Medical device recalls
39231 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-05-30FDA-DeviceSynthes (USA) Products LLCClass IISynthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.
The adapter may demonstrate a degradation of function as the final products were assembled with ball bearings of high carbon content that is likely to rust prematurely.
- 2018-05-30FDA-DevicePhilips Electronics North America Corp.Class IIPhilips HeartStart (HS1) Onsite/Home AED
An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.
- 2018-05-30FDA-DevicePhilips Electronics North America Corp.Class IIPhilips HeartStart FRx AED.
An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.
- 2018-05-30FDA-DeviceSpinal ElementsClass IIAMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Device is designed for use in intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. The ¿LIF features a self-locking expansion mechanism that is infinitely adjustable, along with a bullet nose design for minimal impaction and ease of insertion. The ¿LIF is strea
Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis.
- 2018-05-30FDA-DeviceBaxter Healthcare CorporationClass IIBaxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,
- 2018-05-30FDA-DeviceBaxter Healthcare CorporationClass IIBaxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,
- 2018-05-30FDA-DeviceBaxter Healthcare CorporationClass IIBaxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,
- 2018-05-30FDA-DeviceBaxter Healthcare CorporationClass IIBaxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,
- 2018-05-30FDA-DeviceSmith & Nephew, Inc.Class IIsmith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF 71453101designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
- 2018-05-30FDA-DeviceSmith & Nephew, Inc.Class IIsmith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
- 2018-05-30FDA-DeviceSmith & Nephew, Inc.Class IIsmith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
- 2018-05-30FDA-DeviceSmith & Nephew, Inc.Class IIsmith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
- 2018-05-30FDA-DeviceSmith & Nephew, Inc.Class IIsmith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. The constrained knee systems are designed for use in patients in primary and revis
A single lot of GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING due to a laser mark labeling error. The left valgus bushing was incorrectly laser marked as right and vice versa.
- 2018-05-30FDA-DeviceLivaNova USAClass IISorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz
Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Stockert Heater-Cooler System 3T devices are suspected of microbial contamination and may contain visible biofilm.
- 2018-05-30FDA-DeviceMadison Polymeric EngineeringClass IIDraco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent, Catologue Number HY0305Z
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
- 2018-05-30FDA-DeviceMadison Polymeric EngineeringClass IITravel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number TK-200(W)
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
- 2018-05-30FDA-DeviceMadison Polymeric EngineeringClass IIFirst Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
- 2018-05-30FDA-DeviceMadison Polymeric EngineeringClass IIFirst Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4B
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
- 2018-05-30FDA-DeviceMadison Polymeric EngineeringClass IIFirst Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
- 2018-05-30FDA-DeviceMadison Polymeric EngineeringClass IIFirst Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-3
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
- 2018-05-30FDA-DeviceBeckman Coulter Inc.Class IIiChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001. The iChemVELOCITY automated urine chemistry system is an in-vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in a iQ200 Series system, a configuration given the proprietary name iRICELL as it is de
The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity.
- 2018-05-23FDA-DeviceBeckman Coulter Inc.Class IIiChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips. The iChem VELOCITY can be used as a stand alone-system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quant
A subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry strips has an incorrect pad placed in the location of the leukocytes pad. This will result in control CB failure for leukocytes and may generate false negative erroneous results for leukocytes.
- 2018-05-23FDA-DeviceSouthmedic, Inc.Class IISouthmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.
Scalpels lot contains non-sterile products labeled as sterile.
- 2018-05-23FDA-DeviceVolcano CorporationClass IIPhilips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.
The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.
- 2018-05-23FDA-DeviceConvaTec, IncClass IIConvatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with Flexible Collar 22mm Precut Skin Barrier is used together with Esteem Synergy pouches as an ostomy system intended for the management of stomal output.
It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box label.
- 2018-05-23FDA-DeviceEthicon Endo-Surgery IncClass II5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST
Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
- 2018-05-23FDA-DeviceEthicon Endo-Surgery IncClass II5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT
Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
- 2018-05-23FDA-DeviceEthicon Endo-Surgery IncClass II5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT
Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
- 2018-05-23FDA-DeviceEthicon Endo-Surgery IncClass II5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2B5ST
Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
- 2018-05-23FDA-DeviceEthicon Endo-Surgery IncClass II5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT
Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
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