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.
- 2023-11-01FDA-DeviceAmerican Contract Systems, Inc.Class IICVS PCSU SJH, REF SJCV48J
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
- 2023-11-01FDA-DeviceAmerican Contract Systems, Inc.Class IIRobotics Pack SAH, REF SAR530M
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
- 2023-11-01FDA-DeviceAmerican Contract Systems, Inc.Class IIBreast Plastics Pack, REF BBPL20D
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
- 2023-11-01FDA-DeviceAmerican Contract Systems, Inc.Class IILAVH, REF BBLV21C
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
- 2023-11-01FDA-DeviceAmerican Contract Systems, Inc.Class IIGeneral Pack, REF BBGP31C
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
- 2023-11-01FDA-DeviceMedtronic Sofamor Danek USA IncClass IIGrafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
- 2023-11-01FDA-DeviceMedtronic Sofamor Danek USA IncClass IIGrafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
- 2023-11-01FDA-DeviceMedtronic Sofamor Danek USA IncClass IIGrafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
- 2023-11-01FDA-DeviceMedtronic Sofamor Danek USA IncClass IIGrafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
- 2023-11-01FDA-DeviceMedtronic Sofamor Danek USA IncClass IIGrafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
- 2023-11-01FDA-DeviceMedtronic Sofamor Danek USA IncClass IIGrafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
- 2023-11-01FDA-DeviceMedtronic Sofamor Danek USA IncClass IIGrafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
- 2023-11-01FDA-DeviceOmega Medical Imaging, Inc.Class IIOmega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
An actuator separated from the pivot mechanism on a lower monitor boom system column. The lower boom became detached at the point shown and was restrained by the installed safety cable.
- 2023-11-01FDA-DeviceEMPATICA SRLClass IIEmbrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S
May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.
- 2023-11-01FDA-DeviceSmith & Nephew, Inc.Class IIJOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.
- 2023-11-01FDA-DeviceSmith & Nephew, Inc.Class IIJOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.
- 2023-11-01FDA-DeviceOmega Medical Imaging, Inc.Class IIOmega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
An actuator separated from the pivot mechanism on a lower monitor boom system column and became detached and was restrained by the installed safety cable at one location.
- 2023-11-01FDA-DeviceImpedimed LimitedClass IISOZO Bilateral Arm L-Dex Software
Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex assessment, which could result in under-recognition of early lymphedema, which could result in delay in early intervention, and more aggressive intervention.
- 2023-11-01FDA-DevicePreat CorpClass IIPreat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental
The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
- 2023-11-01FDA-DevicePreat CorpClass IIPreat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
- 2023-11-01FDA-DevicePreat CorpClass IIPreat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
- 2023-11-01FDA-DeviceCardinal Health 200, LLCClass IMonoject" 60 mL Syringe Luer-Lock Tip Soft Pack
Demonstrated recognition and compatibility issues with syringe infusion pumps.
- 2023-11-01FDA-DeviceCardinal Health 200, LLCClass IMonoject" 35 mL Syringe Luer-Lock Tip Soft Pack
Demonstrated recognition and compatibility issues with syringe infusion pumps.
- 2023-11-01FDA-DeviceCardinal Health 200, LLCClass IMonoject 20 mL Syringe Luer-Lock Tip Soft Pack
Demonstrated recognition and compatibility issues with syringe infusion pumps.
- 2023-11-01FDA-DeviceCardinal Health 200, LLCClass IMonoject" 12 mL Syringe Luer-Lock Tip Soft Pack
Demonstrated recognition and compatibility issues with syringe infusion pumps.
- 2023-11-01FDA-DeviceCardinal Health 200, LLCClass IMonoject" 6 mL Syringe Luer-Lock Tip Soft Pack
Demonstrated recognition and compatibility issues with syringe infusion pumps.
- 2023-11-01FDA-DeviceCardinal Health 200, LLCClass IMonoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
Demonstrated recognition and compatibility issues with syringe infusion pumps.
- 2023-11-01FDA-DeviceGE HealthcareClass IIUniversal Viewer Workflow Manager, Image processing radiological system
When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer.
- 2023-11-01FDA-DeviceGE HealthcareClass IICentricity Universal Viewer Workflow Manager, Image processing radiological system
When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer.
- 2023-11-01FDA-DeviceSmiths Medical ASD Inc.Class IIPortex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Specifically, this issue affected a total of 31,900 kits under the FGSKU# 4599P-1 and Lot# 4331283. Tubes without caps have the potential to generate delayed or erroneous test results and/or exposure to infectious blood.
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