Medical Device Recalls

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7,959 medical device recalls from federal enforcement feeds.

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Showing 3,351–3,400 of 7,959

Medical Device Recall · April 23, 2025
Mozarc Medical US LLC
Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Potential breach of sterile barrier packaging.
Class II
Medical Device Recall · April 23, 2025
Mozarc Medical US LLC
Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Potential breach of sterile barrier packaging.
Class II
Medical Device Recall · April 23, 2025
Mozarc Medical US LLC
Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Potential breach of sterile barrier packaging.
Class II
Medical Device Recall · April 23, 2025
Beckman Coulter Ireland, Inc.
Apo B Reagent, REF: OSR6143
The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.
Class III
Medical Device Recall · April 23, 2025
VIRTUAL INCISION CORPORATION
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
The MIRA Surgical System Software Version 4.0.3 loaded on the Surgeon Control Console may have the potential to exhibit interrupted motion on the display screen, caused by a software latency between the movement of the hand controllers and the movement of the Surgical Minibot arms.
Class II
Medical Device Recall · April 23, 2025
Mozarc Medical US LLC
Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Potential breach of sterile barrier packaging.
Class II
Medical Device Recall · April 23, 2025
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
Class II
Medical Device Recall · April 23, 2025
Mozarc Medical US LLC
MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Potential breach of sterile barrier packaging.
Class II
Medical Device Recall · April 23, 2025
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
Class II
Medical Device Recall · April 22, 2025
ICU Medical, Inc.
ICU Medical Plum Solos, Item number 400011001; infusion pump
Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
Class II
Medical Device Recall · April 22, 2025
ICU Medical, Inc.
ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
Class II
Medical Device Recall · April 22, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PACK-LF SKU DYNJ44805M 3. CRANIOTOMY SKU CDS982719V CDS982719W DYNJ904168F
Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
Class I
Medical Device Recall · April 22, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
Class I
Medical Device Recall · April 22, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY CDS, SKU CDS983467J 4. CRANIOTOMY PACK, SKU DYNJ85807A
Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
Class I
Medical Device Recall · April 22, 2025
3M Company
3M Ranger Irrigation Fluid Warming Set, REF 24750
Notice was issued to clarify flow rates related to the inlet fluid temperature.
Class II
Medical Device Recall · April 22, 2025
C-RAD POSITIONING AB
Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+
Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
Class II
Medical Device Recall · April 22, 2025
Ethicon Endo-Surgery Inc
Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.
Class I
Medical Device Recall · April 21, 2025
Becton Dickinson Infusion Therapy Systems, Inc.
BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguar
Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in therapy delay.
Class II
Medical Device Recall · April 21, 2025
American Contract Systems, Inc.
LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Model: NCTK31L All convenience kits contain Specialist Blend Cast Padding, It
Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality that may lead to a delay or prolonged treatment/procedure/therapy.
Class II
Medical Device Recall · April 21, 2025
Numed Inc
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.
Class II
Medical Device Recall · April 21, 2025
Capnia Inc
Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to insufficient aeration of the cannula's carbon filter prior to sealing, which may lead to higher than expected ETOCc scores during clinical evaluations.
Class II
Medical Device Recall · April 17, 2025
C.R. Bard Inc
Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300
Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
Class I
Medical Device Recall · April 17, 2025
Straumann USA LLC
WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
Incorrect blister labelling.
Class II
Medical Device Recall · April 17, 2025
Cook Incorporated
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Class II
Medical Device Recall · April 17, 2025
Cook Incorporated
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Class II
Medical Device Recall · April 17, 2025
C.R. Bard Inc
Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100
Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
Class I
Medical Device Recall · April 17, 2025
C.R. Bard Inc
Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ray Opaque Rubber
Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
Class I
Medical Device Recall · April 17, 2025
Cook Incorporated
Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN MWCE-18S-3/2-TORNADO (GPN G08261), RPN MWCE-18S-3/2-
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
Class II
Medical Device Recall · April 17, 2025
C.R. Bard Inc
Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
Class I
Medical Device Recall · April 17, 2025
C.R. Bard Inc
Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110
Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
Class I
Medical Device Recall · April 16, 2025
Remote Diagnostic Technologies Ltd.
Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer)
software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.
Class II
Medical Device Recall · April 16, 2025
Luminex Corporation
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test
It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.
Class II
Medical Device Recall · April 15, 2025
Remote Diagnostic Technologies Ltd.
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May reboot after intermittent connection with Smart Mount, 4) 12-lead ECG measurements with Louvain algorithm and software before vx.36 could produce inaccurate rhythm/morphology statements.
Class II
Medical Device Recall · April 15, 2025
Siemens Healthcare Diagnostics, Inc.
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.
Class II
Medical Device Recall · April 15, 2025
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.
Class II
Medical Device Recall · April 14, 2025
Augmedics Ltd.
Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed to assist surgeons in placing pedicle scre
The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.
Class II
Medical Device Recall · April 14, 2025
Prismatik Dentalcraft, Inc.
Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewell HT" Implant Twist Drill is indicated to prepare the site for
Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
Class II
Medical Device Recall · April 14, 2025
Straumann USA LLC
Plus Initial Drill, Article Number: 103.170;
The referred batch was produced without the laser engraving of 7 mm.
Class II
Medical Device Recall · April 14, 2025
Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
Class II
Medical Device Recall · April 13, 2025
Microtek Medical, Inc.
Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Drape, 8mm Adapter Plug Kit REF AP8MMN UDI code: (01)10748426139
Due to non-sterile products being labeled as sterile
Class II
Medical Device Recall · April 11, 2025
Medical Depot Inc.
iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.
Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
Class I
Medical Device Recall · April 11, 2025
Integra LifeSciences Corp. (NeuroSciences)
CODMAN Disposable Perforator, 14mm. Cranial perforator.
Inadequate weld that can potentially cause the product to disassemble.
Class I
Medical Device Recall · April 11, 2025
LeMaitre Vascular, Inc.
Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Class II
Medical Device Recall · April 11, 2025
Centerline Biomedical Inc
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
Class I
Medical Device Recall · April 11, 2025
LeMaitre Vascular, Inc.
TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E16
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Class II
Medical Device Recall · April 11, 2025
LeMaitre Vascular, Inc.
Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Class II
Medical Device Recall · April 11, 2025
Nipro Renal Soultions USA, Corporation
MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).
Potential for the presence of visible foreign matter.
Class I
Medical Device Recall · April 11, 2025
Integra LifeSciences Corp. (NeuroSciences)
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Inadequate weld that can potentially cause the product to disassemble.
Class I
Medical Device Recall · April 10, 2025
Tornier S.A.S.
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
Class II
Medical Device Recall · April 10, 2025
3M Company
3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
Field action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet temperature for Ranger Blood/Fluid Warming High Flow Sets.
Class I