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
Guardian Pharmacy Services
Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dall...
Drugs·3 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Da...
Drugs·60 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Da...
Drugs·300 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 1...
Drugs·2,000 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dalla...
Drugs·2 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Magnesium Sulfate 200 mg/mL, 100ml. Rx. Only. Packaged in 100 mL MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste....
Drugs·1,000 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 10...
Drugs·1 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Drugs·250 affected·May 17, 2018
High RiskFDA
Zimmer Biomet, Inc.
G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedull...
Medical Implants·832 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 NL DRIVING GUIDE 4.4MM X 80CM; 467220 Intended to be used as a guide pin for insertion of implant...
Medical Implants·11 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
3.2MM X 560MM COCR THD TIP; 14-441053 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramed...
Medical Implants·2,396 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intrame...
Medical Implants·1,234 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedull...
Medical Implants·248 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intr...
Medical Implants·449 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
DRILL PT GUIDE WIRE 2MM X 60CM; 469320 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intrame...
Medical Implants·34 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramed...
Medical Implants·2,168 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intrame...
Medical Implants·10 affected·May 16, 2018
High RiskFDA
Olsen Medical
Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument Connector, 12' (3.6m), REF 87500, QTY 50 (b) B...
Medical Devices·323,886 affected·May 11, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531
Medical Devices·17 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
5F DL BIOFLO PASV, Catalog Number 60M141006
Medical Devices·36 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
RS 5F DL BIOFLO PASV, Catalog Number 60M132324
Medical Devices·2 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810
Medical Devices·23 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
RS TANDEM 5F DL XPP, Catalog Number 60M019881
Medical Devices·7 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
5F DL BIOFLO PICC, Catalog Number 60M180592
Medical Devices·12 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire PG, Catalog Number 75-032
Medical Devices·3 affected·May 10, 2018
High RiskFDA
Life Technologies, Corp.
GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture medium.
Medical Devices·141 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
CAN 5F DUAL XCELA PICC, Catalog Number 60M701532
Medical Devices·27 affected·May 10, 2018
High RiskFDA
Life Technologies, Corp.
Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175. Tissue and cell culture medium.
Diabetes Devices·91 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582
Medical Devices·13 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
RS 5F DL BIOFLO PASV, Catalog Number 60M150373
Medical Devices·7 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003
Medical Devices·99 affected·May 10, 2018
High RiskFDA
Zimmer Dental Inc
Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Impla...
Medical Implants·299 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872
Medical Devices·20 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
RS 5F DL BIOFLO PASV, Catalog Number 60M181578
Medical Devices·11 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
RS 5F DL BIOFLO PICC, Catalog Number 60M071831
Medical Devices·12 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490
Medical Devices·190 affected·May 10, 2018
High RiskFDA
Smiths Medical Asd Inc.
medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-...
Medical Devices·933,518 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871
Medical Devices·200 affected·May 10, 2018
High RiskFDA
Life Technologies, Corp.
Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium.
Medical Devices·6 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124
Medical Devices·7 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882
Medical Devices·17 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887
Medical Devices·246 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
RS 5F DL XPP KIT, Catalog Number 60M183104
Medical Devices·5 affected·May 10, 2018
High RiskFDA
Rij Pharmaceutical Llc
Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle, Distributed by Geritrex, LLC 144 Kingsbridge Rd East Mt Ve...
Drugs·31,411 affected·May 7, 2018
High RiskFDA
Rij Pharmaceutical Llc
Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Magnesium Hydroxide 400mg, Simethicone 40 mg), packaged in 12 F...
Drugs·5,043 affected·May 7, 2018
High RiskFDA
Rij Pharmaceutical Llc
RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, packaged in 4 FL. OZ. (118 mL), RIJ PHARMACETUICAL CORPORATION, 40 COMMERCIAL A...
Drugs·1,272 affected·May 7, 2018
High RiskFDA
Rij Pharmaceutical Llc
Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL, packaged in 16 FL OZ (473 mL), Dist. By Gericare Pharmaceuticals 1650 ...
Drugs·13,380 affected·May 7, 2018
High RiskFDA
Rij Pharmaceutical Llc
RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ Pharmaceuticals Corporation 40 Commercial Avenue, Middlet...
Drugs·1,505 affected·May 7, 2018