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 Inc
Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consi...
Cardiac Devices·16 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consi...
Medical Devices·80 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist o...
Medical Devices·20 affected·Sep 14, 2020
High RiskFDA
Genesis Partnership Company Sa
Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon (3785 mL) bottle, Manufactured by Genesis Partnership Compan...
Topical Drugs·5,040 affected·Sep 11, 2020
High RiskFDA
Genesis Partnership Company Sa
Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 240 mL (8 FL OZ.) bottle, Manufactured by Genesis Partnership Company...
Topical Drugs·15,000 affected·Sep 11, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
Medical Devices·0 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996
Medical Devices·0 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626
Medical Devices·0 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Biomet, Inc.
Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055
Medical Devices·33 affected·Sep 4, 2020
High RiskFDA
Biomet, Inc.
Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055
Medical Devices·4 affected·Sep 4, 2020
High RiskFDA
Biomet, Inc.
Biomet Regenerex Primary Taper Cap Item Number 141269
Medical Devices·62 affected·Sep 4, 2020
High RiskFDA
Braxton Medical Corporation
B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to ...
Surgical Devices·1,781 affected·Sep 4, 2020
High RiskFDA
Akorn, Inc.
Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, ND...
Ophthalmic Drugs·25,843 affected·Sep 3, 2020
High RiskFDA
Biomet, Inc.
(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 1100104...
Medical Devices·48 affected·Sep 3, 2020
High RiskFDA
Charles Paint Research Inc
HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 g...
Topical Drugs·600 affected·Sep 2, 2020
High RiskFDA
Charles Paint Research Inc
HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 g...
Topical Drugs·3,900 affected·Sep 2, 2020
High RiskFDA
Wright Medical Technology Inc
EVOLVE STEM 8.5MM Model # 496S085
Medical Devices·16 affected·Aug 26, 2020
High RiskFDA
Genicon, Inc.
Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures ...
Surgical Devices·10,808 affected·Aug 25, 2020
High RiskFDA
North American Rescue Llc.
4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as follows: a) M-FAK Mini First Aid Kit; ...
Medical Devices·11,404 affected·Aug 21, 2020
High RiskFDA
Family Pharmacy Of Statesville
Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Drugs·1 affected·Aug 6, 2020
High RiskFDA
Family Pharmacy Of Statesville
Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.
Injectable Drugs·5 affected·Aug 6, 2020
High RiskFDA
Family Pharmacy Of Statesville
Methylcobalamin 1 mg/mL Injectable in 1 mL syringes, Rx only, Family Pharmacy of Statesville, Inc.
Injectable Drugs·5 affected·Aug 6, 2020
High RiskFDA
Family Pharmacy Of Statesville
Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Drugs·1 affected·Aug 6, 2020
High RiskFDA
Family Pharmacy Of Statesville
Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of Statesville, Inc.
Drugs·8 affected·Aug 6, 2020
High RiskFDA
Family Pharmacy Of Statesville
Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Drugs·3 affected·Aug 6, 2020
High RiskFDA
Family Pharmacy Of Statesville
Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Drugs·2 affected·Aug 6, 2020