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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66080

11 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 14, 2013
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Medline Industries, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

11 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 11

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.

Z-1046-2014
Recall number
Z-1046-2014
Initiated
August 14, 2013
Classification
Class I
Status
Terminated
Recalling firm
Medline Industries, Inc.
Quantity
1,194 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack Number: DYNJ26855D; Lots: 13EB2046, 13EB8965

Distribution pattern

Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.

device · product 2 of 11

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.

Z-1047-2014
Recall number
Z-1047-2014
Initiated
August 14, 2013
Classification
Class I
Status
Terminated
Recalling firm
Medline Industries, Inc.
Quantity
768 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack Number: DYNJ39185; Lots: 13EB2046, 13FB1553, 13GB2605

Distribution pattern

Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.

device · product 3 of 11

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.

Z-1048-2014
Recall number
Z-1048-2014
Initiated
August 14, 2013
Classification
Class I
Status
Terminated
Recalling firm
Medline Industries, Inc.
Quantity
160 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack Number: DYNJ39747A; Lots: 13EB2095, 13EB3153, 13FB4157, 13RB0832, 13GB2692

Distribution pattern

Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.

device · product 4 of 11

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.

Z-1049-2014
Recall number
Z-1049-2014
Initiated
August 14, 2013
Classification
Class I
Status
Terminated
Recalling firm
Medline Industries, Inc.
Quantity
120 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack Number: DYNJ40926; Lot: 13FB4759

Distribution pattern

Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.

device · product 5 of 11

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.

Z-1050-2014
Recall number
Z-1050-2014
Initiated
August 14, 2013
Classification
Class I
Status
Terminated
Recalling firm
Medline Industries, Inc.
Quantity
304 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack Number: DYNJ41101; Lot: 13FB5744

Distribution pattern

Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.

device · product 6 of 11

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.

Z-1051-2014
Recall number
Z-1051-2014
Initiated
August 14, 2013
Classification
Class I
Status
Terminated
Recalling firm
Medline Industries, Inc.
Quantity
120 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack Number: DYNJ41103; Lots: 13GB5484, 13GB9975

Distribution pattern

Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.

device · product 7 of 11

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..

Z-1052-2014
Recall number
Z-1052-2014
Initiated
August 14, 2013
Classification
Class I
Status
Terminated
Recalling firm
Medline Industries, Inc.
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack Number: SAMP0144; Lots: 13CD2145, 13CD2146

Distribution pattern

Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.

device · product 8 of 11

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.

Z-1053-2014
Recall number
Z-1053-2014
Initiated
August 14, 2013
Classification
Class I
Status
Terminated
Recalling firm
Medline Industries, Inc.
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack Number: SAMP0213; Lot: 13CD1774

Distribution pattern

Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.

device · product 9 of 11

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.

Z-1054-2014
Recall number
Z-1054-2014
Initiated
August 14, 2013
Classification
Class I
Status
Terminated
Recalling firm
Medline Industries, Inc.
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack Number: SAMP0147; Lot: 13CD2146

Distribution pattern

Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.

device · product 10 of 11

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.

Z-1055-2014
Recall number
Z-1055-2014
Initiated
August 14, 2013
Classification
Class I
Status
Terminated
Recalling firm
Medline Industries, Inc.
Quantity
50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack Number: DYNJ40851; Lot: 13FB8753

Distribution pattern

Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.

device · product 11 of 11

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.

Z-1056-2014
Recall number
Z-1056-2014
Initiated
August 14, 2013
Classification
Class I
Status
Terminated
Recalling firm
Medline Industries, Inc.
Quantity
112 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack Number: DYNJ40904; Lot: 13GB9975

Distribution pattern

Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.