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Medical device recalls

Medical device recalls from FDA, newest first.
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5 recalls

Intuitive Surgical da Vinci S, Si Tenaculum Forceps and Permanent Cautery Hook Instruments

The da Vinci S, Si Tenaculum Forceps Instrument has frayed or broken pitch cables.

Moderate risk, FDA, Device defect

Summa Therapeutics Finesse BTK Multicath Injectable Angioplasty Balloon Catheter

The injectable angioplasty balloon catheter may not meet burst specifications.

Moderate risk, FDA, Device defect

10 recalls

Mentor Breast Tissue Expanders

Artoura Breast Tissue Expanders may have infusion sets with dull or blunt needle tips that may be difficult to advance and/or break.

Moderate risk, FDA, Device defect

Philips Allura Xper and Azurion Angiography Systems

Philips Allura Xper and Azurion systems may not initiate X-ray imaging or may do so intermittently when using the wired foot switch.

Moderate risk, FDA, Device defect

BD Kiestra ReadA

The BD Kiestra ReadA can have modules unreachable after a reboot, delaying plate retrieval.

Moderate risk, FDA, Device defect

Medline Enfit g-Tube Connector

The ENFIT G-TUBE CONNECTOR may not seal properly, leading to leakage that could cause delayed care and fluid loss.

Moderate risk, FDA, Device defect

Ultradent Jiffy Original Composite Polisher Cups

Jiffy Original Composite Polisher Cups may crumble and break apart easily, which could cause a delay in patient treatment.

Moderate risk, FDA, Device defect

RefleXion X1 Radiotherapy System

The RefleXion X1 Radiotherapy System has a software defect that can deliver the treatment dose to an incorrect location.

Moderate risk, FDA, Software defect

Stryker CHROMOPHARE Softlit Ring Surgical Light System

The surgical light system may not adequately support the weight of the ceiling cover.

Moderate risk, FDA, Device defect

Philips Vue Motion V12

Vue Motion V12 may display image frames out of sequence during dynamic cine runs.

Moderate risk, FDA, Device defect

Puracol and Puracol Plus Collagen Wound Dressings

Puracol and Puracol Plus Collagen Wound Dressings have elevated endotoxin levels that may cause strong inflammatory response.

Moderate risk, FDA, Contamination

Atellica CH Enzymatic Hemoglobin A1c (A1c_E)

Atellica CH Enzymatic Hemoglobin A1c (A1c_E) may show depressed results when used with RCRP on the same analyzer, potentially delaying diabetes diagnosis.

Moderate risk, FDA, Device defect

3 recalls

Philips Respironics Trilogy Evo Ventilators

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

High risk, FDA, Device defect

Merit Medical Hemodialysis Catheters and Sheath Introducer

Hemodialysis catheters and a sheath introducer may not split as intended.

High risk, FDA, Device defect

BD Alaris System with Guardrails Suite MX with Point of Care Unit

The BD Alaris System with Guardrails Suite MX with Point of Care Unit lacks labeling for secure Wi-Fi communication.

Moderate risk, FDA, Labeling error

1 recall

Olympus Cutting Forceps

The cutting forceps have defective welds that can cause the jaw to break during use.

Moderate risk, FDA, Device defect

3 recalls

Medtronic MiniMed 780G Insulin Pumps

The MiniMed 780G insulin pump with software versions 6.60 and 6.61 has software defects that could cause hypoglycemia or hyperglycemia.

Moderate risk, FDA, Software defect

TECNIS Eyhance IOL with TECNIS Simplicity Delivery System

The TECNIS Eyhance IOL may have a haptic that sticks to the optic, preventing consistent unfolding.

Moderate risk, FDA, Device defect

Philips Ultrasound Transducers

Philips ultrasound transducers lack labelling to define their useful life.

Low risk, FDA, Labeling error

5 recalls

I.T.S. Orthopedic Plates and Screws

Volar Radius Plate with Angular Stability may cause higher temperature increases under certain MRI conditions.

Moderate risk, FDA, Device defect

Erbe Flexible Cryoprobes

Flexible Cryoprobes may rupture or burst during activation.

High risk, FDA, Device defect

Olympus Endoscope Valves and Reprocessors

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

Moderate risk, FDA, Device defect

GE Medical Systems Imactis CT-Navigation Systems

There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.

Moderate risk, FDA, Device defect

Beckman Coulter MicroScan Neg MIC 56 Panels

MicroScan panels may be contaminated in some wells.

Moderate risk, FDA, Contamination

4 recalls

Leksell Gamma Knife

The Leksell Gamma Knife has an adapter that may not be properly aligned or locked in place.

Moderate risk, FDA, Device defect

ConvaTec EsteemBody Drainable Pouches

Convatec EsteemBody Drainable Pouch may leak due to a manufacturing issue.

