Recall archive
49 recalls · page 1 of 3
Reported Dec 29, 2021
Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions…
FDA (openFDA device enforcement)
Reported Dec 22, 2021
Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 24, 2021
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 10, 2021
Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 17, 2021
Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand · Product · Product details — Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead…
FDA (openFDA device enforcement)
Reported Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor Introducers and Guiding…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cook Inc.
Matched: Brand — There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in…
20 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 11, 2020
Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cook Inc.
Matched: Brand — Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire…
FDA (openFDA device enforcement)
Reported Oct 21, 2020
Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks.…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2020
Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — May contain excess glue within the handle of the delivery system, resulting in an inability to fully deploy the graft via the standard method or…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 15, 2020
Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — Identified products may contain a damaged bushing within the delivery system, which could potentially result in difficulty or an inability to fully…
FDA (openFDA device enforcement)
Reported Jun 10, 2020
Pressure Monitoring Set, C-PMS, G02838
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 20, 2020
Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon delivery system prior to deployment.…
FDA (openFDA device enforcement)
Reported Apr 1, 2020
Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — The printed expiration dates are incorrect.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 4, 2020
Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — The firm has identified factors which contributed to failures relating to thrombus formation and/or lumen occlusion reports, and is highlighting to…
FDA (openFDA device enforcement)
Reported Feb 12, 2020
Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient…
19 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2020
Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could lead to leakage from the Mac-Loc hub…
FDA (openFDA device enforcement)
Reported Dec 18, 2019
CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cook Inc.
Matched: Brand — A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 27, 2019
Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events…
73 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 26, 2019
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cook Inc.
Matched: Brand — Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 19, 2019
Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product.
FDA (openFDA device enforcement)
Reported Jun 12, 2019
Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — Affected products may have been manufactured with the catheter distal end hole too small
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 29, 2019
Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr 003500 G14916; 6.0 Fr 003600 G14836; 7.0…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand · Product · Product details — Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 20, 2019
Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cook Inc.
Matched: Brand · Product · Product details — The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle…
FDA (openFDA device enforcement)
Reported Mar 6, 2019
Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number G35569 The Entuit Secure…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Inc.
Matched: Brand — There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.
1 more product in this recall
FDA (openFDA device enforcement)
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