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
CriticalFDA
Route 92 Medical Inc
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovascul...
Medical Devices·117 affected·Mar 8, 2024
CriticalFDA
Route 92 Medical Inc
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the ne...
Surgical Devices·200 affected·Mar 8, 2024
CriticalFDA
Route 92 Medical Inc
Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into ...
Medical Devices·750 affected·Mar 8, 2024
CriticalFDA
Route 92 Medical Inc
Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neu...
Medical Devices·10 affected·Mar 8, 2024
High RiskFDA
B. Braun Medical Inc
Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18...
Injectable Drugs·22,752 affected·Mar 6, 2024
High RiskFDA
Thea Pharma, Inc.
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
Ophthalmic Drugs·5,476 affected·Mar 5, 2024
RecallFDA
Natural Waters Of Viti Limited
Fiji Natural Artesian Water 500 mL (24 pack) Case UPC Code: 6 32565 00004 3 Bottle UPC Code: 6 32565 00001 2
Beverages·78,533 affected·Mar 4, 2024
CriticalFDA
Thoratec Corp.
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
Medical Implants·882 affected·Mar 1, 2024
High RiskFDA
Cook Incorporated
Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into cent...
Surgical Devices·55 affected·Mar 1, 2024
High RiskFDA
Cook Incorporated
Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-v...
Surgical Devices·5,998 affected·Mar 1, 2024
High RiskFDA
Cook Incorporated
Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wa...
Surgical Devices·8 affected·Mar 1, 2024
High RiskFDA
Cook Incorporated
Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular a...
Surgical Devices·55 affected·Mar 1, 2024
High RiskFDA
Cook Incorporated
Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-va...
Surgical Devices·4,856 affected·Mar 1, 2024
High RiskFDA
Ssm Health Care St. Louis Dba Ssm St. Clare Health Center
Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded D...
Injectable Drugs·11,798 affected·Feb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 2...
Ophthalmic Drugs·24,216 affected·Feb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, Inc, 1575 Delucchi ...
Ophthalmic Drugs·30,240 affected·Feb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi L...
Ophthalmic Drugs·19,344 affected·Feb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite #...
Ophthalmic Drugs·10,536 affected·Feb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lan...
Ophthalmic Drugs·106,704 affected·Feb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite...
Ophthalmic Drugs·9,936 affected·Feb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Ren...
Ophthalmic Drugs·7,248 affected·Feb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi La...
Ophthalmic Drugs·139,656 affected·Feb 29, 2024
High RiskFDA
Ssm Health Care St. Louis Dba Ssm St. Clare Health Center
FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Offi...
Injectable Drugs·140 affected·Feb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 20...
Ophthalmic Drugs·47,832 affected·Feb 29, 2024
High RiskFDA
Optikem International, Inc.
hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Ri...
Ophthalmic Drugs·46,621 affected·Feb 29, 2024
High RiskFDA
Convatec, Inc
ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package,...
Medical Devices·63 affected·Feb 27, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/B SCISSOR 4-1/2" ...
Surgical Devices·568,849 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6
Medical Devices·100 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), P...
Medical Devices·80,903 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724
Medical Devices·2,458 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A
Medical Devices·4,200 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion STERILE #16 RUBBER BAND, Product Code EB16
Medical Devices·150 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNELL RETRACTOR (RR60...
Medical Devices·760 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Product Code 66520; b) STERILE TOWEL CLAMP, Product Code A...
Medical Devices·12,980 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723
Medical Devices·0 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT, Product Code MN...
Surgical Devices·1,335 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660; b) STERILE SMALL 2 PRONG SKIN HOOK (25754), P...
Medical Devices·1,520 affected·Feb 23, 2024
High RiskFDA
Bolton Medical Inc.
RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Pa...
Medical Implants·21 affected·Feb 22, 2024
High RiskFDA
Alcon Research, Llc
SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 56...
Surgical Devices·886 affected·Feb 21, 2024
High RiskFDA
Covidien
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Medical Devices·755,800 affected·Feb 21, 2024
High RiskFDA
Denver Solutions, Llc Dba Leiters Health
Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 137...
Injectable Drugs·40,090 affected·Feb 20, 2024
High RiskFDA
Medtronic Inc.
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Medical Implants·65 affected·Feb 16, 2024
High RiskFDA
Howmedica Osteonics Corp.
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Medical Devices·18 affected·Feb 6, 2024
High RiskFDA
Howmedica Osteonics Corp.
X3 TRIATHLON CS INSERT NO 6 10 MM
Medical Devices·143 affected·Feb 6, 2024
High RiskFDA
Howmedica Osteonics Corp.
X3 TRIATHLON CS INSERT NO 3 10 MM
Medical Devices·132 affected·Feb 6, 2024
High RiskFDA
Brassica Pharma Pvt Ltd
Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by Walmart Inc., Bento...
Topical Drugs·315,842 affected·Jan 30, 2024
High RiskFDA
Brassica Pharma Pvt Ltd
CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrolatum 57.7% Emollient), Packaged in in 3.5 gram tubes, Distri...
Topical Drugs·159,334 affected·Jan 30, 2024
High RiskFDA
Brassica Pharma Pvt Ltd
Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by: AACE Pharmaceuticals, I...
Topical Drugs·355,120 affected·Jan 30, 2024