Recalled medical devices and their FDA enforcement class.
Olympus recalls POWERSEAL 5mm 23cm curved jaw sealers due to potential mislabeling as 37cm devices. Affected units may be confused with larger models.
IMRIS Imaging recalls ORT300 operating room tables with specific part numbers due to potential mechanical failure causing unintended rotational movement during procedures, risking patient injury.
IMRIS recalls ORT200 operating room tables with potential mechanical failure causing unintended patient movement during procedures. Affected units include specific serial numbers and part numbers. Contact IMRIS for remedy details.
Canon Medical recalls Alphenix INFX-8000C/F/V models due to potential loose fixing screws in ceiling suspension that could cause equipment failure during procedures.
Bard recalls specific needle kits for powered drivers due to risk of obturator locking to needle hub, potentially causing delayed therapy during emergency IV access.
Healthmark recalls ProChek-W and ProChek-Semi Quantitative Protein Tests with model PT-SQ-001 due to expired ingredients causing false negatives or positives. Serial numbers 200035-200040 and 30028 are affected.
Healthmark recalls ProChek-II devices with specific serial numbers due to expired ingredients causing false test results. Affected units may show inaccurate results, potentially leading to incorrect health decisions.
Spectral Instruments recalls Ami HTX devices due to potential momentary absence of X-Ray On banner during run readiness checks. No specific remedy provided in official notice.
Spectral Instruments recalls Lago X devices due to potential momentary absence of X-Ray On banner during run readiness check. No specific remedy provided in recall notice.
FUJIFILM recalls software version v7.4.310 for inaccurate ruler measurements in radiological image processing systems. Affected units include specific serial numbers and UDI codes.
Merge Healthcare recalls medical imaging workstations with software version V9.5 for inaccurate measurements. Affected units may display incorrect diagnostic data.
GE Medical Systems recalls Portrait Core Services Software V1.1 (Ref# 5700209) due to potential loss of patient monitoring and alarm reset issues. Affected units may require correction to prevent safety risks.
Dentsply Sirona Capsule Mixer Model 5546068 may cause electrical discharge when unplugged. Affected units have UDI:9336472005542 or serial numbers 0003-1533. Stop using immediately to avoid electrical hazards.
Midmark recalls specific IQecg ECG models with outdated software that may show incorrect heart rate readings. Affected units include certain serial numbers and software versions. Update to v10.1.0.18 or later to fix.
GE Medical Systems recalls Portrait Core Services SW Reload V1.1 software update that may cause loss of patient monitoring and reset alarm settings to factory defaults.
Midmark recalls specific ECG models with outdated software that may cause incorrect heart rhythm readings. Affected units include HD+12 and HD+15 models with software versions up to v10.1.0.18. Update software to fix the issue.
GE Medical Systems recalls Portrait Compute V1.2 software update (Ref# 5700592) due to potential loss of patient monitoring and alarm reset issues. Affected units may require correction to prevent safety risks.
GE Medical Systems recalls Portrait Core Services Software V1.0.5 (Ref# 5697353) due to potential loss of patient monitoring and alarm reset issues. Affected units may require software updates to prevent safety risks.
Paragonix recalls its KidneyVault Portable Renal Perfusion System (REF# PRGNX-8008-001) due to a firmware defect that may cause a blank screen and loss of preservation parameters. Affected units have specific serial numbers and software versions.
Thermo Fisher Diagnostics recalls Neisseria meningitidis Gp C 2ml/VL test kits with Product Number R30166901 that may not detect bacteria within 60 seconds. Affected lots have specific expiration dates.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is a leading manufacturer of medical imaging equipment and solutions.
Straumann recalls certain Bone Level Tapered implants that may be 12mm instead of 14mm. This could cause improper fit and complications during dental surgery. Affected implants have specific model numbers and lot codes.
PHILIPS
Biofire Defense recalls FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 with UDI-DI code (01)00851458005136 due to potential outbreak strain mismatch. Affected units may not detect certain pathogens accurately.
Beckman Coulter recalls DxC 500i Clinical Analyzer Modules with software version 1.5 or lower that may generate incorrect patient test results when importing new Parameter Packages.
Beckman Coulter recalls DxC 500 AU Clinical Analyzer Modules with software version 1.5 or lower that may generate incorrect patient test results after importing new parameter packages.
BMC Medical Co., Ltd. is a leading manufacturer of medical devices and equipment. Our products are designed to meet the highest standards of quality and safety.
ConMed recalls 5.5mm GENESYS CrossFT Suture Anchors with possible incorrect patient implant cards, risking wrong device identification. Affected units have specific reference numbers.
Boston Scientific recalls Suture Cinch Long 1pk endoscopic tissue approximation devices that may fail to deploy the cinch implant or cut sutures as intended. Affected units have specific lot numbers and expiration dates.
