| 2025-12-12 |
Class II
|
Ongoing |
Z-1367-2026 |
Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060 |
— |
Due to damage to outer tray that can potentially compromise the sterile barrier |
| 2025-11-06 |
Class II
|
Ongoing |
Z-0887-2026 |
Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T, |
— |
Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously s… |
| 2025-08-21 |
Class II
|
Ongoing |
Z-2638-2025 |
Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Vencl… |
— |
Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in… |
| 2025-02-05 |
Class I
|
Ongoing |
Z-1244-2025 |
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: … |
— |
Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer… |
| 2024-09-30 |
Class II
|
Ongoing |
Z-0467-2025 |
Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 … |
— |
Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0371-2025 |
The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedur… |
— |
The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and yellow signal wires were soldered on swapped ports of th… |
| 2024-08-02 |
Class II
|
Ongoing |
Z-3206-2024 |
BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Bio… |
— |
Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be c… |
| 2024-07-10 |
Class II
|
Ongoing |
Z-3062-2024 |
Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lu… |
— |
Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is… |
| 2023-11-14 |
Class II
|
Ongoing |
Z-0676-2024 |
BD Recanalization System, REF: BDRECANSYSTEM |
— |
Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-mi… |
| 2023-11-08 |
Class II
|
Ongoing |
Z-0643-2024 |
Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G… |
— |
The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed … |
| 2023-08-10 |
Class II
|
Ongoing |
Z-0027-2024 |
Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016 |
— |
Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohi… |
| 2023-04-11 |
Class II
|
Ongoing |
Z-1564-2023 |
Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM |
— |
Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle f… |
| 2023-02-28 |
Class II
|
Ongoing |
Z-1260-2023 |
Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK |
— |
The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirem… |
| 2023-01-04 |
Class II
|
Ongoing |
Z-1051-2023 |
Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter R… |
— |
Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable). |
| 2022-12-22 |
Class II
|
Ongoing |
Z-1108-2023 |
The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol… |
— |
An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding. |
| 2022-04-22 |
Class II
|
Ongoing |
Z-1273-2022 |
REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO, |
— |
There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following dr… |
| 2022-01-20 |
Class II
|
Ongoing |
Z-0800-2022 |
SAFE-T PLUS ATRAUMATIC ADULT LP TRAY |
— |
Due to lumbar puncture tray manometer failure mode of leaking and mating issues. |
| 2022-01-20 |
Class II
|
Ongoing |
Z-0799-2022 |
LUMBAR PUNCTURE DRUG FREE TRAY 22G |
— |
Due to lumbar puncture tray manometer failure mode of leaking and mating issues. |
| 2022-01-20 |
Class II
|
Ongoing |
Z-0798-2022 |
ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY |
— |
Due to lumbar puncture tray manometer failure mode of leaking and mating issues. |
| 2022-01-20 |
Class II
|
Ongoing |
Z-0797-2022 |
SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT |
— |
Due to lumbar puncture tray manometer failure mode of leaking and mating issues. |
| 2022-01-20 |
Class II
|
Ongoing |
Z-0796-2022 |
LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL |
— |
Due to lumbar puncture tray manometer failure mode of leaking and mating issues. |
| 2022-01-20 |
Class II
|
Ongoing |
Z-0795-2022 |
LUMBAR PUNCTURE TRAY ADULT 18G X 3.5 |
— |
Due to lumbar puncture tray manometer failure mode of leaking and mating issues. |
| 2022-01-20 |
Class II
|
Ongoing |
Z-0794-2022 |
SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT |
— |
Due to lumbar puncture tray manometer failure mode of leaking and mating issues. |
| 2022-01-20 |
Class II
|
Ongoing |
Z-0793-2022 |
ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G |
— |
Due to lumbar puncture tray manometer failure mode of leaking and mating issues. |
| 2022-01-20 |
Class II
|
Ongoing |
Z-0792-2022 |
LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP |
— |
Due to lumbar puncture tray manometer failure mode of leaking and mating issues. |
| 2022-01-20 |
Class II
|
Ongoing |
Z-0791-2022 |
LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5 |
— |
Due to lumbar puncture tray manometer failure mode of leaking and mating issues. |
| 2022-01-20 |
Class II
|
Ongoing |
Z-0790-2022 |
Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer |
— |
Due to lumbar puncture tray manometer failure mode of leaking and mating issues. |
| 2021-08-24 |
Class II
|
Terminated |
Z-0154-2022 |
Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single… |
— |
Due to misbranded products shipped to customers. |
| 2021-08-24 |
Class II
|
Terminated |
Z-0153-2022 |
Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, … |
— |
Due to misbranded products shipped to customers. |
| 2021-07-27 |
Class II
|
Ongoing |
Z-0002-2022 |
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 1088… |
— |
Potential for needle protector to become fully dislodge exposing infusion needle which could result in needle stick. |
| 2021-06-23 |
Class II
|
Ongoing |
Z-2249-2021 |
TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration… |
— |
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile. |
| 2021-06-23 |
Class II
|
Ongoing |
Z-2248-2021 |
EJM4011 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. |
| 2021-06-23 |
Class II
|
Ongoing |
Z-2247-2021 |
TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshi… |
— |
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile. |
| 2021-03-25 |
Class II
|
Terminated |
Z-1552-2021 |
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 58295… |
— |
Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements. |
| 2021-03-25 |
Class II
|
Terminated |
Z-1551-2021 |
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 18295… |
— |
Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements. |
| 2021-03-25 |
Class II
|
Terminated |
Z-1550-2021 |
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 18295… |
— |
Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements. |
| 2021-01-14 |
Class II
|
Terminated |
Z-1289-2021 |
BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the … |
— |
Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during … |
| 2020-12-14 |
Class II
|
Ongoing |
Z-1899-2021 |
VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F 14/40/1200mm OUS; VENEL1406… |
— |
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system. |
| 2020-12-14 |
Class II
|
Ongoing |
Z-1898-2021 |
VENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10040 /Venovo 8F 10/40/1200mm OUS; VENEL1006… |
— |
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system. |
| 2020-12-14 |
Class II
|
Ongoing |
Z-1897-2021 |
VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL16040 Venovo 10F 16/40/1200mm OUS VENEL1606… |
— |
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system. |
| 2020-10-01 |
Class II
|
Terminated |
Z-0080-2021 |
Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usag… |
— |
Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon size is 6mm x 40mm, however included is a 5mm x 40mm balloon. Use… |
| 2020-03-17 |
Class II
|
Terminated |
Z-1689-2020 |
Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Produ… |
— |
Sterility compromised due to packaging pouches that may not be sealed properly |
| 2020-01-15 |
Class II
|
Ongoing |
Z-1964-2020 |
BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-End… |
— |
The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling. |
| 2020-01-03 |
Class II
|
Terminated |
Z-1434-2020 |
Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, packaged individually in sterile pouches, 5 pouche… |
— |
Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for… |
| 2020-01-03 |
Class II
|
Terminated |
Z-1433-2020 |
Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches… |
— |
Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for… |
| 2020-01-03 |
Class II
|
Terminated |
Z-1432-2020 |
Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches, 5 pouches/c… |
— |
Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for… |
| 2020-01-03 |
Class II
|
Terminated |
Z-1431-2020 |
Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pou… |
— |
Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for… |