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 Innovations
Chlorpheniramine/Hyoscyamine (1ML) 10MG/0.25MG/ML Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Injectable Drugs·0 affected·Dec 22, 2022
High RiskFDA
Pharmacy Innovations
Ethyl Alcohol 95% (5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Injectable Drugs·0 affected·Dec 22, 2022
High RiskFDA
Pharmacy Innovations
LIDOCAINE-PF- 5% (5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Injectable Drugs·0 affected·Dec 22, 2022
High RiskFDA
Pharmacy Innovations
DEXAMETHASONE 16MG/ML (3ML VIAL) INJECTABLE; DEXAMETHASONE 24MG/ML INJECTABLE; DEXAMETHASONE-PF- 0.1% (1ML DROPPER) OPH SOLUTION, Rx Only...
Injectable Drugs·0 affected·Dec 22, 2022
High RiskFDA
Pharmacy Innovations
PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID (10ML VIAL) 50MG/50MG/ML (5%/5%) INJECTABLE; Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Injectable Drugs·0 affected·Dec 22, 2022
High RiskFDA
Pharmacy Innovations
GLYCERIN STERILE 99% 2ML VIAL and 5ML VIAL, Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Injectable Drugs·0 affected·Dec 22, 2022
High RiskFDA
Beaver Visitec International, Inc.
Ultracell Wick with 80cc Collection Bag, 20/box
Medical Devices·4,640 affected·Dec 20, 2022
High RiskFDA
Stradis Healthcare
McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.
Medical Devices·250 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
Medical Devices·112,675 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.
Medical Devices·76,260 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.
Medical Devices·80 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology
Medical Devices·200 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Medical Devices·275 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Surgical Devices·920 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.
Medical Devices·200 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.
Medical Devices·300 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Medical Devices·2,779 affected·Dec 15, 2022
High RiskFDA
Biomet, Inc.
Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femo...
Medical Devices·7 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0...
Medical Devices·21,755 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group
Medical Devices·2,500 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Medical Devices·1,175 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.
Medical Devices·1,040 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
PICC KIT, 10/CS, ACCESS MEDICAL LABEL
Medical Devices·180 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.
Medical Devices·600 affected·Dec 15, 2022
High RiskFDA
Steris Corporation
VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and routine monitoring ...
Medical Devices·105 affected·Dec 12, 2022
High RiskFDA
Steris Corporation
VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installation testing and...
Medical Devices·857 affected·Dec 12, 2022
High RiskFDA
Nch Life Sciences Llc
Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464 ml), NDC 55533-52...
Topical Drugs·10,930 affected·Dec 9, 2022
High RiskFDA
Mcguff Compounding Pharmacy Services, Inc.
Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 2 mL Ste...
Injectable Drugs·11 affected·Dec 8, 2022
High RiskFDA
Mcguff Compounding Pharmacy Services, Inc.
Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 30...
Injectable Drugs·255 affected·Dec 8, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
Surgical Devices·0 affected·Dec 7, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY, Reorder Number MNS9065
Surgical Devices·138 affected·Dec 7, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224B
Surgical Devices·60 affected·Dec 7, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Surgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYNDL1643A
Surgical Devices·1,376 affected·Dec 7, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PICC TRAY, Reorder Number CVI4685
Surgical Devices·60 affected·Dec 7, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA2827
Surgical Devices·80 affected·Dec 7, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1122A
Surgical Devices·120 affected·Dec 7, 2022
CriticalFDA
Covidien Lp
MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensions, Kit - Model ...
Surgical Devices·359,730 affected·Dec 7, 2022
High RiskFDA
Turbett Surgical, Inc.
Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Surgical Devices·6 affected·Dec 5, 2022
High RiskFDA
Turbett Surgical, Inc.
Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Surgical Devices·61 affected·Dec 5, 2022
High RiskFDA
Covidien, Lp
Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861...
Medical Devices·87,708 affected·Dec 2, 2022
High RiskFDA
Covidien, Lp
Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM C12 (3) 8886174...
Medical Devices·9,606 affected·Dec 2, 2022
High RiskFDA
Covidien, Lp
Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK
Medical Devices·9,606 affected·Dec 2, 2022
High RiskFDA
Covidien, Lp
Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM ...
Medical Devices·40,152 affected·Dec 2, 2022
High RiskFDA
Covidien, Lp
Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA
Medical Devices·2,070 affected·Dec 2, 2022
High RiskFDA
Tomy International Inc.
Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L
Medical Devices·55,000 affected·Dec 2, 2022
High RiskFDA
Covidien, Lp
Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOFSILK* 2-0 BLK 75...
Medical Devices·271,800 affected·Dec 2, 2022
High RiskFDA
Covidien, Lp
Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM ...
Medical Devices·54,288 affected·Dec 2, 2022
High RiskFDA
Covidien, Lp
Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X ...
Medical Devices·322,152 affected·Dec 2, 2022