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
Trimed Inc.
Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
Medical Devices·532 affected·Apr 13, 2018
High RiskFDA
Trimed Inc.
Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f)...
Medical Devices·1,194 affected·Apr 13, 2018
High RiskFDA
Arrow International Inc
4Fr. Catheter Clamp with Fastener; Product Code: CC-00004
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
8Fr. Catheter Clamp with Fastener; Product Code: CC-00008
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Maximal Barrier Drape; Product Code: ASK-04000-HMC
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR...
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 ...
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Peel Away Sheath over Dilator; Product Codes: PL-05041 and PL-05052
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Maximal Barrier Drape; Product Codes: ASK-00001-1A
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703...
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Epidural Needle; Product Codes: AN-05501 and AN-05505
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
VPS Rhythm ECG Accessory Pack with Johans Adapter; Product codes: RHY-100-ECGJ
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Radial Arterial Access Kit; Product Code: ASK-04001-BID2
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit; Product Code: ASK-42802-PWHC1
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Arterial Catheterization Kit; Product Code:NA-04550-1A
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Extension Line Slide Clamps; Product codes: SA-09847
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: ASK-45703-VC
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-09903-UPA
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
PICC Catheter Trimmer ; Product Code:PC-00001-T
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM, PR-35052-HPHNM, PR-35541-HPHNL, PR-35541-HPHNM, PR-35552-H...
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
VPS Rhythm ECG Accessory Pack ; Product codes: RHY-100-ECGO
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
TheraCath(R) Epidural Catheter; Product Code: EC-05000
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
7Fr. Catheter Clamp with Fastener; Product Code: CC-00007
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Maximal Barrier Drape; Product Codes: ASK-00002-1A
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
5Fr. Catheter Clamp with Fastener; Product Code: CC-00005
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-42563-HPHNM
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr. Catheters; Product Code: ASK-21142-WHC2
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Percutaneous Sheath Introducer Kit with ARROWgard Blue¿ Sheath and Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheter...
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Arterial Catheterization Kit; Product Codes: ASK-04020-DH
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROWg+ard Blue PLUS¿ Pressure Injectable Two-Lumen CVC Kit; Product Code: CDC-42802-P1A
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Echogenic Introducer Needle; Product Code: AN-04318
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROWg+ard Blue¿ PSI Kit with Integral Hemostasis Valve/ Side Port for use with 7 - 7.5 Fr. Catheters; Product codes: SF-29803-1
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Clear Fenestrated Drape with Adhesive; Product Code: CD-00001
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROW PICC Set; Product codes: PR-35563-HPHNL and PR-35563-HPHNM
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS, PR-45041-BAS, PR-45052-BAS, PR-45063-BA...
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires; Product Code: AI-07000
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROWgard Blue PLUS¿ Multi-Lumen CVC Kit with Blue FlexTip¿ Catheter; Product Code: MSO-45703-AHS
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis Valve/Side Port for use with 7 - 8 Fr. Catheters and Arrow Perc...
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
0.2 Micron Flat Epidural Filter; Product Code: EF-05500
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Bard Brachytherapy, Inc.
BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-...
Medical Implants·70 affected·Apr 10, 2018
High RiskFDA
Orthofix, Inc
Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011C
Medical Devices·50 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001)
Medical Devices·36 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L); b) Right (003-E-00001R)
Medical Devices·30 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-009C
Medical Devices·100 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number): a) Small/0MM Step/Left (002-C-0...
Medical Devices·156 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020); b) Medium (002-G-01025); c) Lar...
Medical Devices·24 affected·Apr 6, 2018