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
Pharm D Solutions, Llc
Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1...
Drugs·85 affected·Nov 19, 2018
High RiskFDA
Howmedica Osteonics Corp.
HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE
Medical Devices·0 affected·Nov 15, 2018
CriticalFDA
Rvo 2.0, Inc
Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
Medical Devices·2,869 affected·Nov 13, 2018
High RiskFDA
Bracco Injeneering S.a.
Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT¿, EmpowerCTA¿ and EmpowerCTA¿+ Injector Syste...
Medical Devices·33,350 affected·Nov 12, 2018
High RiskFDA
Allergan
INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only, packaged in 2 mL Sterile Single Dose Vial, Mfd by Path...
Injectable Drugs·111,132 affected·Nov 8, 2018
CriticalFDA
Kadesh International
puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0.
Drugs·18,521 affected·Nov 5, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSite L25 series transducers. ...
Medical Devices·115 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers.
Medical Devices·73 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transdu...
Medical Devices·297 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx.
Medical Devices·49 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile needle guides (1cm, 1.5cm, 2cm depths) with (10.2 ...
Medical Devices·20 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) n...
Medical Devices·234 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122-04, and P03122-...
Medical Devices·1,375 affected·Nov 2, 2018
High RiskFDA
Civco Medical Instruments Co., Inc.
CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket with sterile needle guides (1.5cm, 2.5cm, 3.5cm, 4.5 depths) wi...
Medical Devices·468 affected·Nov 2, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in normject syringe) Repackaged by Avella Specialty Pharmacy, 24...
Drugs·911 affected·Oct 31, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Den...
Medical Implants·53 affected·Oct 26, 2018
High RiskFDA
Merit Medical Systems, Inc.
Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
Medical Devices·88 affected·Oct 26, 2018
High RiskFDA
Intuitive Surgical, Inc.
da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Medical Devices·1,818 affected·Oct 25, 2018
RecallFDA
Neomed Inc
NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral Only Extension Set is intended for use...
Medical Devices·654 affected·Oct 24, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2237-033-00 Product Usage: A...
Medical Implants·2,080 affected·Oct 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-026-00 Prod...
Medical Implants·780 affected·Oct 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2255-008-01 Product Usage: A single use surgi...
Medical Implants·48,320 affected·Oct 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
Medical Devices·8 affected·Oct 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-037-00 Product Usage: A...
Medical Implants·9,387 affected·Oct 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108
Medical Devices·8 affected·Oct 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-025-00 Product U...
Medical Implants·4,122 affected·Oct 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product...
Medical Implants·1,676 affected·Oct 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Item Number: 47-2255-008-00 Product Usage: A single use surgical ...
Medical Implants·8,027 affected·Oct 22, 2018
High RiskFDA
Wom World Of Medicine Ag
PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combinat...
Diagnostic Devices·124,180 affected·Oct 22, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
Phenylephrine 25 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
Drugs·300 affected·Oct 19, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
Morphine (1 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
Drugs·1,360 affected·Oct 19, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
Phenylephrine 30 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
Drugs·300 affected·Oct 19, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
Fentanyl (10 mcg/mL) in NS 1 mL (in 3mL BD Syringe), Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, I...
Drugs·20 affected·Oct 19, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
Hydromorphone (0.2 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
Drugs·360 affected·Oct 19, 2018
High RiskFDA
Qualgen, Llc
Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC, Edmond, OK 73013
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06), 12 count (NDC 69761-150-12), and 30 count (NDC 69761-15...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-3...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 69761-110-12), and 30 count (NDC 69761-1...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Testosterone 200 mg/Anastrozole 20 mg pellet, 1 count (NDC 69761-222-01), 6 count (NDC 69761-222-06), 12 count (NDC 69761-222-12), and 30...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 12 count (NDC 69761-018-12), and 30 count (NDC 69761-018-3...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-06), 12 count (NDC 69761-137-12) and 30 count (NDC 69761-...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06), 12 count (NDC 69761-120-12), and 30 count (NDC 69761-1...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-187-06), 12 count (NDC 69761-187-12), and 30 count (NDC 69761-...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06), 12 count (NDC 69761-025-12), and 30 count (NDC 69761-025-3...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-06), 12 count (NDC 69761-112-12), and 30 count (NDC 69761-...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Estradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06), 12 count (NDC 69761-006-12), and 30 count (NDC 69761-006-3...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 12 count (NDC 69761-010-12), and 30 count (NDC 69761-010-3...
Drugs·0 affected·Oct 17, 2018