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
Nxstage Medical, Inc.
NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal ...
Medical Devices·21,071 affected·Oct 17, 2018
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. NxStage PureFlow B Solution is indicated for use with ren...
Medical Devices·59,100 affected·Oct 17, 2018
High RiskFDA
Richard Wolf Gmbh
Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscope...
Medical Implants·873 affected·Oct 17, 2018
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with re...
Medical Devices·15,880 affected·Oct 17, 2018
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal ...
Medical Devices·186,476 affected·Oct 17, 2018
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with re...
Medical Devices·7,275 affected·Oct 17, 2018
High RiskFDA
Argon Medical Devices, Inc
(1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxe...
Medical Devices·49,130 affected·Oct 16, 2018
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF 041230001A, 25/box, Sterile, Rx. The firm name o...
Medical Devices·49,130 affected·Oct 16, 2018
High RiskFDA
Argon Medical Devices, Inc
(1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Steri...
Medical Devices·49,130 affected·Oct 16, 2018
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The firm name on the label is Argon Medical Devices, In...
Medical Devices·49,130 affected·Oct 16, 2018
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Medical Devices·49,130 affected·Oct 16, 2018
High RiskFDA
Aso, Llc
Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x...
Medical Devices·218 affected·Oct 16, 2018
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which...
Medical Devices·49,130 affected·Oct 16, 2018
High RiskFDA
Heritage Pharmaceuticals, Inc.
Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India, M...
Injectable Drugs·2,789 affected·Oct 15, 2018
High RiskFDA
Icu Medical Inc
0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL ...
Injectable Drugs·2,580,448 affected·Oct 8, 2018
High RiskFDA
Icu Medical Inc
5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045
Injectable Drugs·372,912 affected·Oct 8, 2018
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
Medical Devices·46 affected·Oct 1, 2018
CriticalFDA
Oscor, Inc.
TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packa...
Cardiac Devices·36,688 affected·Sep 26, 2018
High RiskFDA
Pro-dex Inc
PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches -...
Surgical Devices·68 affected·Sep 25, 2018
High RiskFDA
Zimmer Biomet, Inc.
StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medica...
Medical Implants·72 affected·Sep 21, 2018
High RiskFDA
Pfizer Inc.
Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL...
Injectable Drugs·71,075 affected·Sep 20, 2018
High RiskFDA
Pfizer Inc.
Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc,...
Injectable Drugs·12,416 affected·Sep 19, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a ...
Medical Devices·158,163 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a...
Medical Devices·281,350 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a...
Medical Devices·136,800 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a...
Medical Devices·456,071 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to ...
Medical Devices·110,134 affected·Sep 12, 2018
High RiskFDA
Pharm D Solutions, Llc
Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1...
Injectable Drugs·9 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
HCG Lyopholized 1200 IU Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-1743-12
Injectable Drugs·881 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/20 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1366-02
Drugs·815 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a) Injectable NDC 69699-1332-05 b) (LYO) Powder NDC 69699-1332-05, Pharm D...
Injectable Drugs·609 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Sermorelin/GHRP-2 18 mg/6 mg powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1748-10
Drugs·124 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Bi-Mix Injection, (Alprostadil 40 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1305-03
Injectable Drugs·148 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Slenderella Compound Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1617-30
Injectable Drugs·5,000 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Sermorelin/GHRP-2 9 mg/9 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1715-10
Drugs·250 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Trimix BM3 Papaverine 30 mg/Phentolamine 1 mg Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1354-03
Injectable Drugs·20 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Trimix T 101 Alprostadil/Papverine/Phentolamine 5.9 mcg/17.65 mg/0.59 mcg per mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69...
Injectable Drugs·20 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Dexpanthenol Injection, 250 mg/mL Pharm D Solutions, Houston, Texas --- NDC 69699-1610-30
Injectable Drugs·2,000 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Trimix 30-1-30 Papavarin 30 mg/Phentolamine 1 mg/Alprostadil 30 mg/mL Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1...
Drugs·50 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1745-30
Injectable Drugs·580 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
HCG Lyophilized 5000 IU Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-1707-10
Injectable Drugs·2,219 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Beta-complex B-1, B-6, B-3, B-12, B-5 100, 2.54 Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1611-30
Injectable Drugs·6,000 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Tilarginine Acetate 50 mg/mL, 10 mL, Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1461-10
Injectable Drugs·3,523 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Prostaglandin E1 40 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1347-05
Injectable Drugs·154 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Tri-Mix XL 150 mg/10 mg/100 mcg a) Injectable NDC 69699-1353-10; b) (LYO) Powder NDC 69699-1353-10, Pharm D Solutions, Houston, Texas
Injectable Drugs·553 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Epi-Shugarcaine Kit Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1409-60
Drugs·70 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
HCG Reconstitued 6000 IU Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1739-06
Injectable Drugs·10 affected·Sep 10, 2018
High RiskFDA
Pharm D Solutions, Llc
Water Sterile for Injection 250 mL IV Pharm D Solutions, Houston, Texas --- NDC 69699-1407-25
Injectable Drugs·12 affected·Sep 10, 2018