March 2016 recalls

772 recalls were announced in March 2016.

What the numbers show

Critical: 29
Severe: 169
High: 353
Moderate: 197
Low: 24

Of the 772 recalls this month scored against our rubric, 4% are Critical, 22% are Severe.

Which agencies issued them

701–772 of 772

HighFDA (Devices)·Z-0962-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, causing leakage.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: MM00548410 (XMD P/N 70-0050-814) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The En
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0634-2016·2016-03-02
Fresh Express Chopped Romaine Lettuce Recalled for Undeclared Allergens
Fresh Express is recalling Club Size Chopped Romaine Lettuce because it contains undeclared milk, eggs, wheat, and fish.
Product
Fresh Express, Club Size, Chopped Romaine Lettuce, 32 oz., in clear flexible plastic bags, containing condiments in a separate clear flexible plastic bag.
Category
Food
Distribution
4 states
HighFDA (Devices)·Z-0931-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
Xeridiem is recalling 32 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549330 (XMD P/N 70-0050-322) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0625-2016·2016-03-02
Great Pacific Bagel & Cream Cheese Recalled for Undeclared Wheat
Vern's & Son Food Service Distributing is recalling Great Pacific Bagel & Cream Cheese due to undeclared wheat. The product was distributed in Oregon and Washington.
Product
Great Pacific Bagel & Cream Cheese, product is wrapped with flexible clear plastic, net weight 4.5 oz. The UPC is UPC 92438 00300
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-0932-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 37 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, causing leakage of feeding solution or gastric contents.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549470 (XMD P/N 70-0050-324) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0973-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc. is recalling 34 EndoVive 3s Low Profile Balloon Kits due to a feeding valve leakage issue that may allow gastric contents to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549530 (XMD P/N 70-0050-924) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0857-2016·2016-03-02
Philips PIIC Classic Upgrade Patient Monitor Recall for ECG Waveform Misrepresentation
Philips is recalling PIIC Classic Upgrade patient monitors because reconstructed ECG leads may misrepresent waveforms on the Information Center iX.
Product
Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0858-2016·2016-03-02
Philips IntelliVue Info Center iX Recalled for ECG Waveform Misrepresentation
Philips is recalling IntelliVue Info Center iX monitors because reconstructed ECG leads may misrepresent waveforms, potentially affecting clinical interpretation.
Product
Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0829-2016·2016-03-02
Cardiac Science Defibrillation Electrodes Recalled for Impedance Issues
Cardiac Science is recalling specific defibrillation electrodes that may develop high electrical impedance, causing AED self-test failures.
Product
9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AE
Category
Medical Device
Distribution
3 states
ModerateFDA (Food)·F-0623-2016·2016-03-02
Purple Cow Cookie Butter Ice Cream Recalled for Mislabeling
House of Flavors is recalling Purple Cow Limited Edition Cookie Butter Ice Cream because the cups contain Butter Pecan ice cream instead.
Product
Purple Cow Limited Edition Cookie Butter Ice Cream, 8 oz. cups, packed in paper cartons
Category
Food
Distribution
6 states
ModerateFDA (Devices)·Z-0828-2016·2016-03-02
Stryker Aero-AL Impaction Handle Recalled for Jamming Defect
Stryker Spine is recalling 31 Aero-AL Impaction Handles due to reported jamming when assembled to the Inserter guide.
Product
Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion of the Aero-AL cage into the disc space.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0846-2016·2016-03-02
Zimmer Biomet Recalls Versus 6 Inch Beaded FC 1 Hip Prosthesis
Zimmer Biomet is recalling 130 units of Versus 6 Inch Beaded FC 1 hip prostheses because the packaging bag adheres to the implant surface.
Product
VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascula
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0622-2016·2016-03-02
Jody's Gourmet Popcorn Recalls Fudge Chocolate Walnut Fudge Due to Mold
Jody's Gourmet Popcorn is recalling Fabulous Fudge Chocolate Walnut fudge because consumers reported mold on the product before its expiration date.
