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
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 5ML L/L RED NITRO Model/Catalog Number: 91866 Product Description: NON-Sterile syringes without ...
Medical Devices·9,800 affected·Apr 5, 2024
High RiskFDA
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: GMAX Product Name: SYR 20ML/LL syringe Model/Catalog Number: TS2220L-M Product Description: NON-Sterile syringes without n...
Medical Devices·2,491,600 affected·Apr 5, 2024
High RiskFDA
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 10ML L/S BLUE Model/Catalog Number: 91872 Product Description: NON-Sterile syringes without need...
Medical Devices·30,800 affected·Apr 5, 2024
High RiskFDA
Cook Medical Incorporated
EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
Medical Devices·1 affected·Apr 1, 2024
High RiskFDA
Karl Storz Endoscopy
LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
Medical Devices·85 affected·Apr 1, 2024
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D
Medical Devices·202 affected·Mar 27, 2024
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601
Medical Devices·64 affected·Mar 27, 2024
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D
Medical Devices·2,905 affected·Mar 27, 2024
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475
Medical Devices·98 affected·Mar 27, 2024
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403D
Medical Devices·128 affected·Mar 27, 2024
High RiskFDA
Integradose Compounding Services Llc
fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Min...
Injectable Drugs·187 affected·Mar 22, 2024
High RiskFDA
B. Braun Medical Inc
Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00
Injectable Drugs·7,800 affected·Mar 22, 2024
High RiskFDA
Zimmer, Inc.
ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile- Indicated for temporary in...
Medical Devices·0 affected·Mar 20, 2024
High RiskFDA
Zimmer, Inc.
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 16 Holes, 236 MM, Sterile- Indicated for temporary i...
Medical Devices·0 affected·Mar 20, 2024
High RiskFDA
Zimmer, Inc.
ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteot...
Medical Devices·0 affected·Mar 20, 2024
High RiskFDA
Zimmer, Inc.
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Sterile- Indicated for temporary ...
Medical Devices·0 affected·Mar 20, 2024
High RiskFDA
Zimmer, Inc.
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Sterile- Indicated for temporary in...
Medical Devices·0 affected·Mar 20, 2024
High RiskFDA
Zimmer, Inc.
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 12 Holes, 184 MM, Sterile- Indicated for temporary ...
Medical Devices·0 affected·Mar 20, 2024
High RiskFDA
Zimmer, Inc.
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile- Indicated for temporary in...
Medical Devices·0 affected·Mar 20, 2024
High RiskFDA
Zimmer, Inc.
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 12 Holes, 184 MM, Sterile- Indicated for temporary ...
Medical Devices·0 affected·Mar 20, 2024
High RiskFDA
Zimmer, Inc.
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Sterile- Indicated for temporary ...
Medical Devices·0 affected·Mar 20, 2024
High RiskFDA
Zimmer, Inc.
ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Sterile- Indicated for temporary i...
Medical Devices·0 affected·Mar 20, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in), Model Number 62000
Medical Devices·1,624 affected·Mar 19, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP¿ 3 mm Vessel Cannula Blunt Tip, Mode...
Medical Devices·5,719 affected·Mar 19, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.25 mm Intracoronar...
Medical Devices·1,410 affected·Mar 19, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent Catheter 10 Fr., M...
Cardiac Devices·13,954 affected·Mar 19, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009, b) DLP¿ 1.8 m ...
Medical Devices·6,290 affected·Mar 19, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic DLP Coronary Ostial Cannulae, Model Number 30050
Medical Devices·250 affected·Mar 19, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050, b) DLP¿ Suction Tube 6-Fr. Shaft wi...
Medical Devices·13,198 affected·Mar 19, 2024
High RiskFDA
Trimed Inc.
TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3...
Medical Devices·120 affected·Mar 19, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001
Medical Devices·7,935 affected·Mar 19, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP¿ 7 in (17.8 cm) Tourniquet Kit, Model ...
Medical Devices·1,760 affected·Mar 19, 2024
High RiskFDA
Trimed Inc.
TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3...
Medical Devices·142 affected·Mar 19, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic Clearview Blower/Mister, Model Number 22120
Medical Devices·500 affected·Mar 19, 2024
High RiskFDA
Xenex Disinfection Services Inc.
LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024, used with the LightStrike Germ-Za...
Medical Devices·377 affected·Mar 18, 2024
High RiskFDA
Merit Medical Systems, Inc.
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Medical Devices·18 affected·Mar 14, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing component Steril...
Surgical Devices·12,588 affected·Mar 14, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch with component Reor...
Surgical Devices·7,673 affected·Mar 14, 2024
High RiskFDA
Merit Medical Systems, Inc.
Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
Medical Devices·27 affected·Mar 14, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Medline Reorder #DY...
Surgical Devices·12,588 affected·Mar 14, 2024
High RiskFDA
Allergan Sales, Llc
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
Medical Devices·10,837 affected·Mar 14, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O....
Surgical Devices·7,673 affected·Mar 14, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorder #DYNJ04048, Kel...
Cardiac Devices·7,673 affected·Mar 14, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch with component M...
Cardiac Devices·12,588 affected·Mar 14, 2024
High RiskFDA
Eli Lilly & Company
Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-...
Injectable Drugs·700 affected·Mar 12, 2024
High RiskFDA
Hikma Pharmaceuticals Usa Inc.
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, ...
Drugs·22,644 affected·Mar 12, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Namic FLUID DELIVERY SET, REF 91300040
Medical Devices·50 affected·Mar 12, 2024
High RiskFDA
Medline Industries, Lp - Northfield
namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; ...
Cardiac Devices·570 affected·Mar 12, 2024