Medical Device Recalls
RSS ↗7,979 medical device recalls from federal enforcement feeds.
Showing 6,951–7,000 of 7,979
- Class III
Medical Device Recall · March 4, 2024
NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSterile, Product Code BB-S05EO; b. 12mL Oral Syringe Blue NonSterile, Product CoThe expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
- Class III
Medical Device Recall · March 4, 2024
NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSterile, Product Code BC-S05EO; b. 12mL Oral Syringe Orange NonSterile, ProductThe expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
- Class III
Medical Device Recall · March 4, 2024
NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA-S05EO; b. 12mL Oral Syringe Amber NonSterile, ProductThe expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
- Class II
Medical Device Recall · March 4, 2024
X-Guide Handpiece Adaptor Sleeve 3, Model P010727The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.
- Class II
Medical Device Recall · March 1, 2024
Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary anPackaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- Class I
Medical Device Recall · March 1, 2024
Mojo Full Face with Headgear, All SizesUpdate to contraindications and warning language due to CPAP masks containing magnets.
- Class I
Medical Device Recall · March 1, 2024
iQ 2 Nasal Vented MaskUpdate to contraindications and warning language due to CPAP masks containing magnets.
- Class II
Medical Device Recall · March 1, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PUDENDAL KIT, REF DYNJRA2210; c) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046;Trumpet Needle Guide ring can detach when excessive pressure is applied.
- Class II
Medical Device Recall · March 1, 2024
Olympus Corporation of the Americas
Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-640LDue to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions for Use, which details critical specifications regarding electrosurgical unit compatibility and output due to reports of serious injury
- Class II
Medical Device Recall · March 1, 2024
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
- Class II
Medical Device Recall · March 1, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).Potential for positively biased results due to signal reduction over shelf life.
- Class II
Medical Device Recall · March 1, 2024
N-LHP-928, HeNe Laser System, 35 mWThese laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.
- Class I
Medical Device Recall · March 1, 2024
Phantom 2 Nasal Vented MaskUpdate to contraindications and warning language due to CPAP masks containing magnets.
- Class II
Medical Device Recall · March 1, 2024
Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0 G01559 2) DCHN-18-10.0-U G05040 3) DCHN-18-15.0 G00850 4) DCHN-22-10.0 G00852Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- Class II
Medical Device Recall · March 1, 2024
Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. REFEPackaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- Class II
Medical Device Recall · March 1, 2024
Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in thePackaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- Class II
Medical Device Recall · March 1, 2024
Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell which could cause minor burns, cuts or abrasions, or low current electrical shock to the user.
- Class I
Medical Device Recall · March 1, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnlyPotential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
- Class I
Medical Device Recall · March 1, 2024
Mojo 2 Full Face AAV Non Vented Mask, All SizesUpdate to contraindications and warning language due to CPAP masks containing magnets.
- Class I
Medical Device Recall · March 1, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnlyPotential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
- Class II
Medical Device Recall · March 1, 2024
25-LHP-928, HeNe Laser System, 25 mWThese laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.
- Class I
Medical Device Recall · March 1, 2024
Mojo 2 Full Face Non Vented Mask, All SizesUpdate to contraindications and warning language due to CPAP masks containing magnets.
- Class II
Medical Device Recall · March 1, 2024
Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REPackaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- Class II
Medical Device Recall · March 1, 2024
Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary aPackaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- Class II
Medical Device Recall · March 1, 2024
Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. REFERENCE PART NUMBER (RPN): DTVN-5.0-19-10.0- YUEH ORDER NUMPackaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- Class II
Medical Device Recall · March 1, 2024
Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renalPackaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- Class II
Medical Device Recall · March 1, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience trayTrumpet Needle Guide ring can detach when excessive pressure is applied.
- Class I
Medical Device Recall · March 1, 2024
Mojo Non Vented Full Face Mask with Headgear, All SizesUpdate to contraindications and warning language due to CPAP masks containing magnets.