Product
Jody's Gourmet Popcorn, Fabulous Fudge Chocolate Walnut, net weight 8 oz. , one unit per package, packed in clear clamshell, expiration date 12/22/15
Category
Food
Distribution
0 states
ModerateFDA (Devices)·Z-0843-2016·2016-03-02
Zimmer Biomet Recalls CPT Hip Prostheses Due to Packaging Adhesion
Zimmer Biomet is recalling 289 CPT 12/14 COCR hip prostheses because the LDPE packaging bag adheres to the implant surface.
Product
CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, poly
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0879-2016·2016-03-02
Stryker T2 Guidewire Recalled Due to Potential Pouch Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because the packaging seal integrity may be decreased, potentially affecting the sterile barrier.
Product
Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0725-2016·2016-03-02
Zydus Recalls Risperidone Tablets Due to Impurity Failure
Zydus Pharmaceuticals is recalling 9,504 bottles of 2 mg risperidone tablets because they failed impurity specifications. The affected lot is MP4967.
Product
risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0885-2016·2016-03-02
Biomet Recalls HipLOC CHS Plate/Lag Screw Introducer Due to Sizing Defect
Biomet is recalling 23 HipLOC CHS Plate/Lag Screw Introducers because some units are undersized and fail to accept the coupling screw.
Product
HipLOC CHS Plate/Lag Screw Introducer
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-0887-2016·2016-03-02
Fresenius Naturalyte Liquid Acid Concentrate Recalled for Labeling Error
Fresenius Medical Care is recalling Naturalyte Liquid Acid Concentrate because the label incorrectly lists the calcium concentration.
Product
Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0803-2016·2016-03-02
Olympus Delta XRF Analyzer Recalled Due to Software Bug
Olympus Scientific Solutions Americas is recalling Delta XRF Analyzers because the firm discovered a software bug.
Product
Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0850-2016·2016-03-02
Zimmer Biomet Recalls Metasul Head 40 Total Hip Prosthesis Components
Zimmer Biomet is recalling 194 Metasul Head 40 total hip prosthesis components because the packaging bag adheres to the implant surface.
Product
Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noninflammatory degenerative joint disease (NIDJD) including avascular necrosis, osteoarthritis, post-traumatic arthritis and congenital hip dysplasia and inflammatory joint disease (IJD) e.g. rheumatoid
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0698-2016·2016-03-02
Bigwall WARM STEAM Personal Steam Inhaler Recalled for Unconfirmed Consumer Complaints
Bigwall Enterprises is recalling WARM STEAM Personal Steam Inhalers nationwide due to unconfirmed consumer complaints. No causal link to product use has been established.
Product
WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & nasal masks" Product labeling reads in part: "Well at Walgreens***WARM Helps relieve symptoms of stuffy nasal passages, congestion or scratchy throats due to cold, flu or allergi
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0875-2016·2016-03-02
Stryker T2 Guidewire Recalled Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0841-2016·2016-03-02
Zimmer Biomet Recalls NexGen LPS Flex Femoral Knee Implants
Zimmer Biomet is recalling NexGen LPS Flex femoral knee implants because the packaging bag adheres to the polished implant surface.
Product
NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, os
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0876-2016·2016-03-02
Stryker T2 Guidewire Recalled Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0838-2016·2016-03-02
Zimmer Biomet Recalls Knee Implants Due to Packaging Adhesion Defect
Zimmer Biomet is recalling specific CR Flex and Natural Knee prosthesis components because the LDPE packaging bag adheres to the polished implant surface.
Product
CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Flex Natural Knee GSM POR Flex prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Components with CSTi porous coating are indi
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0883-2016·2016-03-02
Stryker T2 K-Wire Recall Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0855-2016·2016-03-02
Stryker Vitallium Wire Recalled Due to Sterilization Labeling Error
Stryker is recalling Vitallium Wire because the instructions incorrectly state the non-sterile device is sterile, omitting required sterilization steps.
Product
Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0871-2016·2016-03-02
Stryker Gamma Guide Pin Recalled for Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling Gamma Guide Pins because a packaging review indicated that the seal integrity of the pouch may be decreased.
Product
Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0872-2016·2016-03-02
Stryker Gamma3 K-Wire Recall Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling Gamma3 K-Wires because the packaging seal integrity may be decreased, potentially affecting the sterile barrier.
