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
Teva Pharmaceuticals Usa
Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva ...
Injectable Drugs·34,100 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort ...
Oral Drugs·4,587 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort...
Oral Drugs·4,992 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-...
Injectable Drugs·16,644 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Do...
Injectable Drugs·50,713 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, ND...
Injectable Drugs·2,091 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceuticals USA, Inc. Nor...
Injectable Drugs·42,046 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3...
Injectable Drugs·3,067 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-33...
Injectable Drugs·6,184 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7...
Injectable Drugs·16,226 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort ...
Oral Drugs·9,655 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC...
Injectable Drugs·476,275 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Memphis, TN 38141, ...
Injectable Drugs·20,800 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 1945...
Injectable Drugs·4,712 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx only, Teva Pharmace...
Injectable Drugs·2,199 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 07...
Injectable Drugs·25,653 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01
Injectable Drugs·62,358 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only, Manufactured by: Teva Pharmaceuticals USA Inc. Parsippany...
Injectable Drugs·4,249 affected·Jul 29, 2021
High RiskFDA
Clarus Medical, Llc
Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
Medical Devices·858 affected·Jul 27, 2021
High RiskFDA
Aspen Surgical Products, Inc.
Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
Medical Devices·124 affected·Jul 23, 2021
High RiskFDA
Mivi Neuroscience Inc
MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, ...
Surgical Devices·68 affected·Jul 23, 2021
High RiskFDA
Mivi Neuroscience Inc
MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm le...
Surgical Devices·491 affected·Jul 23, 2021
High RiskFDA
Baxter Healthcare Corporation
Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management an...
Medical Devices·1,976 affected·Jul 22, 2021
High RiskFDA
Baxter Healthcare Corporation
Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 S...
Medical Devices·64,275 affected·Jul 22, 2021
High RiskFDA
Merit Medical Systems, Inc.
MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Sing...
Medical Devices·373 affected·Jul 21, 2021
High RiskFDA
W. L. Gore & Associates Inc.
Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", S...
Surgical Devices·3,364 affected·Jul 12, 2021
High RiskFDA
Innoveix Pharmaceuticals Inc
Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, T...
Injectable Drugs·728 affected·Jul 9, 2021
High RiskFDA
Innoveix Pharmaceuticals Inc
Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800...
Injectable Drugs·1,316 affected·Jul 9, 2021
High RiskFDA
Ortho8, Inc.
CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, ...
Medical Devices·0 affected·Jul 9, 2021
High RiskFDA
Medtronic Neuromodulation
Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
Medical Devices·1,131 affected·Jul 9, 2021
High RiskFDA
Edwards Lifesciences, Llc
Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Steril...
Surgical Devices·152 affected·Jul 9, 2021
High RiskFDA
Edwards Lifesciences, Llc
Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommen...
Surgical Devices·178 affected·Jul 9, 2021
High RiskFDA
Edwards Lifesciences, Llc
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recomm...
Surgical Devices·70 affected·Jul 9, 2021
High RiskFDA
Vascutek, Ltd.
The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Tri...
Medical Implants·159 affected·Jul 8, 2021
High RiskFDA
Promise Pharmacy, Llc
MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile, Rx only, Promise Phar...
Injectable Drugs·57 affected·Jun 30, 2021
High RiskFDA
Cascade Kelly Holdings Llc
Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 8 fl. oz./236 mL, Alcohol 80% v/v, Ma...
Topical Drugs·0 affected·Jun 30, 2021
High RiskFDA
Cascade Kelly Holdings Llc
Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 4 fl. oz./119 mL, Alcohol 80% v/v, Ma...
Topical Drugs·0 affected·Jun 30, 2021
High RiskFDA
Merit Medical Systems, Inc.
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 008844504...
Cardiac Devices·760 affected·Jun 30, 2021
High RiskFDA
Delta Med Spa
NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
Surgical Devices·5,000 affected·Jun 21, 2021
High RiskFDA
Delta Med Spa
NEO DELTA Self Safe, I.V. Catheter REF 3738222
Surgical Devices·10,000 affected·Jun 21, 2021
High RiskFDA
Delta Med Spa
NEO DELTA SELFSAFE PUR T, I.V. Catheter:
Surgical Devices·0 affected·Jun 21, 2021
High RiskFDA
Delta Med Spa
NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
Surgical Devices·20,000 affected·Jun 21, 2021
High RiskFDA
Delta Med Spa
DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3...
Surgical Devices·203,680 affected·Jun 21, 2021
High RiskFDA
Delta Med Spa
NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822
Surgical Devices·14,000 affected·Jun 21, 2021
High RiskFDA
Delta Med Spa
WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
Surgical Devices·40,000 affected·Jun 21, 2021
High RiskFDA
Medicalplastic S.r.l.
Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
Medical Devices·581 affected·Jun 17, 2021
High RiskFDA
Arthrex, Inc.
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Medical Devices·3,985 affected·Jun 14, 2021
High RiskFDA
Axonics Modulation Technologies, Inc.
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Medical Devices·2,702 affected·Jun 3, 2021