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
Medtronic Perfusion Systems
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray...
Surgical Devices·1,236 affected·Apr 20, 2022
High RiskFDA
Progenacare
progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM300...
Medical Devices·547 affected·Apr 18, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Ipratropium Bromide Inhalation Solution, 0.02%, 0.5 mg/2.5 mL, packaged in 25-count box (25 x 2.5 mL sterile unit-dose vials), Rx only, M...
Drugs·57 affected·Apr 13, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Betadine 5%, Sterile Ophthalmic Prep Solution, (povidine-iodine ophthalmic solution), 1 fl. oz. (30 mL), Rx only, Mfd for: Alcon Surgical...
Ophthalmic Drugs·799 affected·Apr 13, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP, sterile, 0.1%, 10 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 6131462810
Ophthalmic Drugs·44 affected·Apr 13, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
BSS Sterile Irrigating Solution (balanced salt solution), 15 mL bottle, Rx only, MFG: Alcon Surgical Inc, NDC 0065-0795-15
Drugs·13 affected·Apr 13, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Recothrom Thrombin Topical (Recombinant), 5,000 units, packaged in a box containing a 5000-unit vial of RECOTHROM with a 5-mL prefilled d...
Topical Drugs·110 affected·Apr 13, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Sterile Water for Injection USP, 2000 mL, Rx only, Baxter Healthcare Corp., NDC 0338-0013-06
Injectable Drugs·0 affected·Apr 13, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
BSS Sterile Irrigating Solution (balanced salt solution), 500 mL bottle, Rx only, MFG: Alcon Surgical Inc, NDC 0065-0795-50
Drugs·4 affected·Apr 13, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Albuterol Sulfate Inhalation Solution, 0.021%, 0.63 mg/3mL, packaged in 30 x 3 mL Sterile Unit-Dose Vials, Rx only, MFG: Nephron Pharma, ...
Drugs·1 affected·Apr 13, 2022
High RiskFDA
Teleflex Medical Inc
(1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterile; (3) Gibeck Hu...
Medical Devices·59,581 affected·Apr 11, 2022
High RiskFDA
Radiometer Medical Aps
Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, ...
Medical Devices·7,228 affected·Apr 8, 2022
High RiskFDA
Xvivo Perfusion Ab
XVIVO Organ Chamber REF 19020
Medical Devices·80 affected·Apr 8, 2022
High RiskFDA
Johnson & Johnson Surgical Vision Inc
TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
Medical Devices·0 affected·Apr 6, 2022
High RiskFDA
North American Custom Laboratories, Llc Dba Farmakeio Superior Custom Compounding
PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
Injectable Drugs·43 affected·Apr 5, 2022
High RiskFDA
North American Custom Laboratories, Llc Dba Farmakeio Superior Custom Compounding
ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
Injectable Drugs·28 affected·Apr 5, 2022
High RiskFDA
North American Custom Laboratories, Llc Dba Farmakeio Superior Custom Compounding
Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
Injectable Drugs·35 affected·Apr 5, 2022
High RiskFDA
North American Custom Laboratories, Llc Dba Farmakeio Superior Custom Compounding
Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson,...
Injectable Drugs·189 affected·Apr 5, 2022
High RiskFDA
North American Custom Laboratories, Llc Dba Farmakeio Superior Custom Compounding
Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
Injectable Drugs·76 affected·Apr 5, 2022
High RiskFDA
North American Custom Laboratories, Llc Dba Farmakeio Superior Custom Compounding
BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
Injectable Drugs·778 affected·Apr 5, 2022
High RiskFDA
North American Custom Laboratories, Llc Dba Farmakeio Superior Custom Compounding
LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
Injectable Drugs·25 affected·Apr 5, 2022
High RiskFDA
Olympia Compounding Pharmacy Dba Olympia Pharmacy
Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF, Sterile Water for Injection USP, 10 mL Multi-Dose vial, Rx Only, Oly...
Injectable Drugs·45,935 affected·Apr 4, 2022
High RiskFDA
Hand Sanitizer Llc
HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80% Topical Non-Sterile Solution, 12 FL OZ (254 mL) bottles, Distributed by: Hand ...
Topical Drugs·24,020 affected·Apr 4, 2022
High RiskFDA
Beak & Skiff Cider Mill, Inc.
