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
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880; 2) DENTAL PACK, Model Number: DYNJ56...
Medical Devices·573 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, Model Number: DYNJ907733B
Medical Devices·116 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number: DYNJ69733; 2) NHS - LAP BOWEL GNG, Model Number: ...
Medical Devices·706 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT PACK, Model Numb...
Medical Implants·354 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number: MNS6270
Medical Devices·48 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF, Model Number: DYNJ0371999G;
Medical Devices·8 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF, Model Number: DYNJ40229A; 2) ARTHROSCOPY PACK-LF, M...
Medical Devices·222 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOGRAPHY TRAY-LF, Mo...
Medical Devices·2,118 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model Number: DYNJ44949C; 2) PICC LINE INSERTION BJC-LF,...
Medical Devices·3,808 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 2) PLASTIC PACK, Model Numb...
Medical Devices·4,094 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model Number: DYNJ66514;...
Medical Devices·9,216 affected·Mar 3, 2025
High RiskFDA
Amgen, Inc.
Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solu...
Injectable Drugs·313,620 affected·Feb 27, 2025
High RiskFDA
Amgen, Inc.
Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use...
Injectable Drugs·258,750 affected·Feb 27, 2025
High RiskFDA
Stryker Corporation
Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL
Medical Devices·0 affected·Feb 25, 2025
RecallFDA
Imprimis Njof, Llc
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Impri...
Ophthalmic Drugs·2,822 affected·Feb 24, 2025
High RiskFDA
Omnicell, Inc.
IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, ...
Medical Devices·3 affected·Feb 20, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2; 2) MJ BANDAGE HYDROCOLLOID ALL PURP 10C...
Medical Devices·1,894,488 affected·Feb 19, 2025
High RiskFDA
Turbare Manufacturing
Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug pro...
Injectable Drugs·1,147 affected·Feb 18, 2025
High RiskFDA
Medline Industries, Lp - Northfield
CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medli...
Drugs·1,639,996 affected·Feb 17, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medli...
Drugs·6,669,874 affected·Feb 17, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,...
Surgical Devices·1,490 affected·Feb 13, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.
Surgical Devices·1,118 affected·Feb 13, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
Surgical Devices·220 affected·Feb 13, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. ...
Surgical Devices·2,422 affected·Feb 13, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
Surgical Devices·506 affected·Feb 13, 2025
High RiskFDA
Wuxi Medical Lnstrument Factory Co., Ltd.
ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manuf...
Drugs·37,500 affected·Feb 12, 2025
High RiskFDA
Nephron Sterile Compounding Center Llc
Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, N...
Injectable Drugs·4,190 affected·Feb 10, 2025
High RiskFDA
Immuno-mycologics, Inc
Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates ...
Medical Devices·30 affected·Feb 10, 2025
High RiskFDA
Cardiofocus, Inc.
CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of a...
Cardiac Devices·833 affected·Feb 7, 2025
High RiskFDA
American Contract Systems Inc
MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
Medical Devices·147 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
LABOR & DELIVERY PACK, Model Nos LLLD19H
Medical Devices·725 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
Medical Devices·1,420 affected·Feb 6, 2025
High RiskFDA
Integra Lifesciences Corp.
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catal...
Medical Devices·623 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
Medical Devices·534 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
C-SECTION PACK, Model Nos LLCS44F LLCS44F-01
Medical Devices·252 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
DIAGNOSTIC NEURO IR TRAY , Model No WENE21
Diagnostic Devices·170 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
DELIVERY PACK , Model No SGDV22D-01 SGDV22E
Medical Devices·36 affected·Feb 6, 2025