Medical Device Recalls
RSS ↗7,979 medical device recalls from federal enforcement feeds.
Showing 7,001–7,050 of 7,979
- Class II
Medical Device Recall · February 27, 2024
Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx OnlyInadequate reprocessing validation evidence
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44BThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50DThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52EThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Class I
Medical Device Recall · February 27, 2024
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, intoCADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Upstream Occlusion, 2. Stop and Power Keys Unresponsive, 3. Manual Mode Air Detector, 4. Single Bubble Air Detection, 5. Error Codes Not Displayed at Power Up, 6. Audible Alarm, 7. Low Sensitivity Air in Line Detection Threshold, 8. PharmGuard Server Password. Smiths Medical corrected many of the issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent CADD software (v4.3 - 2023) installed on your pumps.
- Class I
Medical Device Recall · February 27, 2024
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidThe CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58FThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-64HThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-54EThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Class II
Medical Device Recall · February 27, 2024
Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CEInadequate reprocessing validation evidence
- Class II
Medical Device Recall · February 27, 2024
Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx OnlyInadequate reprocessing validation evidence
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58FThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Class I
Medical Device Recall · February 27, 2024
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nervesThe CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.
- 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
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48DThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48DThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Class II
Medical Device Recall · February 27, 2024
VITROS Performance Verifier IThe issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-52EThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Class II
Medical Device Recall · February 27, 2024
VITROS Performance Verifier IIThe issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-50DThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Class II
Medical Device Recall · February 26, 2024
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, the user was unable to attach the CT Localizer to perform stereotactic Imaging. Attachment of the localizer is typically accomplished by fully screwing in the four thumbscrews of the localizer into the threaded holes found on the top surface of the Skull Anchor Key.
- Class II
Medical Device Recall · February 26, 2024
MEDLINE INDUSTRIES, LP - Northfield
Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUSThe firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. However, the firms Receiving Dept. accepted these units into inventory
- Class I
Medical Device Recall · February 26, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID; (2) REF DYNJ18865, Polyurethane Cuff 6.5 mm ID; (3) REF DYNJ18870, Polyurethane Cuff 7.Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. There were also reports the suction pump is difficult to connect or detaches during use.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
Siemens Medical Solutions USA, Inc.
ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10GOn ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion STERILE TRACH BRUSH, Product Code 6225STProduct may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
- Class II
Medical Device Recall · February 23, 2024
Siemens Medical Solutions USA, Inc.
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10AOn ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582AProduct may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR CURETTE (505629), Product Code 67050; c) STERILE FOX DERMAL CURETTE, 5MM(32923Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion STERILE #16 RUBBER BAND, Product Code EB16Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product Code 66225; b) ST. KELLY HEMO W/TIPS (SK8039), Product Code 66565; c) STERILE BUTTERFLY PROBE (P837)Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion STERILE BLOOD COLLECTION TUBE,10ML, Product Code 6430STProduct may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Product Code 66520; b) STERILE TOWEL CLAMP, Product Code A547ST; c) ST TOWEL CLAMPS NON PERFORATING (P/S), Product CodeProduct may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion PICC LINE SECUREMENT KIT, Product Code IVS565Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code 66165; b) STERILE WEBSTER NEEDLEHOLDER, Product Code 66185; c) STERILE ADSON FORCEP SERR (598), Product CodeProduct may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient liftsPatient lift hanger bar may come loose, which could potentially pose risks to patients.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660; b) STERILE SMALL 2 PRONG SKIN HOOK (25754), Product Code 67105; c) STERILE NEWS TRACH HOOK(83300), ProductProduct may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Product Code 60265 MEDLINE manual surgical kits labeled as: a) SUTURE REMOVALProduct may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), Product Code 66145; c) STERILE STRT KELLY HEMOSTAT (SK8039), PProduct may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6; c) DENTAL INSTRUMENT KIT, Product Code DH760Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generatSteel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system which blocks the arm if the cable is cut off does not work properly, may result in patient injury
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) STERILE UTERINE DILATOR 1MM/2MM, Product Code HUD12ST; c) HEGAR UTERINE DILATOR,Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.