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
Deroyal Industries Inc
Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, S...
Surgical Devices·1,391 affected·Apr 17, 2023
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder 115 South 40th Ave, Suite A Hattiesburg, MS 39402
Injectable Drugs·45 affected·Apr 13, 2023
High RiskFDA
Sanofi-aventis U.s. Llc
Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A S...
Injectable Drugs·51,325 affected·Apr 11, 2023
High RiskFDA
3m Company - Health Care Business
3M Attest Steam Chemical Integrators, REF 1243B
Medical Devices·2,235,000 affected·Apr 6, 2023
High RiskFDA
Karl Storz Endoscopy
Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF: 11580B; Metal Tray, 373 x 178 x 35 mm, REF: 11580C; Me...
Medical Devices·4,933 affected·Apr 6, 2023
High RiskFDA
Cardinal Health 200, Llc
Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Medical Devices·5 affected·Apr 6, 2023
High RiskFDA
Smiths Medical Asd Inc.
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breat...
Medical Devices·47,007 affected·Apr 5, 2023
High RiskFDA
Karl Storz Endoscopy
KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
Medical Devices·4,386 affected·Apr 5, 2023
High RiskFDA
Smiths Medical Asd Inc.
DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with b...
Medical Devices·14,941 affected·Apr 5, 2023
RecallFDA
Accord Healthcare, Inc.
Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutaneous Use Only, Rx...
Injectable Drugs·4,574 affected·Mar 29, 2023
High RiskFDA
Surgical Innovations Ltd
YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
Medical Devices·3,405 affected·Mar 28, 2023
High RiskFDA
Jarman's Midwest Cleaning Systems, Inc.
Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midw...
Topical Drugs·1,276 affected·Mar 27, 2023
High RiskFDA
Baxter Healthcare Corporation
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporat...
Drugs·9,788 affected·Mar 15, 2023
High RiskFDA
Baxter Healthcare Corporation
Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II Container bag, P...
Drugs·95,448 affected·Mar 15, 2023
High RiskFDA
Maquet Cardiovascular, Llc
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
Medical Devices·2,300 affected·Mar 6, 2023
High RiskFDA
Maquet Cardiovascular, Llc
VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W
Medical Devices·235 affected·Mar 6, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
Medical Devices·162 affected·Mar 2, 2023
High RiskFDA
Stryker Corporation
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for us...
Surgical Devices·1,225 affected·Mar 1, 2023
High RiskFDA
Stryker Corporation
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Catalog number: 5921-030-235NS Indicated for ...
Surgical Devices·1,206 affected·Mar 1, 2023
High RiskFDA
Stryker Corporation
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS
Medical Devices·1,730 affected·Mar 1, 2023
High RiskFDA
Covidien, Lp
Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V2...
Medical Devices·36,204 affected·Mar 1, 2023
High RiskFDA
Nephron Sc Inc
Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, SC 29172, NDC 048...
Injectable Drugs·325,080 affected·Feb 23, 2023
High RiskFDA
Teva Pharmaceuticals Usa Inc
Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL (0.085 f...
Ophthalmic Drugs·715,632 affected·Feb 23, 2023
High RiskFDA
Nephron Sterile Compounding Center Llc
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, package...
Injectable Drugs·270,291 affected·Feb 22, 2023
High RiskFDA
Nephron Sterile Compounding Center Llc
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per c...
Injectable Drugs·546,450 affected·Feb 22, 2023
High RiskFDA
Nephron Sterile Compounding Center Llc
Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 ...
Injectable Drugs·10,980 affected·Feb 22, 2023
High RiskFDA
Nephron Sterile Compounding Center Llc
Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bott...
Injectable Drugs·4,743 affected·Feb 22, 2023
High RiskFDA
Nephron Sterile Compounding Center Llc
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, ...
Injectable Drugs·31,500 affected·Feb 22, 2023
High RiskFDA
Nephron Sterile Compounding Center Llc
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged...
Injectable Drugs·305,895 affected·Feb 22, 2023
High RiskFDA
Nephron Sterile Compounding Center Llc
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 ...
Injectable Drugs·443,483 affected·Feb 22, 2023
High RiskFDA
Nephron Sterile Compounding Center Llc
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, ...
Injectable Drugs·24,870 affected·Feb 22, 2023
High RiskFDA
Biosense Webster, Inc.
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
Medical Devices·277 affected·Feb 21, 2023
High RiskFDA
Mani, Inc. - Kiyohara Facility
Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with...
Medical Devices·45 affected·Feb 20, 2023
CriticalFDA
Pharmedica Usa, Llc
Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9; and b) 30 ml, 1.014 fl oz bottle, UPC 7 31034 9...
Drugs·869 affected·Feb 14, 2023
High RiskFDA
Maquet Medical Systems Usa
BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. ...
Respiratory Devices·10,587 affected·Feb 13, 2023
High RiskFDA
Apollo Care
Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mo...
Drugs·215 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRA...
Medical Devices·10,037 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S4...
Medical Devices·19,057 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115; c) DBM T44105...
Medical Devices·5,308 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206; c) DB...
Medical Devices·4,348 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c) DBM T41110 0.5C...
Medical Devices·10,090 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF ...
Medical Devices·30,541 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S4...
Medical Devices·37,721 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS...
Medical Devices·23,850 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S431...
Medical Devices·186,889 affected·Feb 8, 2023
High RiskFDA
Labories Medical Technologies
injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge
Medical Devices·415,480 affected·Feb 7, 2023
High RiskFDA
Leadiant Biosciences, Inc.
Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN 46268; D...
Injectable Drugs·31,879 affected·Feb 3, 2023
High RiskFDA
Synthes (usa) Products Llc
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur...
Medical Devices·6 affected·Feb 1, 2023