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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88430

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

Open FDA event record

Event summary

Timeline bucket
August 05, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
M.D.L. S.r.l.

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

5 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 5

Bone Marrow Transplantation biopsy needle

Z-2489-2021
Recall number
Z-2489-2021
Initiated
August 05, 2021
Classification
Class II
Status
Terminated
Recalling firm
M.D.L. S.r.l.
Quantity
21,518 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility assurance may be compromised.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility assurance may be compromised.

Code information

Model PI1535/100, Lot Numbers: 3620D Model PIL1410/75, Lot Numbers: 1617A Model PIL1435/100, Lot Numbers: 1617A Model PIL1510/75, Lot Numbers: 3620D, 3620E Model PIL1535/100, Lot Numbers: 5216C, 3620D Model PIL1610/75, Lot Numbers: 3620D, 3620E, 4120 Model PIL1635/100, Lot Numbers: 5216C Model PIL1835/100, Lot Numbers: 5216C Model PIP1410/50, Lot Numbers: 1617A Model PIP1430/70, Lot Numbers: 1617A Model PIP1510/50, Lot Numbers: 1217B, 1618A Model PIP1530/70, Lot Numbers: 1617A Model PIP1630/70, Lot Numbers: 1617A Model PIP1810/50, Lot Numbers: 0818, 1618A Model PIP1830/70, Lot Numbers: 1617A Model PJ0810, Lot Numbers: 3620D Model PJ1110, Lot Numbers: 3620D, 4920B Model PJ1306, Lot Numbers: 3620D Model PJE1110, Lot Numbers: 5216, 5216C, 1417A, 3517C, 4617, 0818, 1418, 2518A, 4018, 4318D, 5018, 1119B, 1119C, 1119A, 3620D Model PJK21110, Lot Numbers: 3616C, 3620D Model PJK21115, Lot Numbers: 3416C Model PJK21310, Lot Numbers: 3416C, 3620D Model PJT0810, Lot Numbers: 4220B, 4320D, 4320D Model PJT0815, Lot Numbers: 4220D, 4320E Model PJT1110, Lot Numbers: 1417A, 3620D, 3620D, 3620D, 4220B, 4220B, 4220B, 4220A, 4320F, 4320D Model PJT1115, Lot Numbers: 3620D, 4220B, 4320D Model PJT1306, Lot Numbers: 1417A, 3517C, 3620D, 3620E, 4220B, 4320D Model PJT1310, Lot Numbers: 3620D, 4220B, 4420A, 4320D Model PS0810, Lot Numbers: 2518A, 1119A Model PS1110, Lot Numbers: 4316, 4316A, 4316B, 4316B, 2618, 4018, 3620D Model PS1115, Lot Numbers: 3620D Model PS1306, Lot Numbers: 3620D Model PS1310, Lot Numbers: 3916, 3620D

Distribution pattern

Nationwide

device · product 2 of 5

Aspirated Cyto-Histological Biopsy needle

Z-2490-2021
Recall number
Z-2490-2021
Initiated
August 05, 2021
Classification
Class II
Status
Terminated
Recalling firm
M.D.L. S.r.l.
Quantity
2750 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility assurance may be compromised.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility assurance may be compromised.

Code information

Model PB1810; Lot 1617A Model PB1815; Lots 5216C and 3620D Model PB1820; Lot 5216C Model PB1825; Lot 5216C Model PB2010; Lot 1617A Model PB2015; Lots 5216C, 2618B, and 3620D Model PB2020; Lots 5216C and 1618A Model PB2110; Lot 5216C Model PB2115; Lot 5216C Model PB2120; Lot 1617A Model PB2215; Lot 5216C Model PB2220; Lots 5216C, 1618A, 3620D Model PB2225; Lot 2518A

Distribution pattern

Nationwide

device · product 3 of 5

Mammary Nodules Localization

Z-2491-2021
Recall number
Z-2491-2021
Initiated
August 05, 2021
Classification
Class II
Status
Terminated
Recalling firm
M.D.L. S.r.l.
Quantity
320 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility assurance may be compromised.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility assurance may be compromised.

Code information

Model Number PN2010, Lots: 3620D Model Number PN2012, Lots: 1317 Model Number PN2015, Lots: 3620D Model Number PNA2005, Lots: 5216C Model Number PNA2010, Lots: 3620D Model Number PNA2015, Lots: 3620D Model Number PNAX2005, Lots: 5216C Model Number PNS2010, Lots: 3620D Model Number PNS2015, Lots: 3620D Model Number PNX2010, Lots: 0817A Model Number PR2005, Lots: 5216C, 4920B Model Number PR2007, Lots: 5216C Model Number PR2010, Lots: 3620D Model Number PR2015, Lots: 3620D

Distribution pattern

Nationwide

device · product 4 of 5

Soft Tissue Biopsy Needles

Z-2492-2021
Recall number
Z-2492-2021
Initiated
August 05, 2021
Classification
Class II
Status
Terminated
Recalling firm
M.D.L. S.r.l.
Quantity
20,129 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility assurance may be compromised.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility assurance may be compromised.

