asd Inc.
CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (exc...
Medical Devices·11,170,535 affected·Sep 25, 2017
High RiskFDA
Angiodynamics, Inc.
Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angi...
Surgical Devices·28 affected·Sep 22, 2017
High RiskFDA
Medline Industries Inc
Medline Suture Removal Tray. Sterile. Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Drugs·65,563 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline General Purpose Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
Drugs·700 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
Injectable Drugs·350 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Drugs·280 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
Drugs·1,133 affected·Sep 21, 2017