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
Avella Of Deer Valley, Inc. Store 38
Vancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose Inj. (USP) 250 mL) Volume: 262 mL. Single dose bag. Avella S...
Drugs·1,352 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
EPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX ...
Drugs·700 affected·Jun 12, 2018
High RiskFDA
Teleflex Medical Europe Ltd
Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage: general surgical scissors
Surgical Devices·573 affected·Jun 12, 2018
High RiskFDA
Cardinal Health 200, Llc
Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Double Spike, Ref ASU1211, packaged 1/box, 12 boxes/case, single use, RX, Steri...
Medical Devices·63,020 affected·Jun 11, 2018
High RiskFDA
Cardinal Health 200, Llc
Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Double Spike, Ref ASC1201, pac...
Medical Devices·63,020 affected·Jun 11, 2018
High RiskFDA
Cardinal Health 200, Llc
Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Single Spike, Ref ASU1200, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Medical Devices·63,020 affected·Jun 11, 2018
High RiskFDA
Cardinal Health 200, Llc
Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Single Spike and no Probe, Ref ASC1220, packaged 1/box, 12 boxes/cas...
Medical Devices·63,020 affected·Jun 11, 2018
High RiskFDA
Cardinal Health 200, Llc
Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Single Spike, Ref ASC1200, pac...
Medical Devices·63,020 affected·Jun 11, 2018
High RiskFDA
Cardinal Health 200, Llc
Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Single Spike, Ref ASU1210, packaged 1/box, 12 boxes/case, single use, RX, Steri...
Medical Devices·63,020 affected·Jun 11, 2018
High RiskFDA
Canadian Hospital Specialties
MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector...
Medical Devices·10 affected·Jun 11, 2018
High RiskFDA
Cardinal Health 200, Llc
Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Double Spike, Ref ASU1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Medical Devices·63,020 affected·Jun 11, 2018
High RiskFDA
Cardinal Health 200, Llc
Hydroline Trumpet Valve, Trumpet Valve, No Probe, Single Spike, Ref ASU1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Medical Devices·63,020 affected·Jun 11, 2018
High RiskFDA
Cardinal Health 200, Llc
Hydroline Trumpet Valve, Trumpet Valve, No Probe, Double Spike, Ref ASU1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Medical Devices·63,020 affected·Jun 11, 2018
High RiskFDA
Cardinal Health 200, Llc
Hydroline Trumpet Valve with Pulse Wave Cassette, Cassette Trumpet Valve with Bariatric Probe, Double Spike, Ref ABP1201, packaged 1/box,...
Medical Devices·63,020 affected·Jun 11, 2018
High RiskFDA
Stryker Neurovascular
Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, STERILE: EO - Product Usage: pro...
Medical Devices·13,503 affected·Jun 8, 2018
High RiskFDA
Stryker Neurovascular
Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326320, REF 2632, STERILE:EO - Product...
Medical Devices·107 affected·Jun 8, 2018
High RiskFDA
Stryker Neurovascular
Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, STERILE: EO - Product Usage: ...
Medical Devices·21,971 affected·Jun 8, 2018
High RiskFDA
Stryker Neurovascular
Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326520, REF 2652, STERILE: EO - Prod...
Medical Devices·305 affected·Jun 8, 2018
High RiskFDA
Stryker Neurovascular
Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Product No. M00326510, REF 2651, STERILE:EO - Product Usage: pr...
Medical Devices·2,421 affected·Jun 8, 2018
High RiskFDA
Stryker Neurovascular
Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642, STERILE: EO - Prod...
Medical Devices·6,269 affected·Jun 8, 2018
High RiskFDA
Pharmalucence, Inc.
Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC 45567-0040-1), b) 30-count box...
Drugs·95 affected·Jun 6, 2018
High RiskFDA
Stryker Neurovascular
Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE...
Medical Implants·11,585 affected·Jun 5, 2018
High RiskFDA
Cryolife, Inc.
BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard methods of achiev...
Surgical Devices·855 affected·Jun 4, 2018
High RiskFDA
Nakanishi Inc.
Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typ...
Medical Implants·12 affected·Jun 1, 2018
High RiskFDA
Nakanishi Inc.
Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Ty...
Medical Implants·18 affected·Jun 1, 2018
High RiskFDA
Nakanishi Inc.
Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are int...
Medical Implants·1,662 affected·Jun 1, 2018
High RiskFDA
Nakanishi Inc.
Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are i...
Medical Implants·440 affected·Jun 1, 2018
High RiskFDA
Nakanishi Inc.
Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are int...
Medical Implants·2,419 affected·Jun 1, 2018
High RiskFDA
Icu Medical Inc
0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02
Injectable Drugs·941,496 affected·May 31, 2018
High RiskFDA
Icu Medical Inc
5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02
Injectable Drugs·267,288 affected·May 31, 2018
High RiskFDA
Icu Medical Inc
0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37
Injectable Drugs·1,247,200 affected·May 31, 2018
High RiskFDA
Icu Medical Inc
0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23
Injectable Drugs·525,984 affected·May 31, 2018
High RiskFDA
Icu Medical Inc
0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37
Injectable Drugs·88,960 affected·May 31, 2018
High RiskFDA
Guardian Pharmacy Services
Methylene Blue 10 mg/mL 1ml. Packaged in 1 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Drugs·95 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Da...
Drugs·2,400 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 10...
Drugs·4,900 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL syringes. Refridgerate. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr...
Drugs·442 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dal...
Drugs·100 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C D...
Drugs·5,000 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Da...
Drugs·100 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX ...
Drugs·40 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 10...
Drugs·20 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX...
Drugs·250 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dalla...
Drugs·60 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dall...
Drugs·100 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dall...
Drugs·20 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dalla...
Drugs·2,600 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dall...
Drugs·25 affected·May 17, 2018