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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80017

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

Open FDA event record

Event summary

Timeline bucket
April 24, 2018
Product types
Device
Classifications
Class II
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

6 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 6

MEDLINE Sterile* Needle Counter, 100Ct. Double Magnet / Foam Block, reorder: DYNJNC100F Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.

Z-1931-2018
Recall number
Z-1931-2018
Initiated
April 24, 2018
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
14208 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.

Code information

Lot Numbers: 67016114502, 67017014501, 67017024503, 67017034501, 67017044504, 67017054501, 67017054504, 67017064503, 67017074501, 67017074502, 67017084502, 67017094501, 67017104501, 67017114501

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates

device · product 2 of 6

MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC40A Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.

Z-1932-2018
Recall number
Z-1932-2018
Initiated
April 24, 2018
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
38464 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.

Code information

Lot Numbers: 67016114501 67016114502 67016114503 67016124501 67016124503 67016124504 67017024501 67017024502 67017024503 67017024504 67017034503 67017064503 67017084503 67017094501 67017094502 67017104501 67017104502

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates

device · product 3 of 6

MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Magnet, reorder: DYNJNC40F Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.

Z-1933-2018
Recall number
Z-1933-2018
Initiated
April 24, 2018
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
220608 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.

Code information

Lot Numbers: 67016114501 67016114502 67016114503 67016124502 67016124503 67016124504 67017014501 67017024501 67017024502 67017024503 67017024504 67017034501 67017034503 67017044503 67017044504 67017044505 67017054501 67017054502 67017054503 67017054504 67017064501 67017064502 67017064503 67017064504 67017074501 67017074502 67017084501 67017084502 67017104501

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates

device · product 4 of 6

MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.

Z-1934-2018
Recall number
Z-1934-2018
Initiated
April 24, 2018
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
80200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.

Code information

Lot Numbers: 67016114502 67016124501 67016124502 67016124507 67017014501 67017024502 67017034501 67017034503 67017064502 67017074502 67017084502 67017084503 67017094501 67017094503 67017094505 67017104501 67017114501 67017114502

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates

device · product 5 of 6

MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.

Z-1935-2018
Recall number
Z-1935-2018
Initiated
April 24, 2018
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
23150 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.

Code information

Lot Numbers: 67016114502 67017014501 67017024502 67017054501

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates

device · product 6 of 6

MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas, Gold Standard/Standard Or/Oro y Estander, 40 Ct. Foam Block / Magnet with Blade Remover, Coussinet en mousse pour 40 aiguilles /Magnetise avec quitte-lame Or, 40 Ct Bloque de espuma / Iman Con extractor de hoja - Oro, REF NC40FBRGS Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.

Z-1936-2018
Recall number
Z-1936-2018
Initiated
April 24, 2018
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
2600 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.

Code information

Lot Numbers: 67016114502 67016124502 67017014501 67017024502 67017064502 67017064503 67017074501 67017074502 67017084502 67017084503 67017104501

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates