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
Pharmacy Plus, Inc. Dba Vital Care Compounder
Moxifloxacin 0.5% + Dexamethazone 0.1%, 15ml vial Contains: Moxifloxacin 5mg/ml, Dexamethasone Sodium Phosphate 1mg/ml, Rx only, For oph...
Ophthalmic Drugs·1 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5 mL in a 10 mL MDV, Rx only, Vital Care Compounder, Hattiesb...
Drugs·386,606 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Olopatadine 0.8% Ophthalmic Solution, 3ml bottle, Rx, Vital Care Compounder, Hattiesburg, MS
Ophthalmic Drugs·0 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Moxifloxacin HCl 1 mg/ml (0.1mg/0.1ml) and BSS solution, 2ml Single use vial, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Drugs·16 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Morphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS
Injectable Drugs·1 affected·Jul 26, 2016
High RiskFDA
Howmedica Osteonics Corp.
AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion wit...
Medical Devices·0 affected·Jul 26, 2016
High RiskFDA
Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This product is inte...
Medical Devices·2,207 affected·Jul 25, 2016
High RiskFDA
Talon Compounding Pharmacy
Human Chorionic Gonadotropin Injection (a) 2500 iu, (b) 2500 iu with B12, (c) 3500 iu, (d) 5000 iu, (e) 5000 iu with B12, (f) 6000 iu, (g...
Injectable Drugs·6,500 affected·Jul 19, 2016
High RiskFDA
Talon Compounding Pharmacy
Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy...
Injectable Drugs·500 affected·Jul 19, 2016
High RiskFDA
Medtronic Sofamor Danek Usa Inc
TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
Medical Devices·1 affected·Jul 18, 2016
High RiskFDA
Medtronic Sofamor Danek Usa Inc
TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .
Medical Devices·3 affected·Jul 18, 2016
High RiskFDA
Medtronic Sofamor Danek Usa Inc
RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500, QTY: 1, STERILE R,
Medical Devices·0 affected·Jul 18, 2016
High RiskFDA
Medtronic Sofamor Danek Usa Inc
RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF 90-SRK-311400, QTY: 1, STERILE R,
Medical Devices·3 affected·Jul 18, 2016
High RiskFDA
Medtronic Sofamor Danek Usa Inc
TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
Medical Devices·2 affected·Jul 18, 2016
High RiskFDA
C.r. Bard, Inc.
Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
Surgical Devices·274 affected·Jul 11, 2016
High RiskFDA
C.r. Bard, Inc.
Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
Surgical Devices·274 affected·Jul 11, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code: E25303 The Valleylab Laparoscopic Handset and Electrodes ar...
Surgical Devices·19,200 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277236 The Valleylab Laparoscopic Handset and Electrodes are indicated f...
Surgical Devices·85,630 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Wire J-Hook Electrode 45CM Item Code: E277345 The Valleylab Laparoscopic Handset and Electrodes are indicated f...
Surgical Devices·24,870 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Flat L-Hook Electrode 28cm Item Code: E278428 The Valleylab Laparoscopic Handset and Electrodes are indicated f...
Surgical Devices·332 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Wire J-Hook Electrode 28CM Item Code: E278228 The Valleylab Laparoscopic Handset and Electrodes are indicated f...
Surgical Devices·0 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code: E2784R28ASP The Valleylab Laparoscopic Handset and Electrodes are...
Surgical Devices·3,470 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R36ASP The Valleylab Laparoscopic Handset and Electrodes are ...
Surgical Devices·50,055 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R28ASP The Valleylab Laparoscopic Handset and Electrodes are i...
Surgical Devices·63,320 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Item Code: E253028 The Valleylab Laparoscopic Handset and Electrodes are ...
Surgical Devices·13,420 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Curved Spatula Electrode 45CM Item Code: E277145 The Valleylab Laparoscopic Handset and Electrodes are indicated...
Surgical Devices·6,381 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Curved Spatula Electrode 36CM Item Code: E277136 The Valleylab Laparoscopic Handset and Electrodes are indicated...
Surgical Devices·161,940 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277336 The Valleylab Laparoscopic Handset and Electrodes are indicated fo...
Surgical Devices·349,629 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM Item Code: E2782R28ASP The Valleylab Laparoscopic Handset and Electrodes ...
Surgical Devices·1,440 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Curved Spatula Electrode 28CM Item Code: E278128 The Valleylab Laparoscopic Handset and Electrodes are indicate...
Surgical Devices·0 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Curved Spatula Electrode Retractable 28CM Item Code: E2781R28ASP The Valleylab Laparoscopic Handset and Electro...
Surgical Devices·0 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Wire L-Hook Electrode 28CM Item Code: E278328 The Valleylab Laparoscopic Handset and Electrodes are indicated fo...
Surgical Devices·42,900 affected·Jul 8, 2016
High RiskFDA
Medicap Pharmacy
Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID 83642, NDC 99999-9996-94.
Drugs·1 affected·Jul 7, 2016
High RiskFDA
Smith & Nephew, Inc.
SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated...
Medical Devices·185 affected·Jul 6, 2016
RecallFDA
Circulatory Technology Inc
The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide co...
Medical Devices·958 affected·Jul 1, 2016
High RiskFDA
Zimmer Biomet Spine, Inc
Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
Medical Devices·5 affected·Jun 30, 2016
High RiskFDA
Isomeric Pharmacy Solution, Llc
Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile. Rx only. Compounded by Isomeric Pharmac...
Injectable Drugs·274 affected·Jun 29, 2016
High RiskFDA
Vital Care Compounder, Llc
TESTOSTERONE CYPIONATE 200mg/ml, 1ML MDV, Vital Care Compounder, Hattiesburg, MS
Drugs·13 affected·Jun 29, 2016
High RiskFDA
Medtronic Xomed, Inc.
NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
Medical Devices·3,752 affected·Jun 28, 2016
High RiskFDA
Conmed Corporation
CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8190 The CORE Trumpe...
Medical Devices·0 affected·Jun 27, 2016
High RiskFDA
Conmed Corporation
CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Catalog Number CD8300 The CORE Trumpet (CD81XX, CD83XX, and C...
Medical Devices·0 affected·Jun 27, 2016
High RiskFDA
Conmed Corporation
CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags, Catalog Number CD8185 The CORE Trumpet (CD81XX...
Medical Devices·0 affected·Jun 27, 2016
High RiskFDA
Conmed Corporation
CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological lapa...
Medical Devices·0 affected·Jun 27, 2016
High RiskFDA
Conmed Corporation
CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags, Catalog Number CD8302 The CORE Trumpet (CD81XX, CD83X...
Medical Devices·0 affected·Jun 27, 2016
High RiskFDA
Danville Materials, Inc.
Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile component used with the Perioscopy System, wh...
Medical Devices·2,123 affected·Jun 24, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the s...
Medical Implants·47 affected·Jun 23, 2016
High RiskFDA
Draeger Medical, Inc.
Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non ste...
Medical Devices·1,599 affected·Jun 22, 2016
CriticalFDA
Microport Orthopedics Inc.
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA41, SIZE 4+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE ...
Medical Devices·77 affected·Jun 21, 2016