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
Carolina Infusion
MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs·4 affected·Aug 26, 2022
High RiskFDA
Carolina Infusion
TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs·348 affected·Aug 26, 2022
High RiskFDA
Carolina Infusion
QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs·1 affected·Aug 26, 2022
High RiskFDA
Carolina Infusion
Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs·4 affected·Aug 26, 2022
High RiskFDA
Carolina Infusion
TEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs·2 affected·Aug 26, 2022
High RiskFDA
Carolina Infusion
MIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs·3 affected·Aug 26, 2022
High RiskFDA
Carolina Infusion
TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs·3 affected·Aug 26, 2022
High RiskFDA
Carolina Infusion
Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs·8 affected·Aug 26, 2022
High RiskFDA
Carolina Infusion
TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs·2 affected·Aug 26, 2022
High RiskFDA
Carolina Infusion
Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs·24 affected·Aug 26, 2022
High RiskFDA
Carolina Infusion
TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland...
Injectable Drugs·3 affected·Aug 26, 2022
High RiskFDA
Carolina Infusion
TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs·16 affected·Aug 26, 2022
High RiskFDA
Carolina Infusion
TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs·1 affected·Aug 26, 2022
High RiskFDA
Carolina Infusion
TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs·1 affected·Aug 26, 2022
High RiskFDA
Carolina Infusion
TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs·2 affected·Aug 26, 2022
High RiskFDA
Carolina Infusion
TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs·7 affected·Aug 26, 2022
High RiskFDA
Carolina Infusion
Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs·4 affected·Aug 26, 2022
High RiskFDA
Carolina Infusion
L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs·1 affected·Aug 26, 2022
High RiskFDA
Carolina Infusion
TRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs·11 affected·Aug 26, 2022
High RiskFDA
Carolina Infusion
QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs·1 affected·Aug 26, 2022
High RiskFDA
Zimmer, Inc.
G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
Medical Devices·56 affected·Aug 25, 2022
High RiskFDA
Cook Incorporated
Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902 TSCF-21-260-3...
Medical Devices·9,903 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-...
Medical Devices·25 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-30 G02791 CTU14.0...
Medical Devices·240 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561
Medical Devices·42 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09...
Medical Devices·488 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
Medical Devices·115 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-...
Medical Devices·5,041 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH...
Medical Devices·204 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476
Medical Devices·58 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146 TDOC-35-50-0-3 ...
Medical Devices·150 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-CO...
Medical Devices·2,748 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304
Medical Devices·149 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-03...
Medical Devices·56 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
Medical Devices·363 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 ...
Medical Devices·5,571 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G27033
Medical Devices·0 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677
Medical Devices·0 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)
Medical Devices·43 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-...
Medical Devices·1,236 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
Medical Devices·0 affected·Aug 16, 2022
High RiskFDA
Deroyal Industries Inc
DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
Medical Devices·1,306 affected·Aug 12, 2022
RecallFDA
Steris Corporation Hopkins Facility
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging te...
Medical Devices·619 affected·Aug 10, 2022
High RiskFDA
Hologic, Inc
The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker i...
Medical Implants·233 affected·Aug 9, 2022
RecallFDA
Akorn, Inc
Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Fore...
Ophthalmic Drugs·5,226 affected·Aug 8, 2022
High RiskFDA
Collagen Matrix Inc
Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytopla...
Medical Devices·1,336 affected·Aug 3, 2022
High RiskFDA
Cipla
Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured ...
Ophthalmic Drugs·7,992 affected·Aug 2, 2022
High RiskFDA
Carwild Corporation
FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Numb...
Medical Devices·90 affected·Aug 2, 2022