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
Intrathecal Compounding Specialist, Llc
All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between October 16, 2017 and No...
Drugs·0 affected·Nov 30, 2017
High RiskFDA
Intrathecal Compounding Specialist, Llc
All sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF Base Solution dispensed between October 16, 2017 ...
Drugs·0 affected·Nov 30, 2017
High RiskFDA
Intrathecal Compounding Specialist, Llc
All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 an...
Drugs·0 affected·Nov 30, 2017
High RiskFDA
Intrathecal Compounding Specialist, Llc
All sterile drug preparations remaining within expiry prepared from Sufentanil Citrate Base Solution dispensed between October 16, 2017 ...
Drugs·0 affected·Nov 30, 2017
High RiskFDA
Smith & Nephew, Inc.
smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (1...
Medical Devices·12 affected·Nov 29, 2017
RecallFDA
Ecolab Inc
ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/...
Surgical Devices·65 affected·Nov 22, 2017
RecallFDA
Ecolab Inc
ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons...
Surgical Devices·65 affected·Nov 22, 2017
High RiskFDA
Omnilife Science Inc.
Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a primary or revisio...
Medical Implants·32 affected·Nov 20, 2017
High RiskFDA
Stryker Corporation
STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
Medical Devices·60,753 affected·Nov 17, 2017
High RiskFDA
Stryker Corporation
STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600);...
Medical Devices·60,753 affected·Nov 17, 2017
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
Injectable Drugs·25,356 affected·Nov 13, 2017
CriticalFDA
Baxter Healthcare Corporation
Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. ...
Injectable Drugs·35,628 affected·Nov 10, 2017
High RiskFDA
Zevex Incorporated (dba Moog Medical Medical Devices Group)
MOOG Curlin Infusion Administration Set, Ref 340-4133, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Needleless Injection Port ...
Medical Devices·756 affected·Nov 10, 2017
High RiskFDA
Zevex Incorporated (dba Moog Medical Medical Devices Group)
MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Y-Site with Check Valve, p...
Medical Devices·2,497 affected·Nov 10, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for orthopedic use.
Medical Devices·732 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.
Medical Devices·320 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.
Medical Devices·12 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.
Medical Devices·900 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use.
Medical Devices·51 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-...
Medical Devices·504 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 ...
Medical Devices·1,542 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurize...
Medical Devices·444 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for orthopedic use.
Medical Devices·384 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-0...
Medical Devices·1,244 affected·Nov 9, 2017
High RiskFDA
Owen Mumford Usa, Inc.
Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use p...
Medical Devices·2,660 affected·Nov 6, 2017
High RiskFDA
Owen Mumford Usa, Inc.
Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use p...
Medical Devices·708 affected·Nov 6, 2017
High RiskFDA
Alden Optical
NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Usage: The NOVAKONE TORIC lens is indicated for daily wear fo...
Medical Devices·33 affected·Nov 3, 2017
High RiskFDA
Alden Optical
Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 Product Usage: The ALDEN SPHERE LENS for daily wear is indic...
Medical Devices·4 affected·Nov 3, 2017
High RiskFDA
Alden Optical
NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The NOVAKONE SPHERICAL lens is indicated for daily wear for ...
Medical Devices·3 affected·Nov 3, 2017
High RiskFDA
Alden Optical
Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for...
Medical Devices·5 affected·Nov 3, 2017
High RiskFDA
Alden Optical
Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for...
Medical Devices·56 affected·Nov 3, 2017
High RiskFDA
Pro-med Instruments Gmbh
pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY...
Medical Devices·1,142 affected·Nov 2, 2017
RecallFDA
Xintec Corp
OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Ste...
Medical Devices·45 affected·Oct 29, 2017
High RiskFDA
Howmedica Osteonics Corp.
radial stem implant #3 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radia...
Medical Implants·750 affected·Oct 24, 2017
High RiskFDA
Howmedica Osteonics Corp.
#4 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHe...
Medical Implants·546 affected·Oct 24, 2017
High RiskFDA
Howmedica Osteonics Corp.
radial stem implant #1 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radia...
Medical Implants·256 affected·Oct 24, 2017
High RiskFDA
Howmedica Osteonics Corp.
#2 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radi...
Medical Implants·543 affected·Oct 24, 2017
High RiskFDA
Howmedica Osteonics Corp.
#1 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radi...
Medical Implants·169 affected·Oct 24, 2017
High RiskFDA
Howmedica Osteonics Corp.
#3 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radi...
Medical Implants·673 affected·Oct 24, 2017
High RiskFDA
Medtronic Minimally Invasive Therapies Group
Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension for different types of de...
Medical Devices·58,954 affected·Oct 24, 2017
High RiskFDA
Howmedica Osteonics Corp.
radial stem implant #2 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radia...
Medical Implants·544 affected·Oct 24, 2017
High RiskFDA
Howmedica Osteonics Corp.
#4 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radi...
Medical Implants·387 affected·Oct 24, 2017
High RiskFDA
Howmedica Osteonics Corp.
#3 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHe...
Medical Implants·999 affected·Oct 24, 2017
High RiskFDA
Howmedica Osteonics Corp.
#2 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHe...
Medical Implants·605 affected·Oct 24, 2017
High RiskFDA
Howmedica Osteonics Corp.
radial head implant #4 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radia...
Medical Implants·628 affected·Oct 24, 2017
High RiskFDA
Medline Industries Inc
Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glove.
Surgical Devices·8,000 affected·Oct 23, 2017
High RiskFDA
Terumo Bct, Inc.
HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that ta...
Medical Devices·525 affected·Oct 20, 2017
High RiskFDA
Terumo Bct, Inc.
HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
Medical Devices·30 affected·Oct 20, 2017