Product
Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0862-2016·2016-03-02
Siemens Recalls Syngo Plaza PACS Software Due to Display and Access Issues
Siemens is recalling 68 units of Syngo Plaza PACS software to fix bugs affecting image display, saving, and access controls.
Product
Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology informat
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0839-2016·2016-03-02
Zimmer Biomet Recalls Natural-Knee II Femoral Prostheses Due to Packaging Defect
Zimmer Biomet is recalling 13,483 Natural-Knee II femoral prostheses because the LDPE packaging bag adheres to the polished implant surface.
Product
NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer variou sizes Product Usage "" The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating is indicated for uncemented or
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0874-2016·2016-03-02
Stryker T2 K-Wire Recall Due to Potential Packaging Seal Integrity Issues
Stryker is recalling T2 K-Wires because the packaging seal integrity may be decreased, potentially affecting the sterility of the medical devices.
Product
Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0842-2016·2016-03-02
Zimmer Biomet Recalls Knee Implants Due to Packaging Adhesion Defect
Zimmer Biomet is recalling 4,567 knee prosthesis units because the LDPE packaging bag adheres to the polished implant surface.
Product
PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthriti
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0627-2016·2016-03-02
Frozen Kingfish Steaks Recalled for Decomposition and Misidentification
President East Company is recalling frozen kingfish steaks because FDA analysis found the product was decomposed and actually Spanish mackerel.
Product
FROZEN KINGFISH STEAK, QF, IVP, Size: 10/12 OZ, WEIGHT 22 LBS, IMPORTER:PRESIDENT EAST COMPANY, PRODUCT OF TAIWAN, individual pieces are held within clear plastic vacuum-sealed packaging.
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-0869-2016·2016-03-02
Stryker Gamma K-Wire Recall Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling Gamma K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0836-2016·2016-03-02
Zimmer Biomet Recalls Knee Prosthesis Due to Packaging Adhesion Issue
Zimmer Biomet is recalling Zimmer Uni High Flex Precoat Femoral knee prostheses because the LDPE packaging bag adheres to the implant surface.
Product
ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various sizes These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyl
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0863-2016·2016-03-02
Hospira Symbiq Infusion Pumps Recalled for Missing Rubber Stop Pad
Hospira is recalling 6,634 Symbiq infusion pumps because the pole clamp assemblies may be missing a rubber stop pad. The devices were distributed to healthcare facilities in the U.S. and Canada.
Product
The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. It is intended primarily for use in the hospital setting and can be used in other acute and non-acute areas, such as, but not limited to, Nursing Homes, Mobi
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0864-2016·2016-03-02
EKOS EkoSonic Endovascular System Recalled for Incorrect Working Length Labeling
EKOS Corporation is recalling 10 units of the EkoSonic Endovascular System because the device is labeled with a 135 cm working length, but the actual working length is 106 cm.
Product
EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and removable MicroSonic Device (MSD), and a reusable EKOS EkoSonic Contro
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0848-2016·2016-03-02
Zimmer Biomet Recalls Versus Hip Prostheses Due to Packaging Adhesion
Zimmer Biomet is recalling 1,305 Versus 6-inch hip prostheses because the LDPE packaging bag adheres to the polished implant surface.
Product
VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascula
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0835-2016·2016-03-02
Zimmer Biomet Recalls NexGen Knee Implants Due to Packaging Adhesion Issue
Zimmer Biomet is recalling NexGen Knee femoral prostheses because the LDPE packaging bag adheres to the polished implant surface.
Product
NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee LPS Porous Fem NexGen Knee LPS Precoat Fem prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes This device is indicated for patient
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0847-2016·2016-03-02
Zimmer Biomet Recalls Versys Hip Prostheses Due to Packaging Adhesion
Zimmer Biomet is recalling 101 Versus 7.5 inch hip prostheses because the LDPE packaging bag adheres to the implant surface.
Product
VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascula
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0865-2016·2016-03-02
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Incorrect Packaging
Cook Inc. is recalling 25 Flexor Check-Flo Introducers because some packages labeled as 6.0Fr actually contained 5.0Fr devices.
