Z-1320-2026Class I

Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10...

Name: Z-1320-2026 Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10...
Creator: Medline Industries, LP
Published: 2025-12-22
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-12-22 / Open, Classified

FDA source

Medline Industries, LP began a recall of Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81105RH 81172RH; Abbott Inquiry... on 2025-12-22. FDA classified it as Class I and gives the reason as "These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1320-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-12-22
Posted: 2026-02-06
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81105RH 81172RH; Abbott Inquiry Steerable Diagnostic Catheter 20 Elec. 2-10-2mm 81202RH; Abbott Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81483RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81102RH 81104RH 81174RH 81531RH 81532RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 5mm 81107RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 2-5-2mm 81402RH 81404RH 81405RH 81474RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81473RH
Product code: NLH Catheter, Recording, Electrode, Reprocessed
Reason for recall: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
FDA root cause: Under Investigation by firm
Action: On December 22, 2025, the firm issued Urgent Medical Device Recall letters as a follow-up to an earlier action in 2025 for the same issue, but newly identified item numbers and lots of previously identified item numbers. Notably, the products associated with the new/updated action are to be destroyed by the customer on-site for credit, and not returned to the manufacturer. ***Updated 5/18/26*** The firm issued an expanded notification on 5/15/26 which expanded the action to include on additional lot of product. These devices were not expired at the time of the original notification but have since expired.
Quantity in commerce: 311
Distribution: Distribution US nationwide.
Product codes and lots: 81105RH UDI-DI 10197344133253 Lot EP250618; 81172RH UDI-DI 10197344133284 Lot EP250618; 81202RH UDI-DI 10197344133307 Lot EP250618; 81483RH UDI-DI 10197344133444 Lot EP250618; 81102RH UDI-DI (case) 20197344133236¿ (ea) 10197344133239 Lot EP250618; 81104RH UDI-DI 10197344133246 Lot EP250618; 81174RH UDI-DI 10197344133291 Lot EP250618; 81531RH UDI-DI 10197344133512 Lot EP250618; 81532RH UDI-DI 10197344133529 Lot EP250618; 81107RH UDI-DI 10197344133260 Lot EP250618; 81402RH UDI-DI 10197344133352 Lot EP250618; 81404RH UDI-DI 10197344133376 Lot EP250618; 81405RH UDI-DI 10197344133383 Lot EP250618; 81474RH UDI-DI 10197344133437 Lot EP250618; 81473RH UDI-DI 10197344133420 Lot EP250618

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1320-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1319-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1320-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1321-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1322-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1323-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1324-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1325-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06

Product code NLH

K242225Class IIMedline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic CatheterSurgical Instrument Service and Savings, Inc. / cleared 2024-11-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)