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
RecallFDA
Synapse Biomedical Inc
NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 2...
Surgical Devices·71 affected·May 31, 2022
High RiskFDA
Paragon 28, Inc.
HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
Medical Implants·9 affected·May 26, 2022
High RiskFDA
Us Specialty Formulations Llc
B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chlorobutanol 0.5%, ...
Drugs·1,992 affected·May 24, 2022
High RiskFDA
Us Specialty Formulations Llc
Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN:...
Injectable Drugs·781 affected·May 24, 2022
CriticalFDA
Akcea Therapeutics, Inc.
Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefilled syringes, each containing 284 mg...
Injectable Drugs·450 affected·May 23, 2022
High RiskFDA
Roi Cps Llc
regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
Medical Devices·180 affected·May 20, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe, 5 x 10 Pre-filled Syringes, 6 x...
Injectable Drugs·30,180 affected·May 18, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Epinephrine Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx On...
Injectable Drugs·134,415 affected·May 18, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton...
Injectable Drugs·57,810 affected·May 18, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, ...
Injectable Drugs·64,450 affected·May 18, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL), Preservative Free, 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 S...
Injectable Drugs·6,150 affected·May 18, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Hydromorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL), 30 mL Pre-Filled Syringe, 5 x 30 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, ...
Injectable Drugs·6,210 affected·May 18, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Ketamine Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton...
Injectable Drugs·107,530 affected·May 18, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Lidocaine HCl Injection, USP, 2%, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-FIlled Syringes, 6 x 5...
Injectable Drugs·65,590 affected·May 18, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL Pre-Filled Syringe, packaged in a) 10 x 1 syringe car...
Injectable Drugs·13,612 affected·May 18, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Ketamine Hydrochloride Injection, USP, 30 mg/3 mL (10 mg/mL), 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton...
Injectable Drugs·30,290 affected·May 18, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringe, 5 x 4 mL Pre-Filled Syringes, 6 x 5 Syrin...
Injectable Drugs·115,640 affected·May 18, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-filled Syringes, 6 x 5 Syringe Carton, Rx O...
Injectable Drugs·35,850 affected·May 18, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syri...
Injectable Drugs·604,080 affected·May 18, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL), 150 mL IV Bag, 10 x 1 IV Bag, Rx Only, Nephron 503B...
Injectable Drugs·3,532 affected·May 18, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP, 500 mL Single-Dose Container Bag, 10 x 1 IV Bag, Rx Only...
Injectable Drugs·3,587 affected·May 18, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carto...
Injectable Drugs·76,860 affected·May 18, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton,...
Injectable Drugs·585,660 affected·May 18, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Succinylcholine Chloride Injection, USP, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringe...
Injectable Drugs·181,560 affected·May 18, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syr...
Injectable Drugs·32,550 affected·May 18, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Hydromorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL), 50 mL Pre-Filled Syringe, 5 x 50 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, R...
Injectable Drugs·2,795 affected·May 18, 2022
High RiskFDA
Medical Modeling, Inc.
3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
Medical Devices·1 affected·May 17, 2022
High RiskFDA
Volcano Corp
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Medical Devices·11 affected·May 16, 2022
RecallFDA
Volcano Corp
Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Surgical Devices·14 affected·May 13, 2022
High RiskFDA
Earthlab Inc
Wise Woman Herbals Standardized Kava Glycerite, product is liquid and contains 15 mg Kavalactones (from Piper methysticum) and 9 mg Kaval...
Food·2 affected·May 11, 2022
High RiskFDA
Earthlab Inc
Wise Woman Herbals Sleepytime Glycerite. Product is liquid and strength is 20% presence in formula. Dosage: 60 drops 1-4 times a day. ...
Baby Food & Formula·1 affected·May 11, 2022
High RiskFDA
Earthlab Inc
Wise Woman Herbals Kava Capsules, 450 mg Kava (Piper met. Root), Dosage: 1 capsule up to 3 times per day day at 450mg Kava root. 90 coun...
Food·1,213 affected·May 11, 2022
High RiskFDA
A.p. Nonweiler
Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-Sterile Solution, Packaged as (a) 250 U.S. gallons per tote, Product Code 9...
Topical Drugs·833 affected·May 11, 2022
High RiskFDA
Olympia Compounding Pharmacy Dba Olympia Pharmacy
Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32...
Injectable Drugs·1,466 affected·May 9, 2022
High RiskFDA
Olympia Compounding Pharmacy Dba Olympia Pharmacy
Lidocaine 2% (20 mg/mL), Multi-Dose 30 mL vial , Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198...
Drugs·1,195 affected·May 9, 2022
High RiskFDA
Olympia Compounding Pharmacy Dba Olympia Pharmacy
T-106 Papaverine 30 mg/mL Phentolamine 1 mg/mL Alprostadil 25 mcg/mL, Packaged as a) 5 mL Multi-Dose vial NDC 73198-0013-05; b) 10 mL Mul...
Drugs·3,185 affected·May 9, 2022
High RiskFDA
Olympia Compounding Pharmacy Dba Olympia Pharmacy
Sodium Selenite 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 731...
Drugs·2,333 affected·May 9, 2022
High RiskFDA
Olympia Compounding Pharmacy Dba Olympia Pharmacy
QM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmace...
Drugs·914 affected·May 9, 2022
High RiskFDA
Olympia Compounding Pharmacy Dba Olympia Pharmacy
Pyridoxine HCL 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198...
Drugs·1,306 affected·May 9, 2022
High RiskFDA
Olympia Compounding Pharmacy Dba Olympia Pharmacy
Magnesium Chloride, 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC ...
Drugs·1,597 affected·May 9, 2022
High RiskFDA
Olympia Compounding Pharmacy Dba Olympia Pharmacy
NB-343 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 30 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd.,...
Drugs·606 affected·May 9, 2022
High RiskFDA
Olympia Compounding Pharmacy Dba Olympia Pharmacy
Bimix-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL, Packaged as a) 2.5 mL Multi-Dose Vial, NDC73198-0027-03; b) 10 mL Multi-Dose Vial, NDC ...
Drugs·1,287 affected·May 9, 2022
High RiskFDA
Olympia Compounding Pharmacy Dba Olympia Pharmacy
Sodium Tetradecyl Sulfate 0.3% Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL...
Injectable Drugs·943 affected·May 9, 2022
High RiskFDA
Olympia Compounding Pharmacy Dba Olympia Pharmacy
Diluent for Reconstitution Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 7319...
Drugs·42,722 affected·May 9, 2022
High RiskFDA
Olympia Compounding Pharmacy Dba Olympia Pharmacy
Phenylephrine 1 mg/mL, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-002...
Drugs·9,102 affected·May 9, 2022
High RiskFDA
Olympia Compounding Pharmacy Dba Olympia Pharmacy
Vitamin D3 (50,000 IU/mL)Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-...
Supplements·3,083 affected·May 9, 2022
High RiskFDA
Olympia Compounding Pharmacy Dba Olympia Pharmacy
Alpha Lipoic Acid 25 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 731...
Drugs·3,286 affected·May 9, 2022
High RiskFDA
Olympia Compounding Pharmacy Dba Olympia Pharmacy
Cyanocobalamin 2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0...
Drugs·1,282 affected·May 9, 2022