- Class II
Medical Device Recall · March 1, 2024
25-LHP-828, HeNe Laser System, 35 mWThese laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.
- Class II
Medical Device Recall · March 1, 2024
Olympus Corporation of the Americas
Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-645LDue to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions for Use, which details critical specifications regarding electrosurgical unit compatibility and output due to reports of serious injury
- Class I
Medical Device Recall · March 1, 2024
Mojo 2 Full Face Vented Mask, All SizesUpdate to contraindications and warning language due to CPAP masks containing magnets.
- Class II
Medical Device Recall · February 29, 2024
Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, oThe reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable may fully or partially disconnect from the flex cable assembly fittings during normal operation. The DxI 9000 Access Immunoassay Analyzer may generate a System Event log message that indicates PnP errors. Any cancelled tests will have an associated SYS flag. The analyzer may enter the Red-system status because of this issue. The analyzer also may not eject RVs, where unbound conjugate could potentially splash up on the sidewall of the RV, not being properly washed away, resulting in an artificially higher signal (RLU). The analyzer may not detect this splashing and continue with normal operation, which can cause false low or high erroneous results. Consequently, the analyzer may cancel in-progress tests. These errors could potentially cause delay reporting patient test results and patient treatments. The degree of the potential health hazard is dependent on the analytes that are potentially delayed, especially those analytes that would be used in the acute setting when treatment decisions are immediate. In this particular recall the highest risk analyte is troponin. Health consequences could include permanent impairment or possibly death if medical treatment decisions are delayed due to a delay in obtaining patient results. The issue was identified by Beckman Coulter Inc. manufacturing staff at their location in Brea California on February 29, 2024, during in-process acceptance inspection activities.
- Class II
Medical Device Recall · February 29, 2024
BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemicalEsculin, a substrate used in other panels and normally in A16 well, was found in A17 well. A17 in yeast panels is supposed to be an empty well and is not a part of the normal ID evaluation. However, A17 is checked for fluorescence and if anything is found, the system will abort the panel with the message Fluorescent interference has been detected . Esculin is expected to trigger this fluorescence and test cancellation.
- Class II
Medical Device Recall · February 29, 2024
BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemicalProducts were found to have confirmed drug cross contamination prior to release may lead to incorrect, inadequate, or absent antibiotic treatment or delay in results
- Class II
Medical Device Recall · February 28, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNLThe potential for trocar seal disengagement when using mesh products incorrectly with the device.
- Class II
Medical Device Recall · February 28, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSThe potential for trocar seal disengagement when using mesh products incorrectly with the device.
- Class II
Medical Device Recall · February 28, 2024
Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SBThe potential for trocar seal disengagement when using mesh products incorrectly with the device.
- Class II
Medical Device Recall · February 28, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNLThe potential for trocar seal disengagement when using mesh products incorrectly with the device.
- Class II
Medical Device Recall · February 28, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTThe potential for trocar seal disengagement when using mesh products incorrectly with the device.
- Class II
Medical Device Recall · February 28, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNLThe potential for trocar seal disengagement when using mesh products incorrectly with the device.
- Class II
Medical Device Recall · February 28, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTThe potential for trocar seal disengagement when using mesh products incorrectly with the device.
- Class II
Medical Device Recall · February 28, 2024
Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices.
- Class II
Medical Device Recall · February 28, 2024
Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIOA new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices.
- Class II
Medical Device Recall · February 28, 2024
Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices.
- Class II
Medical Device Recall · February 28, 2024
SEASPINE ORTHOPEDICS CORPORATION
Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
- Class II
Medical Device Recall · February 28, 2024
Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIOA new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices.
- Class II
Medical Device Recall · February 28, 2024
CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.XIt was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode.
- Class II
Medical Device Recall · February 28, 2024
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.XIt was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode.
- Class II
Medical Device Recall · February 27, 2024
O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.Failure of adhesive to secure the pole insert.
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66HThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell