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
Rij Pharmaceutical Llc
Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz. (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1...
Supplements·8,124 affected·May 7, 2018
High RiskFDA
Rij Pharmaceutical Llc
RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, RIJ PHARMACEUTICAL CORPORATION, 40 COMMERCIAL AVENUE, MID...
Drugs·228 affected·May 7, 2018
High RiskFDA
Rij Pharmaceutical Llc
Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxide 200mg Simethicone 20mg, packaged in 12 FL. OZ. (355 mL) bo...
Drugs·0 affected·May 7, 2018
High RiskFDA
Rij Pharmaceutical Llc
GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 1120...
Drugs·21,213 affected·May 7, 2018
High RiskFDA
Rij Pharmaceutical Llc
Ritussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, Guaifenesin, USP 100mg), packaged in 4 FL.OZ. (118 mL), RIJ ...
Drugs·9,240 affected·May 7, 2018
High RiskFDA
Rij Pharmaceutical Llc
SDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, Distributed by SDA Laboratories 280 Railroad Avenue, Greenwic...
Drugs·3,537 affected·May 7, 2018
High RiskFDA
Rij Pharmaceutical Llc
Gericare Diocto Liquid (Docusate Sodium 50mg), 50 mg/5 mL, packaged in 16 FL OZ (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp....
Drugs·12,756 affected·May 7, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
Medical Devices·1,752 affected·May 7, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
Medical Devices·372 affected·May 7, 2018
High RiskFDA
Ethicon, Inc.
PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
Medical Devices·144 affected·May 7, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
Medical Devices·1,020 affected·May 7, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
Medical Devices·432 affected·May 7, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
Medical Devices·456 affected·May 7, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
Medical Devices·276 affected·May 7, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
Medical Devices·15,180 affected·May 7, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
Medical Devices·4,452 affected·May 7, 2018
High RiskFDA
Galt Medical Corporation
1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Cath...
Surgical Devices·13,210 affected·May 2, 2018
High RiskFDA
Galt Medical Corporation
Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,
Surgical Devices·300 affected·May 2, 2018
High RiskFDA
Galt Medical Corporation
Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-...
Medical Devices·23,777 affected·May 2, 2018
High RiskFDA
Galt Medical Corporation
Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055
Medical Devices·10,950 affected·May 2, 2018
High RiskFDA
Stryker Neurovascular
AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made ...
Medical Devices·15 affected·May 2, 2018
High RiskFDA
Galt Medical Corporation
1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Perip...
Medical Devices·8,350 affected·May 2, 2018
High RiskFDA
Galt Medical Corporation
1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-...
Medical Devices·3,160 affected·May 2, 2018
CriticalFDA
Auromedics Pharma Llc
Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics P...
Injectable Drugs·54,720 affected·May 1, 2018
High RiskFDA
Coast Quality Pharmacy Llc
Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium A...
Drugs·52 affected·Apr 26, 2018
High RiskFDA
Conseal International, Inc.
Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net. Wt. 4 fl. oz./118mL, Catalog No. NSP-04 The p...
Medical Devices·384 affected·Apr 25, 2018
High RiskFDA
Vitalab Pharmacy, Inc
Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc
Injectable Drugs·178 affected·Apr 24, 2018
High RiskFDA
Vitalab Pharmacy, Inc
Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/m...
Injectable Drugs·0 affected·Apr 24, 2018
High RiskFDA
Vitalab Pharmacy, Inc
Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile injectable, Vitalab Pharmacy, Inc
Injectable Drugs·3 affected·Apr 24, 2018
High RiskFDA
Vitalab Pharmacy, Inc
Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable, Vitalab Pharmacy, Inc
Injectable Drugs·22 affected·Apr 24, 2018
High RiskFDA
Vitalab Pharmacy, Inc
Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 10mcg/mL, Papaverine 30mg/Phent...
Injectable Drugs·60 affected·Apr 24, 2018
High RiskFDA
Vitalab Pharmacy, Inc
Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc
Injectable Drugs·2 affected·Apr 24, 2018
High RiskFDA
Torax Medical, Inc.
LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LX-xx, sterile, Rx only. Labeled as: a. Product Code LX-...
Medical Implants·9,131 affected·Apr 20, 2018
High RiskFDA
Torax Medical, Inc.
LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only. Labeled as: a. Product Code LX...
Medical Implants·9,131 affected·Apr 20, 2018
High RiskFDA
Torax Medical, Inc.
LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code LS-xx, sterile, Rx only. Labeled as: a. Product Code LS...
Medical Implants·9,131 affected·Apr 20, 2018
High RiskFDA
Microaire Surgical Instruments, Llc
MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAir...
Medical Devices·2,009 affected·Apr 19, 2018
High RiskFDA
St Jude Medical Inc.
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-4...
Medical Devices·40,738 affected·Apr 16, 2018
High RiskFDA
Trimed Inc.
Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation ...
Surgical Devices·722 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-...
Medical Devices·81,338 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, ...
Medical Devices·131,093 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 10...
Medical Devices·22,132 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/1000431...
Medical Devices·68,117 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001,...
Medical Devices·37,485 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 10011620...
Medical Devices·139,351 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-3...
Medical Devices·71,651 affected·Apr 16, 2018
High RiskFDA
Trimed Inc.
Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e)...
Medical Devices·706 affected·Apr 13, 2018
High RiskFDA
Trimed Inc.
Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
Medical Devices·323 affected·Apr 13, 2018
High RiskFDA
St Jude Medical, Cardiac Rhythm Management Division
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name o...
Cardiac Devices·2,906 affected·Apr 13, 2018