Angiodynamics CAN 5F SINGLE XCELA PICC Recall: Bacterial Endotoxins Risk
Angiodynamics recalls CAN 5F SINGLE XCE:LA PICC kits with potential bacterial endotoxins. Affected units have specific catalog and lot numbers. Consumers should contact for details.
Lower-risk recall
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Contact the company
What happened, in plain English
Angiodynamics is recalling certain PICC kits due to possible unsafe levels of bacterial endotoxins. This could cause fever or infection if used improperly. The recall affects specific catalog and lot numbers. Read more at govinfonow.com/recall/71093-angiodynamics-can-5f-single-xcela-picc-recall-bacterial-endotoxins-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/71093-angiodynamics-can-5f-single-xcela-picc-recall-bacterial-endotoxins-risk · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2218-2018
Cite this page
“Angiodynamics CAN 5F SINGLE XCELA PICC Recall: Bacterial Endotoxins Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71093-angiodynamics-can-5f-single-xcela-picc-recall-bacterial-endotoxins-risk. Based on FDA recall #Z-2218-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2218-2018%22&limit=1).
Why it’s dangerous
Bacterial endotoxins (pyrogens) in the kits can cause fever or infection when injected into the body. This risk is higher if the kits are used improperly or if the endotoxin levels exceed safe limits.
Who’s affected
Patients using the CAN 5F SINGLE XCELA PICC kits with catalog number 60M701531 and specific lot numbers are most at risk. Healthcare providers who use these kits may also be affected.
How to tell if you have this one
Check for catalog number 60M701531 and lot numbers 5299826 or 5312185 on the kit packaging. The product is sold under the brand Angiodynamics.
- Brand
Angiodynamics- Category
Medical device
All 38 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2188-2018 | XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124; UPN: H965251240; Lot: 5303187 | 7 boxes |
| Z-2189-2018 | Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818; UPN: H965458180; Lot: 5303175, 5305572 | 50 boxes |
| Z-2190-2018 | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871; UPN: H965458710; Lot: 5303177 | 200 boxes |
| Z-2191-2018 | Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872; UPN: H965458720; Lot: 5304983 | 20 boxes |
| Z-2192-2018 | Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882; UPN: H965458820; Lot: 5301752 | 17 boxes |
| Z-2193-2018 | Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886; UPN: H965458860; Lot: 5303442 | 58 boxes |
| Z-2194-2018 | Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887; UPN: H965458870; Lot: 5305574 | 246 boxes |
| Z-2195-2018 | Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892; UPN: H965458920; Lot: 5304323 | 11 boxes |
| Z-2196-2018 | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalog Number 45-895; UPN: H965458950; Lot: 5304321 | 298 boxes |
| Z-2197-2018 | Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901; UPN: H965459011; Lot: G18012001, G18064125 | 86 boxes |
| Z-2198-2018 | BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490; UPN: H965464901; Lot: 5302405, 5312036, 5314940 | 190 boxes |
| Z-2199-2018 | BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810; UPN: H965468100; Lot: 5314926 | 23 boxes |
| Z-2200-2018 | RS TANDEM 5F DL XPP, Catalog Number 60M019881; UPN: H96560M0198811; Lot: 5299857 | 7 |
| Z-2201-2018 | RS 5F DL XPP, Catalog Number 60M030393; UPN: H96560M0303931; Lot: 5304317, 5304317 | 7 boxes |
| Z-2202-2018 | RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472; UPN: H96560M0354721; Lot: 5312194 | 3 boxes |
| Z-2203-2018 | RS 5F DL BIOFLO PICC, Catalog Number 60M071831; UPN: H96560M0718311; Lot: 5310191 | 12 boxes |
| Z-2204-2018 | RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M120196; UPN: H96560M1201961; Lot: 5314930 | 2 boxes |
| Z-2205-2018 | RS 5F DL BIOFLO PASV, Catalog Number 60M132324; UPN: H96560M1323241; Lot: 5312922 | 2 boxes |
| Z-2206-2018 | TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567; UPN: H96560M1405671; Lot: 5316349 | 1 box |
| Z-2207-2018 | 5F DL BIOFLO PASV, Catalog Number 60M141006; UPN: H96560M1410061; Lot: 5304286, 5318620 | 36 boxes |
| Z-2208-2018 | RS 5F DL BIOFLO PASV, Catalog Number 60M150373; UPN: H96560M1503731; Lot: 5303174 | 7 boxes |
| Z-2209-2018 | RS 5F DL BIOFLO PASV, Catalog Number 60M161567; UPN: H96560M1615671; Lot: 5316086 | 2 boxes |
| Z-2210-2018 | 5F DL BIOFLO PICC, Catalog Number 60M180592; UPN: H96560M1805921; Lot: 5313507, 5316369, 5318603, 5321025 | 12 boxes |
| Z-2211-2018 | RS 5F DL BIOFLO PASV, Catalog Number 60M181578; UPN: H96560M1815781; Lot: 5303172, 5310562 | 11 boxes |
| Z-2212-2018 | RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582; UPN: H96560M1815821; Lot: 5299859 | 13 boxes |
| Z-2213-2018 | RS 5F DL XPP KIT, Catalog Number 60M183104; UPN: H96560M1831041; Lot: 5310755 | 5 boxes |
| Z-2214-2018 | RS 5F DL BIOFLO PASV, Catalog Number 60M183481; UPN: H96560M1834811; Lot: 5301023, 5310193, 5312020 | 104 boxes |
| Z-2215-2018 | RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242; UPN: H96560M2322421; Lot: 5304324, 5316020 | 20 boxes |
| Z-2216-2018 | RS TANDEM 5F DL BIOFLO PICC, Catalog Number 60M250097; UPN: H96560M2500971; Lot: 5303198, 5320749 | 15 boxes |
| Z-2217-2018 | CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936; UPN: H96560M7009361; Lot: 5316398, | 2 boxes |
| Z-2218-2018 | CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531; UPN: H96560M7015311; Lot: 5299826, 5312185 | 17 boxes |
| Z-2219-2018 | CAN 5F DUAL XCELA PICC, Catalog Number 60M701532; UPN: H96560M7015321; Lot: 5300582, 5312582 | 27 boxes |
| Z-2220-2018 | Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003; UPN: H965750031; Lot: 5301074, 5304327, 5308920 | 99 boxes |
| Z-2221-2018 | BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-019; UPN: H965750191; Lot: 5301073, 5304893 | 132 boxes |
| Z-2222-2018 | BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire PG, Catalog Number 75-032; UPN: H965750325; Lot: 5312035 | 3 boxes |
| Z-2223-2018 | BioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-033; UPN: H965750335; Lot: 5310029, 5310762 | 81 boxes |
| Z-2224-2018 | BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-038; UPN: H965750385; Lot: 5301462, 5316413, 5320267 | 79 boxes |
| Z-2225-2018 | RS 5F DL XCELA PICC, Catalog Number 60M122272; UPN: M00160M1222721; Lot: 5312021 | 6 boxes |
What to do — step by step
Check Kit Details
Look for catalog number 60M701531 and lot numbers 5299826 or 5312185 on the product packaging.
Where it went and when
Where it was distributed
Distributed in 33 states and D.C., and outside the U.S.
FDA distribution: “The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2218-2018 (May 10, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2218-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.