Hollister recalls select lots of 17cm hydrophilic urethral catheters due to manufacturing defects that may cause genitourinary trauma or bleeding. Affected units include specific SKUs and lot numbers.
Boston Scientific recalls OverStitch Suture Cinch devices that may fail to deploy the cinch implant or cut suture as intended. Affected units have specific lot numbers and expiration dates.
Cardinal Health recalls specific surgical kits due to unexpected endotoxin level variations in MEDICOM Ritmed Neurological Sponges, which could pose health risks during medical procedures.
Cardinal Health recalls 11 surgical kit types due to unexpected endotoxin variability in Medicom Ritmed Neurological Sponges, which could pose risks during procedures.
Cardinal Health recalls Presource Kits with NEWNAN SMR PACK (Catalog SEN21SPPMB) due to unexpected endotoxin variability in Neurological Sponges. Affected lots from 2019-2020 may pose risks.
Cardinal Health 200, LLC
Cardinal Health 200, LLC product list with detailed information including part numbers, lot numbers, and UDI-DI codes.
Cardinal Health 200, LLC
Cardinal Health recalls specific presource kits with neuro sponges that have unexpected endotoxin level variations. These kits may pose risks during medical procedures.
Cardinal Health 200, LLC
Gentherm Medical recalls Innercool Coolblue Console Model STx due to overheating risk causing device shutdown. Affected units have specific serial numbers.
Gentherm recalls Model 233 thermal regulators due to overheating causing shutdowns. Affected units have specific serial numbers and UDI codes. Contact for return instructions.
Medtronic recalls MiniMed 640G insulin pumps with model numbers MMT-1711 and MMT-1712 that may have been damaged by improper cleaning, risking incorrect insulin delivery and health complications.
Medline recalls specific neonatal breathing circuits due to potential overheating that could cause infant breathing problems. Affected models include HUD78001KIT to HUD88017KIT kits. Stop using immediately if you own these products.
Medtronic recalls MiniMed 670G insulin pumps with specific model numbers due to potential cleaning issues causing insulin delivery errors. Affected users should contact Medtronic for details.
Siemens Healthineers recalls Immulite 2000 Syphilis Screen due to potential false negatives in syphilis testing. Affected units may miss infections; contact for remedy.
Siemens Healthineers recalls Immulite 2000 Syphilis Screen systems that may report false negatives for syphilis tests, risking undetected infections. Affected units include specific lot codes and reference numbers.
Medtronic recalls MiniMed 780G insulin pumps with specific model numbers due to potential damage from incompatible cleaning products, which could cause incorrect insulin delivery and health risks.
Medline recalls Hudson RCI heated breathing circuits (SKU HUD78019) due to potential infant respiratory failure from sporadic heating failures. Affected units may show discoloration, melting, or burning smells. Stop using immediately to prevent serious breathing issues.
Kico recalls ARVIS Surgical Navigation System Gen 2 (model IN-29200) due to potential image tilt in eyepiece. This may affect surgical alignment accuracy during procedures like knee or hip replacements.
Siemens Healthcare recalls Syva EMIT 2000 Quinidine Assay due to potential inaccurate quinidine measurements, risking suboptimal patient treatment and life-threatening cardiac issues. Affected units include specific lot numbers.
Gentherm recalls Blanketrol II Model 222S thermal regulators due to overheating risk causing shutdowns. Affected units have specific serial numbers.
Beckman Coulter recalls Emit 2000 Quinidine Assay kits with specific lot numbers due to potential for inaccurate quinidine measurements, risking suboptimal patient treatment and possible life-threatening cardiac issues.
Medline recalls neonatal breathing circuits with potential sporadic failure causing infant respiratory issues. Discard or return affected units to avoid risks of airway obstruction and breathing complications.
OBP Medical recalls X-Small ER-Spec vaginal speculums with LED light due to potential burr on plastic blade that could cause sharp edges for patient or provider.
Straumann recalls GM Helix dental implants with possible packaging mismatch. Incorrect implants could cause bone compression during installation if bone volume is sufficient.
Medline recalls specific surgical convenience kits with potentially contaminated components. Affected kits include LAVH, GYN ABDOMINAL CDS, and other surgical kits with listed SKUs and lot numbers. Consumers should check their kits against the provided details.
Medline recalls convenience kits labeled MAJOR HEAD AND NECK PPS with SKU DYNJ9425991S due to potential contamination. Affected kits have specific UDI/DI and lot numbers.
Medline recalls 10 different convenience kits with potentially contaminated components. Consumers should check product labels for specific SKUs and lot numbers to determine if their kit is affected.
Medline recalls 16 different GYN robotic surgical kits with potentially contaminated components. Consumers should stop using these kits immediately to avoid health risks.
Medline recalls two convenience kits (FEMORAL PACK SKU DYNJ909393A and FEVAR SKU DYNJ910295D) due to potentially contaminated components. Affected kits have specific lot numbers and were sold in 2023-2024.
