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Medical device recalls

Medical device recalls from FDA, newest first.
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4 recalls

Beta Bionics iLet Ace Pump Kit and Dosing Decision Software

The iLet Ace Pump Kit and Dosing Decision Software can be bypassed, allowing unauthorized access and potentially causing severe hypoglycemia.

Moderate risk, FDA, Device defect

1 recall

Stryker Sustainability Solution Color Cuff

The tourniquet cuffs can detach from the bladder at the welding connection.

Moderate risk, FDA, Device defect

1 recall

Brahms B.R.A.H.M.S PlGF Plus KRYPTOR Diagnostic Test

The B.R.A.H.M.S PlGF Plus Kryptor test may show out-of-range quality control values, potentially leading to falsely elevated sFlt-1/PlGF ratio results.

Moderate risk, FDA, Device defect

3 recalls

Medline Namic Angiographic Control Syringes and Medical Convenience Kits

NAMIC Angiographic Rotating Adaptor (RA) Control Syringes may unwind during use, causing a loose or full disconnection.

High risk, FDA, Device defect

Siemens Artis Pheno and Artis Icono Biplane Systems

ARTIS pheno and ARTIS Icono biplane, floor and ceiling may sporadically display a major increase of the x-ray dose applied to the patient.

Moderate risk, FDA, Device defect

Spacelabs Healthcare Multi-Parameter Command Module

The Multi-parameter Command Module has a circuit board issue that may cause inaccurate readings and delayed care.

Moderate risk, FDA, Device defect

1 recall

Tornier HRS Max Tuberosity Bodies and Trial

Tornier HRS Max parts were incorrectly labeled and are incompatible with the HRS Max system.

Moderate risk, FDA, Labeling error

4 recalls

Medtronic MiniMed and Paradigm Insulin Pumps

Over-delivery can cause severe hypoglycemia, altered mental status, seizure, coma, or death.

Moderate risk, FDA, Device defect

Burlington Medical Radiation Protection Apparel

Burlington Medical BAT Coverage may degrade over time, decreasing its lifespan.

Moderate risk, FDA, Device defect

Philips Respironics Trilogy EV300, Evo, Evo O2, and Evo Universal

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

High risk, FDA, Device defect

Cardinal Health Monoject Tuberculin Syringes

The outer packaging and blister pack label the product as a 1mL Luer Lock Tuberculin Syringe, but the syringes inside are U-100 Insulin syringes.

Moderate risk, FDA, Labeling error

3 recalls

Synthes 2.4 Volt Tap Locking and Cortex Screws

Bone taps have an incorrect thread due to a lot swap.

Moderate risk, FDA, Device defect

Olympus SOLTIVE Premium and Pro Laser Systems

The Soltive Pro and Premium laser systems may become inoperable and emit smoke or a burning smell.

Moderate risk, FDA, Device defect

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

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

Medline Sterile Radiology Procedure Kits

Sterile Radiology Procedure Kits may have a breach in sterile packaging, compromising sterility.

Moderate risk, FDA, Sterility problem

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

Straumann Custom Abutments

A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments.

Moderate risk, FDA, Manufacturing problem

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

1 recall

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

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

4 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

HealthCast "Vital Sync" Remote Patient Monitoring System

Alarms from the primary patient bedside monitor may not be transmitted or received on the remote system.

Moderate risk, FDA, Device defect