April 17, 2024Medical DevicesFDA
Philips North America recalls PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intend
Hazard: Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide with the moved tabletop and be injured
April 17, 2024Medical DevicesFDA
Stryker Communications recalls Chromophare Surgical Light System , REF CH00000001
Hazard: Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.
April 17, 2024Medical DevicesFDA
Synovo Production recalls Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 0
Hazard: Medical device components were marketed without FDA clearance
April 17, 2024Medical DevicesFDA
Synovo Production recalls ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 01
Hazard: Medical device components were marketed without FDA clearance
April 17, 2024Medical DevicesFDA
Synovo Production recalls ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0
Hazard: Medical device components were marketed without FDA clearance and without FDA approval
April 17, 2024Medical DevicesFDA
ConvaTec, Inc recalls ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/i
Hazard: The product does not meet sterility assurance level.
April 17, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3), b) Medline Sw
Hazard: Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after the mandatory compliance requirement (ASTM F3186-17, Standard Specification for Adult Portable Bed Rails and Related Products and 16 CFR Part 1270, Safety Standard for Adult Portable Bed Rails ) and failed to meet all mandatory requirements outlined in these standards.
April 17, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS68
Hazard: Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after the mandatory compliance requirement (ASTM F3186-17, Standard Specification for Adult Portable Bed Rails and Related Products and 16 CFR Part 1270, Safety Standard for Adult Portable Bed Rails ) and failed to meet all mandatory requirements outlined in these standards.
April 17, 2024Medical DevicesFDA
Human Care Hc Sweden Ab recalls 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 li
Hazard: Patient lift hanger bar may come loose, which could potentially pose risks to patients.
April 17, 2024Medical DevicesFDA
Fresenius Kabi USA, LLC recalls LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Hazard: Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
April 17, 2024Medical DevicesFDA
Microbiologics Inc recalls KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for cultur
Hazard: The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with another fungal organism (Aspergillus brasiliensis). As a result, users may observe A. brasiliensis growth when using the control material.
April 17, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including som
Hazard: A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.
April 17, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls Hemostasis Probe, Model: CD-B622LA
Hazard: The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.
April 10, 2024Medical DevicesFDA
Abbott GmbH recalls Alinity i Anti-HCV Reagent Kit, List Number 08P0521
Hazard: Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).
April 10, 2024Medical DevicesFDA
Abbott GmbH recalls ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
Hazard: Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).
April 10, 2024Medical DevicesFDA
Navinetics Inc recalls NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
Hazard: Defective 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.
April 10, 2024Medical DevicesFDA
Wright Medical Technology, Inc. recalls stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
Hazard: Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide.
April 10, 2024Medical DevicesFDA
Abbott Laboratories recalls ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Hazard: The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis of myocardial infarction.
April 10, 2024Medical DevicesFDA
3M Company - Health Care Business recalls 3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; and 3M Tube Securement Device, Large, 2.2 I
Hazard: Manufacturing nonconformities are in some lots of the Tube Securement Device, such as the top film layer may be partially or completely missing and some devices may exhibit the appearance of an incorrect shape due to excess material not being removed from the product liner.
April 10, 2024Medical DevicesFDA
Karl Storz Endoscopy recalls Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only
Hazard: Inadequate reprocessing validation evidence
April 10, 2024Medical DevicesFDA
Karl Storz Endoscopy recalls Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
Hazard: Inadequate reprocessing validation evidence
April 10, 2024Medical DevicesFDA
Karl Storz Endoscopy recalls Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only
Hazard: Inadequate reprocessing validation evidence
April 10, 2024Medical DevicesFDA
Covidien, LP recalls Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL
Hazard: The potential for trocar seal disengagement when using mesh products incorrectly with the device.
April 10, 2024Medical DevicesFDA
Covidien, LP recalls Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
Hazard: The potential for trocar seal disengagement when using mesh products incorrectly with the device.
April 10, 2024Medical DevicesFDA
Covidien, LP recalls Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
Hazard: The potential for trocar seal disengagement when using mesh products incorrectly with the device.
April 10, 2024Medical DevicesFDA
Covidien, LP recalls Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
Hazard: The potential for trocar seal disengagement when using mesh products incorrectly with the device.
April 10, 2024Medical DevicesFDA
Covidien, LP recalls Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
Hazard: The potential for trocar seal disengagement when using mesh products incorrectly with the device.
April 10, 2024Medical DevicesFDA
Covidien, LP recalls Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
Hazard: The potential for trocar seal disengagement when using mesh products incorrectly with the device.
April 10, 2024Medical DevicesFDA
Covidien, LP recalls Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB
Hazard: The potential for trocar seal disengagement when using mesh products incorrectly with the device.
April 10, 2024Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Ureteral dilator, REF RBD014
Hazard: A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in our facility.