Product
Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-0849-2016·2016-03-02
Zimmer Biomet Recalls Versys Hip Prostheses Due to Packaging Adhesion
Zimmer Biomet is recalling 4,844 Versys hip prostheses because the LDPE packaging bag adheres to the polished implant surface.
Product
VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INCH BEADED FC 2 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthriti
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0884-2016·2016-03-02
Stryker T2 K-Wire Recall Due to Potential Pouch Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0823-2016·2016-03-02
Leica Bond Polymer Refine Detection System Recalled for Inadequate Staining
Leica Microsystems is recalling the Bond Polymer Refine Detection System because it may not provide adequate staining when used with specific protocols.
Product
This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.
Category
Medical Device
Distribution
37 states
ModerateFDA (Devices)·Z-0753-2016·2016-03-02
GE Precision MPi X-ray System Recalled for Touch Panel Boot Issues
Regulatory Insight, Inc. is recalling 43 GE Precision MPi X-ray systems because the Remote Touch Panel may fail to boot up as intended.
Product
GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-0882-2016·2016-03-02
Stryker T2 Fixation K-Wire Recall Due to Packaging Seal Integrity Concerns
Stryker Howmedica Osteonics Corp. is recalling T2 Fixation K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0844-2016·2016-03-02
Zimmer Biomet Recalls CPT Hip Prostheses Due to Packaging Adhesion Issue
Zimmer Biomet is recalling CPT 12/14 COCR hip prostheses because the LDPE packaging bag adheres to the polished implant surface.
Product
CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes "The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, pol
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0830-2016·2016-03-02
Zimmer Biomet Recalls LPS-FLEX GSF OPT Knee Prostheses Due to Packaging Defect
Zimmer Biomet is recalling LPS-FLEX GSF OPT knee prostheses because the LDPE bag adheres to the implant surface. The recall covers 84,396 units distributed worldwide.
Product
LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Various sizes¿ Product Usage "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthr
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0845-2016·2016-03-02
Zimmer Biomet Recalls Bipolar Shell Hip Prostheses Due to Packaging Defect
Zimmer Biomet is recalling 72,806 Bipolar Shell hip prostheses because the LDPE packaging bag adheres to the polished implant surface.
Product
Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented various sizes Use of the MultiPolar Bipolar Cup is indicated in: Fracture dislocation of the hip. Elderly, debilitated patients when a total hip replacement is contra
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0832-2016·2016-03-02
Zimmer Biomet Recalls NexGen LPS-FLEX Femoral Knee Implants
Zimmer Biomet is recalling NexGen LPS-FLEX femoral knee implants because the packaging bag adheres to the polished implant surface.
Product
NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Product Usage "" This device is indicated for patients with severe knee pain and disability due to: Rheumato
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0873-2016·2016-03-02
Stryker T2 K-Wire Recalled Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0878-2016·2016-03-02
Stryker T2 Guidewire Recalled for Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0859-2016·2016-03-02
Medtronic Spinal Cord Stimulation Leads Recalled for Labeling Deficiencies
Medtronic is recalling Specify 5-6-5 and 2x8 spinal cord stimulation leads because the labeling does not adequately distinguish between permanent implant and trialing use.
Product
Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for treating chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0880-2016·2016-03-02
Stryker T2 Guidewire Recalled Due to Potential Packaging Seal Integrity Issues
Stryker is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased, potentially affecting sterility.
Product
Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0870-2016·2016-03-02
Stryker Gamma K-Wire Recall Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling Gamma K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1018-2016·2016-03-02
Sorin Group Recalls CDI H/S Cuvettes Due to Connection Error
Sorin Group USA is recalling CDI H/S Cuvettes because they may fail to connect properly with the probe, causing the monitor to display an error and preventing blood parameter values from displaying.
Product
CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surger
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0834-2016·2016-03-02
Zimmer Biomet Recalls NexGen Knee Implants Due to Packaging Adhesion
Zimmer Biomet is recalling NexGen Knee LPS and Lock femoral components because the LDPE packaging bag adheres to the polished implant surface.
Product
NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Product Usage "" This device is indicated for patients with severe knee pain and disability due t
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0831-2016·2016-03-02
Zimmer Biomet Recalls NexGen CR-FLEX Knee Implants Due to Packaging Defect
Zimmer Biomet is recalling NexGen CR-FLEX knee prostheses because the LDPE packaging bag adheres to the implant surface. The recall covers 42,064 units distributed worldwide.
