Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2024-04-17FDA-DeviceQiagen Sciences LLCClass IIEZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model Number: 9003230
Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost
- 2024-04-17FDA-DevicePhilips North AmericaClass IIPHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-sectional images of the body Model Number: 728143
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
- 2024-04-17FDA-DeviceStryker CommunicationsClass IIChromophare Surgical Light System , REF CH00000001
Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.
- 2024-04-17FDA-DeviceSynovo ProductionClass IIFemoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 01-03-0044 01-03-0045 01-03-0047 01-03-0049 01-03-0051 01-03-0052
Medical device components were marketed without FDA clearance
- 2024-04-17FDA-DeviceSynovo ProductionClass IIACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 01-02-4760 01-02-4962 01-02-5164 01-02-5266
Medical device components were marketed without FDA clearance
- 2024-04-17FDA-DeviceSynovo ProductionClass IIACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0554 01-01-0556 01-01-0558 01-01-0560 01-01-0562 01-01-0564 01-01-0566
Medical device components were marketed without FDA clearance and without FDA approval
- 2024-04-17FDA-DeviceConvaTec, IncClass IIConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/market unit.
The product does not meet sterility assurance level.
- 2024-04-17FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIBed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3), b) Medline SwivAssist Bar, Model Number MDS6800SWIVRH (individual)
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.
- 2024-04-17FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIBed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS6800BAMMS
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.
- 2024-04-17FDA-DeviceHuman Care Hc Sweden AbClass IIAltair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts
Patient lift hanger bar may come loose, which could potentially pose risks to patients.
- 2024-04-17FDA-DeviceFresenius Kabi USA, LLCClass ILVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
- 2024-04-17FDA-DeviceMicrobiologics IncClass IIKWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
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.
- 2024-04-17FDA-DeviceRAYSEARCH LABORATORIES ABClass IIRayStation 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.
- 2024-04-17FDA-DeviceOlympus Corporation of the AmericasClass IIHemostasis Probe, Model: CD-B622LA
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.
- 2024-04-10FDA-DeviceAbbott GmbHClass IIAlinity i Anti-HCV Reagent Kit, List Number 08P0521
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).
- 2024-04-10FDA-DeviceAbbott GmbHClass IIARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
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).
- 2024-04-10FDA-DeviceNavinetics IncClass IINaviNetics Skull Anchor Key and Drill Kit, REF NN1215
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.
- 2024-04-10FDA-DeviceWright Medical Technology, Inc.Class IIstryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
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.
- 2024-04-10FDA-DeviceAbbott LaboratoriesClass IIARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
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.
- 2024-04-10FDA-Device3M Company - Health Care BusinessClass II3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; and 3M Tube Securement Device, Large, 2.2 IN/PO x 3.5 IN/PO, REF 1501U, Sterile. Product is packaged 1 device per pouch, 25 pouches per primary carton, and 4 primary cartons per shipper box.
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.
- 2024-04-10FDA-DeviceKarl Storz EndoscopyClass IIKarl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only
Inadequate reprocessing validation evidence
- 2024-04-10FDA-DeviceKarl Storz EndoscopyClass IIKarl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
Inadequate reprocessing validation evidence
- 2024-04-10FDA-DeviceKarl Storz EndoscopyClass IIKarl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only
Inadequate reprocessing validation evidence
- 2024-04-10FDA-DeviceCovidien, LPClass IICovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
- 2024-04-10FDA-DeviceCovidien, LPClass IICovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
- 2024-04-10FDA-DeviceCovidien, LPClass IICovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
- 2024-04-10FDA-DeviceCovidien, LPClass IICovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
- 2024-04-10FDA-DeviceCovidien, LPClass IICovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
- 2024-04-10FDA-DeviceCovidien, LPClass IICovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
- 2024-04-10FDA-DeviceCovidien, LPClass IICovidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
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