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Recall Observatory FDA recall evidence

Core noun

Device recall evidence

Joined enrichment rows that support device recall linkage and root-cause wording.

Indexed record set

39,516 evidence rows

Page 21 of 1581

Evidence Product Join Root cause
device-recall:cfres:183845 Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM). Official recall number · Z-0066-2021 Process design
device-recall:cfres:183636 Change Healthcare Radiology Solutions 14.0 Official recall number · Z-0072-2021 Process design
device-recall:cfres:184211 Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H787065970355 Official recall number · Z-0418-2021 Under Investigation by firm
device-recall:cfres:183964 ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 00-8065-652-26 Official recall number · Z-0376-2021 Device Design
device-recall:cfres:183963 ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 00-8065-652-22 Official recall number · Z-0375-2021 Device Design
device-recall:cfres:184032 3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally. Official recall number · Z-0417-2021 Unknown/Undetermined by firm
device-recall:cfres:183937 ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 45 mm Number: 00-8065-642-26 Official recall number · Z-0359-2021 Device Design
device-recall:cfres:183923 ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-32 Official recall number · Z-0356-2021 Device Design
device-recall:cfres:183979 ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm Number: 00-8065-658-26 Official recall number · Z-0388-2021 Device Design
device-recall:cfres:183892 ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-32 Official recall number · Z-0340-2021 Device Design
device-recall:cfres:184082 FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation. Official recall number · Z-0432-2021 Software design
device-recall:cfres:184018 SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally. Official recall number · Z-0404-2021 Unknown/Undetermined by firm
device-recall:cfres:183987 ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 59 mm Number: 00-8065-956-32 Official recall number · Z-0396-2021 Device Design
device-recall:cfres:181924 BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY Official recall number · Z-2567-2020 Device Design
device-recall:cfres:181976 Safe-T-Centesis 8 Fr Catheter Drainage Tray Official recall number · Z-2651-2020 Under Investigation by firm
device-recall:cfres:181689 CRANIOSCULPT C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process. Official recall number · Z-2597-2020 Under Investigation by firm
device-recall:cfres:181909 SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801741085482), PA-0029YN (UDI 00801741085499), PA-0030 (UDI 00801741085505), PA-0030YN (UDI 00801741085512), PA-0031 (UDI 00801741085529), PA-0031YN (UDI 00801741085536), PA-0032 (UDI 00801741085543), PA-0032YN (UDI 00801741085550), PA-0033 (UDI 00801741085567), PA-0033YN (UDI 00801741085574), PA-0034 (UDI 00801741085581), PA-0034YN (UDI 00801741085598), PA-0036 (UDI 00801741085604), PA-0038 (UDI 00801741085628), PA-0038YN (UDI 00801741085635) Official recall number · Z-2666-2020 Process control
device-recall:cfres:181468 BodyGuard Microset, REF: A100-163XES Official recall number · Z-2556-2020 Device Design
device-recall:cfres:181952 LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case Official recall number · Z-2642-2020 Packaging process control
device-recall:cfres:181936 CMExpress Microbore Sets, REF: A120-160C2YRV Official recall number · Z-2579-2020 Device Design
device-recall:cfres:181944 CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK Official recall number · Z-2587-2020 Device Design
device-recall:cfres:181687 ACUMED IMPACT 10CC. Product Number: 65-0110-S, UDI: 813845020269 - Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process. Official recall number · Z-2595-2020 Under Investigation by firm
device-recall:cfres:181722 SKAFFOLD CMF IMPRESS (MP), 5CC. Product Number: CMMP-IM05, UDI: 813845020689 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process. Official recall number · Z-2626-2020 Under Investigation by firm
device-recall:cfres:181708 OSTEOVATION EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 813845020047 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process. Official recall number · Z-2613-2020 Under Investigation by firm
device-recall:cfres:182117 LoFric Origo, Tiemann, 16in, FR12 urinary catheters Official recall number · Z-2644-2020 Equipment maintenance

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