BEAK & SKIFF SANITIZER Alcohol Antiseptic 80%, Topical Solution Antiseptic Hand Rub Non-Sterile Solution, Packaged in a) 12OZ/355ML bottl...
Topical Drugs·396 affected·Apr 4, 2022
High RiskFDA
Restor3d Inc.
Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual...
Surgical Devices·14 affected·Mar 30, 2022
High RiskFDA
Plastikon Healthcare Llc
Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distr...
Oral Drugs·121,800 affected·Mar 24, 2022
High RiskFDA
Plastikon Healthcare Llc
Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, F...
Drugs·106,400 affected·Mar 24, 2022
High RiskFDA
Abbott
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
Surgical Devices·588 affected·Mar 24, 2022
High RiskFDA
Abbott
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
Surgical Devices·2,134 affected·Mar 24, 2022
High RiskFDA
Drug Depot, Inc., Dba Aps Pharmacy
TESTOSTERONE CYPIONATE/ ANASTROZOLE *GS* OIL (10ML) 200MG/0.5MG/ML; Packaged in a multi dose 10ML vial, as a) (CA) 4 ML Formula ID 136164...
Drugs·73 affected·Mar 23, 2022
High RiskFDA
Drug Depot, Inc., Dba Aps Pharmacy
GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS Pharmacy
Injectable Drugs·6,017 affected·Mar 23, 2022
High RiskFDA
Drug Depot, Inc., Dba Aps Pharmacy
TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 5 ML Formula ID 115678; b) 10 ML Form...
Injectable Drugs·620 affected·Mar 23, 2022
High RiskFDA
Drug Depot, Inc., Dba Aps Pharmacy
TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil (10 ML) 160MG/20MG/ML Injectable, Packaged in a multi dose 10ml vial, Formula ID 115498, APS ...
Injectable Drugs·0 affected·Mar 23, 2022
High RiskFDA
Drug Depot, Inc., Dba Aps Pharmacy
TESTOSTERONE CYPIONATE *GS* (2 mL) 80 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 127492, APS Pharmacy
Injectable Drugs·17 affected·Mar 23, 2022
High RiskFDA
Drug Depot, Inc., Dba Aps Pharmacy
TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 76681, APS Pharmacy
Injectable Drugs·24 affected·Mar 23, 2022
High RiskFDA
Drug Depot, Inc., Dba Aps Pharmacy
TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 4 ML Formula ID 115387; b...
Injectable Drugs·846 affected·Mar 23, 2022
High RiskFDA
Drug Depot, Inc., Dba Aps Pharmacy
(CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID136345, APS Pharmacy
Injectable Drugs·1,843 affected·Mar 23, 2022
High RiskFDA
Medtronic Vascular, Inc.
Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
Surgical Devices·3 affected·Mar 23, 2022
High RiskFDA
Medtronic Vascular, Inc.
Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04...
Surgical Devices·6 affected·Mar 23, 2022
High RiskFDA
American Contract Systems, Inc.
ACS Cath Lab Pack
Medical Devices·10 affected·Mar 22, 2022
High RiskFDA
American Contract Systems, Inc.
ACS Lap Chole Pack
Medical Devices·20 affected·Mar 22, 2022
High RiskFDA
Steris Corporation
Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Number: ENC100
Medical Devices·103 affected·Mar 22, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
Surgical Devices·486,578 affected·Mar 15, 2022
High RiskFDA
Vitae Enim Vitae Scientific, Inc.
TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for Cameron Pha...
Injectable Drugs·722 affected·Mar 14, 2022
High RiskFDA
Vitae Enim Vitae Scientific, Inc.
PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-415-25) and b) 3 x 1 mL Vials per box (ND...
Injectable Drugs·21,501 affected·Mar 14, 2022
High RiskFDA
Vitae Enim Vitae Scientific, Inc.
PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-416-25) and b) 3 x 1mL Vials per box (N...
Injectable Drugs·18,531 affected·Mar 14, 2022
High RiskFDA
Vitae Enim Vitae Scientific, Inc.
PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 72516-024-25) and b)...
Injectable Drugs·2,098 affected·Mar 14, 2022
High RiskFDA
Olympia Compounding Pharmacy Dba Olympia Pharmacy
Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per vial, Each ML contains: 5% Mannitol USP, Sterile Water for ...
Injectable Drugs·2,283 affected·Mar 8, 2022