Moderate risk, FDA, Manufacturing problem

Stryker Cub Pediatric Crib

The Cub Pediatric Crib is missing two access door warning labels.

Moderate risk, FDA, Labeling error

STA Liatest D-Di

After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.

Moderate risk, FDA, Device defect

2 recalls

Howmedica Osteonics MICS3 Angled Sagittal Saw Attachment

The MICS3 Angled Sagittal Saw Attachment has screws that may loosen and detach during use.

Moderate risk, FDA, Device defect

Welch Allyn Spot Vision Screener VS100

The Welch Allyn Spot Vision Screener VS100 may have a flickering display that can cause seizures in susceptible people.

Moderate risk, FDA, Software defect

1 recall

Centricity Universal Viewer Software

Centricity Universal Viewer Software has a cybersecurity vulnerability that may expose user login credentials.

Moderate risk, FDA, Software defect

1 recall

Abbott Diagnostics Scarborough ID NOW Influenza A & B 2

The ID NOW Influenza A & B 2 has a higher occurrence of invalid rates.

Moderate risk, FDA, Device defect

4 recalls

Insulet Omnipod 5 Pods

Omnipod 5 Pods may have a tear causing insulin to leak inside, leading to under-delivery or cessation of insulin.

High risk, FDA, Manufacturing problem

Medline Medcrest Surgical Gowns and Surgical Drapes

Medline Medcrest Surgical Gowns may experience premature delamination, which can cause brief delays in patient care and risk of infection.

Moderate risk, FDA, Device defect

Lutronic CLARITY II Laser System

The Clarity II Laser System can spark or pop and potentially burn patients.

Moderate risk, FDA, Device defect

Altruan Strep A At-Home Self-Tests

Altruan GmbH is recalling its Wondfo Streptococcal A At-Home Self-Test, Clearest Strep-A Cassette Test, and Bisaf Strep A Self-Test because of product not cleared by the FDA.

Moderate risk, FDA, Unapproved product

3 recalls

International Life Sciences Artelon FlexBand Dynamic Matrix and FlexBand Plus

Artelon FlexBand devices failed bacterial endotoxin testing.

Moderate risk, FDA, Contamination

Beckman Coulter Chemistry Analyzers AU5800 and DxC 700 AU

Beckman Coulter Mishima K.K is recalling its Chemistry Analyzer Au5800 and DxC 700 Au because A delay in results may occur.

Moderate risk, FDA, Software defect

EndoVive Safety PEG Kit

The EndoVive Safety PEG Kit contains ChloraPrep Triple Swabsticks with open or compromised seals.

Moderate risk, FDA, Sterility problem

3 recalls

Waldemar Link Endo-Model Replacement Plateaus and Connection Components

Endo-Model Replacement Plateau and SL Connection Components may have a bushing that detaches from the screw shaft.

Moderate risk, FDA, Device defect

GEM Premier 5000

GEM Premier 5000 PAK may experience increased Process Control Solution Not Detected errors during warm-up, causing ejection and delays.

Moderate risk, FDA, Device defect

Physio-Control Infant/Child Reduced Energy Defibrillation Electrodes

Infant/Child Reduced Energy Defibrillator Electrodes may delaminate, which can affect defibrillation.

Moderate risk, FDA, Device defect

1 recall

Penner Pacific Bathing Spas

The Penner Pacific Bathing Spa lacks a unique device identifier.

Low risk, FDA, Device defect

1 recall

Raz Mobile Shower Commode Chairs

Mobile shower commode chairs may be reinstalled without properly engaging the outside rear seat brackets that keep the seat in place.

Moderate risk, FDA, Device defect

1 recall

Vascutek Gelsoft Plus and Gelweave Vascular Grafts

Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life.

Moderate risk, FDA, Labeling error

3 recalls

Olympus Single Use Biopsy Valve

The Olympus Single use Biopsy Valve can detach rubber fragments during use.

Moderate risk, FDA, Foreign object

Datascope CS100 and CS300 Intra-Aortic Balloon Pumps

The CS100 Iabp and CS300 Iabp have battery runtime and cycle specifications that need to be updated.

Moderate risk, FDA, Device defect

STA Liatest Free Protein S

The STA Liatest Free Protein S kit may show out-of-range results and underestimate free protein S levels in normal plasma.

Moderate risk, FDA, Device defect

2 recalls

Aesculap MINOP Trocar

The Minop Trocar 150MM 4 Wking CHANNEL6.0MM may have a trocar shaft that is too long.

Moderate risk, FDA, Device defect

Atellica CH Urine Albumin (UAlb)

Atellica CH Urine Albumin may report falsely depressed results for samples above 40.0 mg/dL.

Moderate risk, FDA, Device defect