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
Zimmer Manufacturing B.v.
Product 52 consists of product code: HWC and same usage: Item no: 525004530 NEXGEN OSTEOTOMY CORT BON 525004540 NEXGEN OSTEOTOMY CORT...
Medical Devices·925 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 28 consists of all product under product code: JDI and same usage: Item no: 32902605000 FEMORAL HD 28MM MEDIUM 32902604000 FE...
Medical Devices·0 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 51 consists of all product under product code: JWH and same usage: Item no: 598603701 NEXGEN OPTION STEMMED TIB 598603702 NE...
Medical Devices·29,525 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 36 consists of all product under product code: HSB and same usage: Item no: 225302745 INTERLOCKING IM SCREW 4.5 225303045 IN...
Medical Implants·268 affected·Jan 11, 2016
High RiskFDA
Arthrex, Inc.
Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture ...
Medical Implants·117 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 17 consists of all product under product code: LPH and same usage: Item no: 625004515 BONE SCREW 4.5X15 SELF-TA 625004520 B...
Medical Devices·87,341 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 45 consists of all product under product code: JWH and same usage: Item no: 511007020 MGII KNEE SLF-TAP BONE ST 511007025 MG...
Medical Devices·3,696 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 34 consists of all product under product code: JWH and same usage: Item no: 522001700 I/B II KNEE DOMED PATELLA 522001800 I/...
Medical Devices·512 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 59 consists of all product under product code: JWH and same usage: Item no: 42540000026 PSN ALL POLY PAT PLY 26MM 42540000029...
Medical Devices·112,588 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 14 consists of all product under product code HSB , and same usage: Item no: 225600230 ASIA ONE-PIECE LAG SCREW 225600232 A...
Medical Implants·0 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 62 consists of all product under product code: LPH and same usage: Item no: 620003620 TRILOGY ACET SHELL 36MM OD MULTI For ...
Medical Devices·400 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 19 consists of all product code: JDI and same usage: Item no: 765301101 CEM FEM ST 11X120 NOCOAT 765301201 CEM FEM ST 12X125 ...
Medical Devices·0 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 for use i...
Medical Devices·49 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 67 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERS...
Medical Devices·5,013 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 54 consists of all product under product code: JWH and same usage: Item no: 596009900 NEXGEN TAPER PLUG for use in total knee...
Medical Devices·1,767 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 64 consists of all product under product code: JDI and same usage: Item no: 902605101 UNIPOLAR ENDO FEM HEAD 51MM For use i...
Medical Devices·0 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 37 consists of all product under product code: HSB and same usage: Item no: 225302055 INTERLOCKING IM SCREW LG 225303055 INT...
Medical Implants·1,777 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 27 consists of all product under product code: HSB and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DI...
Medical Implants·945 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 3 consists of all products under product code JDI, and same usage: Item no:781803800 12/14 UNIPOLAR FEMORAL HE 781804000 12/14 ...
Medical Devices·2,239 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 15 consists of all product code JDI , and same usage: Item no: 805002802 ASTEL FEM HEAD +0X28MM DI 805002805 ASTEL FEM HEAD ...
Medical Devices·0 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 42 consists of all product under product code: HSB and same usage: Item no: 225224010 M/DN FEM IM NAIL 10MM DIA 225228010 M/...
Medical Devices·1,622 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 43 consists of all product under product code: HSB and same usage: Item no: 224001016 M/DN R-F IM NAIL 10MM DIA 224001018 M/...
Medical Devices·1,102 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 16 consists of all product under poduct code: KWY and same usage: Item no: 500103822 BIPOLAR LINER 38MM OD X 2 500103922 BIP...
Medical Devices·8,773 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 69 consists of all product under product code: JDI and same usage: Item no: 785301701 VERSYS CEMENTED FEM STEM 785301521 VERS...
Medical Devices·13 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 60 consists of all product under product code: HSB and same usage: Item no: 225207055 RECON SCREW LG 5.5MM DIA 225207555 RECO...
Medical Implants·1,394 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 63 consists of all product under product code: LPH and same usage: Item no: 620004020 TRILOGY ACET SHELL 40MM O 620004220 TRI...
Medical Devices·2,063 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 70 consists of all product under product code: JDI and same usage: Item no: 785701000 VERSYS HERITAGE FEM STEM 785701100 VERS...
Medical Devices·360 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 66 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERS...
Medical Devices·4,353 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 22 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 C...
Medical Devices·16 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 71 consists of all product under product code: JDI and same usage: Item no: 783401000 VERSYS PRESS FIT LD/FX ST 783401100 VER...
Medical Devices·2,388 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 40 consists of all product under product code: HSB and same usage: Item no: 225706565 ITST ANTI-ROTATION SCREW 225707065 ITS...
Medical Implants·7 affected·Jan 11, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to perform surgical procedures and patient care procedures s...
Surgical Devices·96 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9002615 EXTREMITY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such...
Surgical Devices·136 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9001482 ENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as w...
Surgical Devices·70 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT Used by medical staff to perform surgical procedures and ...
Surgical Devices·2,800 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT Used by medical staff to perform surgical procedures and patient care procedur...
Surgical Devices·40 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900582 UTILITY DRAPE WITH TAPE, SMS Used by medical staff to perform surgical procedures and patient care procedures ...
Surgical Devices·800 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900946 STRABISMUS SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such...
Surgical Devices·8 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9002830 ORTHOPEDIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures suc...
Surgical Devices·85 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900921A C-SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such...
Surgical Devices·238 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9001538 DRESSING CHANGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as...
Surgical Devices·550 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900036 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such...
Surgical Devices·132 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE Used by medical staff to perform surgic...
Surgical Devices·1,148 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900576A LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care proc...
Surgical Devices·144 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK
Surgical Devices·60 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9002618 OPEN HEART SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures su...
Cardiac Devices·47 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 900345 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as w...
Surgical Devices·55 affected·Jan 7, 2016
High RiskFDA
Customed, Inc
Catalog Number: 9002726 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care...
Surgical Devices·24 affected·Jan 7, 2016