Food, drugs, devices › Medline Industries, Inc.
Device recall: ANGIOGRAPHY PACK; REF: DYNJ26855D; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline;
FDA enforcement event 66080 is a device recall by Medline Industries, Inc. of Waukegan, IL, initiated 14 Aug 2013 and classified Class I, with 11 product records.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 6% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 19 Dec 2017. Initiation: voluntary: firm initiated. Medline Industries, Inc. has 61 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medline Industries, Inc., Waukegan, IL.
Reason for recall
"Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc."
Distribution
"Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1046-2014 | ANGIOGRAPHY PACK; REF: DYNJ26855D; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures. | 1,194 units | Class I | Terminated | 5 Mar 2014 |
| Z-1047-2014 | ANGIO PACK #2; REF: DYNJ39185; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures. | 768 units | Class I | Terminated | 5 Mar 2014 |
| Z-1048-2014 | HEART CATH CUSTOM PACK; REF: DYNJ39747A; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures. | 160 units | Class I | Terminated | 5 Mar 2014 |
| Z-1049-2014 | CATH LAB CUSTOM PACK; REF: DYNJ40926; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures. | 120 units | Class I | Terminated | 5 Mar 2014 |
| Z-1050-2014 | CATH TRAY; REF: DYNJ41101; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures. | 304 units | Class I | Terminated | 5 Mar 2014 |
| Z-1051-2014 | CATH PACK; REF: DYNJ41103; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures. | 120 units | Class I | Terminated | 5 Mar 2014 |
| Z-1052-2014 | STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.. | 10 units | Class I | Terminated | 5 Mar 2014 |
| Z-1053-2014 | STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures. | 10 units | Class I | Terminated | 5 Mar 2014 |
| Z-1054-2014 | STERILE SAMPLE BUILD; REF: SAMP0147; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures. | 5 units | Class I | Terminated | 5 Mar 2014 |
| Z-1055-2014 | CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures. | 50 units | Class I | Terminated | 5 Mar 2014 |
| Z-1056-2014 | CATH PACK; REF: DYNJ40904; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures. | 112 units | Class I | Terminated | 5 Mar 2014 |
Context
Other enforcement events for Medline Industries, Inc.
All 61 events for Medline Industries, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 19 Dec 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.