Product
NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes "" This device is indicated for patients with severe knee pain and disability due to: Rheum
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0837-2016·2016-03-02
Zimmer Biomet Recalls Gender PFJ Femoral Components Due to Packaging Defect
Zimmer Biomet is recalling 5,103 Gender PFJ Femoral Components because the LDPE packaging bag adheres to the implant surface. The device is distributed worldwide.
Product
Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes " Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The salvage
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0881-2016·2016-03-02
Stryker T2 Guidewire Recalled for Potential Pouch Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0877-2016·2016-03-02
Stryker T2 Guidewire Recalled Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review indicated that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0833-2016·2016-03-02
Zimmer Biomet Recalls NexGen Knee Implants Due to Packaging Adhesion
Zimmer Biomet is recalling NexGen Knee CR femoral components because the packaging bag adheres to the implant surface.
Product
NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthr
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0851-2016·2016-03-02
BD FMC7 FITC Recalled for Incorrect Expiration Date Labeling
Becton, Dickinson and Company is recalling 78 units of BD FMC7 FITC reagent because the vial labels display an incorrect expiration date.
Product
BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen. Product Usage: Analyte Specific Reagent. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0727-2016·2016-03-02
Hospira Recalls Normosol-M Bags With Incorrect Expiration Date Labeling
Hospira is recalling 10,778 bags of Normosol-M and 5% Dextrose Injection due to an incorrect expiration date printed on the primary container.
Product
Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7965-09, Barcode (01) 0 030409 796509 0.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0840-2016·2016-03-02
Zimmer Biomet Recalls Knee Implants Due to Packaging Adhesion Issue
Zimmer Biomet is recalling CR Flex and LPS Flex knee prostheses because the LDPE packaging bag adheres to the polished implant surface.
Product
CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femoral prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes This device is indicated for patients with severe knee pain and disability
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0728-2016·2016-03-02
Isomeric Pharmacy Recalls Triamcinolone Diacetate Injectable Suspension Due to Labeling Errors
Isomeric Pharmacy Solution, LLC is recalling 114 vials of Triamcinolone Diacetate Injectable Suspension because some vials may have incorrect lot numbers or expiration dates.
Product
Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial for Injection, Rx only, Isomeric Pharmacy Solutions, 2401 Foothill Dr., Salt Lake City, UT 84109
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·16V122000·2016-03-01
Maserati Recalls Ghibli and Quattroporte Due to Floor Mat Defect
Maserati is recalling 2014-2016 Ghibli and Quattroporte vehicles because the driver-side floor mat anchor may break, allowing the mat to trap the accelerator pedal.
Product
MASERATI — MASERATI GHIBLI, QUATTROPORTE
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·16111·2016-03-01
United Pet Group Recalls Top Fin Aquarium Power Filters for Shock Hazard
United Pet Group is recalling Top Fin power filters for aquariums because a conductor can expose consumers to electric shock. No injuries have been reported.
Product
Top Fin™ Power Filters for Aquariums
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·16V121000·2016-03-01
Freightliner Custom Chassis XCP Recalled for Power Steering Hose Failure Risk
Daimler Trucks North America is recalling 2014-2016 Freightliner Custom Chassis XCP vehicles because power steering hoses may fail due to high fluid temperatures, increasing crash risk.
Product
FCCC — FCCC XCP
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·16110·2016-03-01
Ambient Weather Radios Recalled Due to Fire Hazard
Ambient Weather is recalling about 57,000 radios that can overheat when plugged into AC power, posing a fire hazard.
Product
Ambient Weather radios
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·16E016000·2016-03-01
Carquest DOT5 Silicone Brake Fluid Recalled for Labeling Defects
American Grease Stick Company is recalling Carquest DOT5 Silicone Brake Fluid bottles manufactured between October 2013 and September 2015 due to missing or unclear labeling required by federal safety standards.
Product
SERVICE BRAKES, HYDRAULIC:FLUID recall
Category
Vehicle
Distribution
Distributed nationwide

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