Medical device recalls
38751 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2021-08-18FDA-DeviceBiomet, Inc.Class IIArcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item Number: 11-301314
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- 2021-08-18FDA-DeviceBiomet, Inc.Class IIArcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- 2021-08-18FDA-DeviceBiomet, Inc.Class IIArcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number: 11-301311
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- 2021-08-18FDA-DeviceBiomet, Inc.Class IIArcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number: 11-301310
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- 2021-08-18FDA-DeviceBiomet, Inc.Class IIArcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Item Number: 11-301302
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- 2021-08-18FDA-DeviceBiomet, Inc.Class IIArcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- 2021-08-18FDA-DeviceBiomet, Inc.Class IIArcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- 2021-08-18FDA-DeviceBeckman Coulter Inc.Class IIACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
- 2021-08-18FDA-DeviceBeckman Coulter Inc.Class IIACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
- 2021-08-18FDA-DeviceBeckman Coulter Inc.Class IIAccess SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720;
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
- 2021-08-18FDA-DeviceBeckman Coulter Inc.Class IIACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
- 2021-08-18FDA-DeviceSimpleware Product Group, SYNOPSYS NORTHERN EUROPEClass IISimpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in operator misunderstanding and errors during resampling or re-alignment of image data
- 2021-08-18FDA-DeviceSimpleware Product Group, SYNOPSYS NORTHERN EUROPEClass IISimpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in operator misunderstanding and errors during resampling or re-alignment of image data
- 2021-08-18FDA-DeviceDutch Ophthalmic USA, Inc.Class IIThe device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g , Product Number 8525.201.
Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
- 2021-08-18FDA-DeviceExactech, Inc.Class IIExactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).
- 2021-08-18FDA-DeviceExactech, Inc.Class IIExactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).
- 2021-08-18FDA-DeviceBard Peripheral Vascular IncClass IITIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
- 2021-08-18FDA-DeviceBard Peripheral Vascular IncClass IIEJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
- 2021-08-18FDA-DeviceBard Peripheral Vascular IncClass IITJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 13G x 8.9 cm; TJM4011 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 11G x 10cm; TJC4011 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 11G x 10cm; TJM4008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 10cm; TJC4008 Jamshidi" Crown Bone Marrow Biopsy/
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
- 2021-08-18FDA-DeviceRichard Wolf GmbHClass IICUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323
Product labeled as Cutting Electrode may contain BIVAP electrode.
- 2021-08-18FDA-DeviceBioFire Diagnostics, LLCClass IIFilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.
- 2021-08-18FDA-DeviceMerit Medical Systems, Inc.Class IIMERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391
There is a potential that a package sheath contains an incorrect dilator.
- 2021-08-18FDA-DeviceSmith & Nephew Orthopaedics Ltd. (Aurora)Class IIsmith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
The nail head may become detached during surgery.
- 2021-08-18FDA-DeviceBeckman Coulter, Inc.Class IIKaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C10575 - Kaluza C Single User 1-year License C10576 - Kaluza C 10 User Network License C10577 - Kaluza C 5 User Network License C10578 - Kaluza C Single Perpetual Educational License C10579 - Kaluza C Single User 1-year Educational License C10580 - Kaluza C 10 User Network Educational License C10581 - Kaluza C 5 User Network Educational License and C21166 - Kaluza C Progr
Software anomalies that may lead to the generation of erroneous results.
- 2021-08-18FDA-DeviceCovidien LlcClass IICovidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA
Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintended thermal burn, hemorrhage, or tissue damage and a delay of treatment while an alternate device is located
- 2021-08-18FDA-DeviceMerit Medical Systems, Inc.Class IIPrelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
There is a potential that 7F sheaths are packaged as 10F sheaths.
- 2021-08-18FDA-DeviceMerit Medical Systems, Inc.Class IIPrelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
There is a potential that 7F sheaths are packaged as 10F sheaths.
- 2021-08-18FDA-DeviceAdvance Dx, Inc.Class IIAdvance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02 IFU: Advance Dx 100 SSE(Serum Separating Extraction) Technology BLOOD COLLECTION INSTRUCTIONS
Due to high glucose test results when using the blood collection cards.
- 2021-08-18FDA-DeviceNEOSTEOClass IICannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.
Traces of corrosion on the laser marking was detected on cannulated graduated drill bit, which could lead to the emission of wear / corrosion particles in the operated area, potentially leading to the following risks: Inflammation, pain, allergy, adverse tissue reaction. Device description: The drill bit is used to create the hole required for the introduction of the screw, it is suitable for Neosteo compression screws for cortical and spongy bone. Drilling depth can be read on the instrument. The shaft is coupled with the ¿4.5mm surgical motor using a AO ¿4.5mm male drive connexion. The countersink bit is coupled to a ¿1.0mm k-wire to ensure guiding while drilling. The instrument is packaged in a plastic sheath sealed by welding.
- 2021-08-18FDA-DeviceCordis CorporationClass IICordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.
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