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
Pine Pharmaceuticals, Llc
Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10 mL prefilled syri...
Injectable Drugs·920 affected·Jul 27, 2022
High RiskFDA
Wright Medical Technology, Inc.
Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.
Medical Implants·17 affected·Jul 27, 2022
High RiskFDA
Sterrx, Llc
fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY ...
Injectable Drugs·360 affected·Jul 25, 2022
High RiskFDA
Sterrx, Llc
FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903...
Injectable Drugs·720 affected·Jul 25, 2022
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700
Surgical Devices·825 affected·Jul 25, 2022
High RiskFDA
Baxter Healthcare Corporation
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673100
Medical Devices·24,320 affected·Jul 22, 2022
High RiskFDA
Baxter Healthcare Corporation
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack, REF H93869025, b) 100 pack, REF H938674100, c) 100 pack, RE...
Medical Devices·168,390 affected·Jul 22, 2022
High RiskFDA
Baxter Healthcare Corporation
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack, REF H93867025, b) 100 pack, REF H93867100
Medical Devices·63,190 affected·Jul 22, 2022
High RiskFDA
Baxter Healthcare Corporation
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Purple, 100 pack, REF H938677100
Medical Devices·8,500 affected·Jul 22, 2022
High RiskFDA
Medline Industries Inc.
Medline CHEST TUBE REORDER NO: DYNJ36762A
Medical Devices·300 affected·Jul 21, 2022
High RiskFDA
Cook Incorporated
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For vascular cathe...
Surgical Devices·865 affected·Jul 19, 2022
High RiskFDA
Cook Incorporated
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascular catheter posit...
Surgical Devices·1,450 affected·Jul 19, 2022
High RiskFDA
Cook Incorporated
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter posit...
Surgical Devices·1,997 affected·Jul 19, 2022
High RiskFDA
Cook Incorporated
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular cathe...
Surgical Devices·15 affected·Jul 19, 2022
High RiskFDA
Cook Incorporated
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular cath...
Surgical Devices·30 affected·Jul 19, 2022
High RiskFDA
Cook Incorporated
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For vascular cathete...
Surgical Devices·85 affected·Jul 19, 2022
High RiskFDA
Cook Incorporated
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular catheter positi...
Surgical Devices·496 affected·Jul 19, 2022
High RiskFDA
Cook Incorporated
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For vascular catheter...
Surgical Devices·585 affected·Jul 19, 2022
High RiskFDA
Aire-master Of America Inc
Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734
Drugs·4 affected·Jul 15, 2022
High RiskFDA
Aire-master Of America Inc
Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tamp...
Drugs·960 affected·Jul 15, 2022
High RiskFDA
Aire-master Of America Inc
Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606
Drugs·5,064 affected·Jul 15, 2022
High RiskFDA
Aire-master Of America Inc
Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa...
Drugs·9,176 affected·Jul 15, 2022
High RiskFDA
Aire-master Of America Inc
Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance F...
Drugs·18 affected·Jul 15, 2022
High RiskFDA
Aire-master Of America Inc
Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct...
Drugs·4,632 affected·Jul 15, 2022
High RiskFDA
Aesculap Implant Systems Llc
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic a...
Medical Implants·6 affected·Jul 15, 2022
CriticalFDA
Intera Oncology, Inc.
INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
Medical Implants·50 affected·Jul 10, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syr...
Injectable Drugs·18,840 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Injection, 50 mL syri...
Injectable Drugs·2,210 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Bupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL), Ketamine HCl 60 mg (1.2 mg/mL) Injection, 50 mL syringes, p...
Injectable Drugs·2,315 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged in 1 x 50 mL Pre-Filled Syringe per carton, 30 ...
Injectable Drugs·36,354 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Morphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carto...
Injectable Drugs·8,985 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Ketamine HCl Injection, USP, 50 mg/5 mL (10 mg/mL*) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton p...
Injectable Drugs·91,445 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carto...
Injectable Drugs·3,450 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
HYDROmorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) syringes, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per cas...
Injectable Drugs·12,900 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Neostigmine Methylsulfate Injection, USP, 4 mg/4 mL (1 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe...
Injectable Drugs·10,700 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL*) bags, packaged as 10 x 1 IV bag per case, Rx Only, ...
Injectable Drugs·9,410 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe C...
Injectable Drugs·75,630 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing facility, 4500 12th Extension, West Columbia, SC 291...
Injectable Drugs·163 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Morphine Sulfate Injection, USP, 1 mg/mL syringe, packaged in 5 x 1 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx ...
Injectable Drugs·4,620 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per...
Injectable Drugs·184,370 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Ca...
Injectable Drugs·464,265 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton pe...
Injectable Drugs·6,340 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Ketamine HCl Injection, USP 30 mg/3 mL (10 mg/mL*) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton pe...
Injectable Drugs·30,745 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe...
Injectable Drugs·64,365 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x 2 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton p...
Injectable Drugs·43,385 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, ...
Injectable Drugs·18,570 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carto...
Injectable Drugs·13,340 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Morphine Sulfate Injection, USP, 50 mg/50 mL (1 mg/mL) syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carto...
Injectable Drugs·5,495 affected·Jun 30, 2022