Code information

Model MGK11210, Lot Numbers: 5216C Model MGK11410, Lot Numbers: 5216C, 1217B, 3620D Model MGK11413, Lot Numbers: 5216C Model MGK11415, Lot Numbers: 3620D Model MGK11610, Lot Numbers: 5216C, 3620D Model MGK11615, Lot Numbers: 3620D Model MGK11616, Lot Numbers: 5216C, 1217B Model MGK11620, Lot Numbers: 1617A Model MGK11810, Lot Numbers: 5216C Model MGK11816, Lot Numbers: 5216C Model MGK11820, Lot Numbers: 5216C, 1217B, 4617 Model MGK11825, Lot Numbers: 5216C, 1217B, 3620D, 3620E Model PD01415, Lot Numbers: 3620D, 3620E Model PD01416, Lot Numbers: 5216C, 1417A Model PD01420, Lot Numbers: 5216C Model PD01610, Lot Numbers: 5216C, 0817A, 0818, 1618A, 1918A, 3620D, 3620E Model PD01615, Lot Numbers: 3620D, 3620E Model PD01616, Lot Numbers: 5216C, 1417A Model PD01620, Lot Numbers: 5216C Model PD01810, Lot Numbers: 5216C, 0817A, 0817A, 1617A, 0818, 1618A, 1918A Model PD01816, Lot Numbers: 5216C, 0817A, 0817A, 1617A Model PD01820, Lot Numbers: 5216C, 2217A, 2217A Model PD02007, Lot Numbers: 1617A, 2217A, 0119 Model PD02010, Lot Numbers: 5216C, 0817A, 2217A, 1918A Model PD02016, Lot Numbers: 5216C, 0817A, 2217A Model PD02020, Lot Numbers: 5216C, 0817A Model PD0PP1407, Lot Numbers: 0718 Model PD0PP1410, Lot Numbers: 5216C, 3620D, 3620E Model PD0PP1415, Lot Numbers: 3620D, 3620E Model PD0PP1416, Lot Numbers: 5216C Model PD0PP1420, Lot Numbers: 5216C Model PD0PP1610, Lot Numbers: 5216C, 4018, 1119A, 3620D, 3620E Model PD0PP1615, Lot Numbers: 3620D, 3620E, 4220C Model PD0PP1616, Lot Numbers: 5216C, 1119A Model PD0PP1620, Lot Numbers: 5216C Model PD0PP1807, Lot Numbers: 4018, 0219 Model PD0PP1810, Lot Numbers: 1217B, 1417A, 2217A, 5018, 0219, 1119A Model PD0PP1815, Lot Numbers: 1417C Model PD0PP1816, Lot Numbers: 5216C, 1217B, 1417A, 2217A, 5018, 0219, 1119A Model PD0PP1820, Lot Numbers: 5216C, 1417A, 2217A, 2618B, 0219, 1119A Model PD0PP1825, Lot Numbers: 5216C, 1417A Model PD0PP2007, Lot Numbers: 1617A, 0119, 0219 Model PD0PP2010, Lot Numbers: 0417, 1417A, 2217A, 0918, 0219 Model PD0PP2016, Lot Numbers: 1417A, 2217A, 0818A, 0818B, 1218A, 0219, 1119A Model PD0PP2020, Lot Numbers: 1417A, 2217A, 0219, 1119A Model TY1410, Lot Numbers: 5216C, 1417A, 1817, 1618A, 3620D Model TY1412, Lot Numbers: 1617A Model TY1416, Lot Numbers: 5216C, 1417A Model TY1420, Lot Numbers: 1417A Model TY1610, Lot Numbers: 5216C, 0818, 1618A, 1918A, 3620D Model TY1612, Lot Numbers: 1618A Model TY1616, Lot Numbers: 5216C, 0817 Model TY1620, Lot Numbers: 5216C Model TY1810, Lot Numbers: 5216C, 0818, 1618A, 1918A, 3620D Model TY1812, Lot Numbers: 2217, 1618A Model TY1816, Lot Numbers: 5216C Model TY1820, Lot Numbers: 5216C, 1417A, 1417C, 0818, 1618A, 1918A Model TY1825, Lot Numbers: 5216C, 2217A, 1618A, 3620D Model TY1830, Lot Numbers: 1618A Model TY2010, Lot Numbers: 5216C Model TY2016, Lot Numbers: 5216C Model TY2020, Lot Numbers: 5216C, 1417A Model TYC1410, Lot Numbers: 5216C, 1417A Model TYC1412, Lot Numbers: 1617A Model TYC1416, Lot Numbers: 5216C Model TYC1810, Lot Numbers: 5216C, 2217A Model TYC1812, Lot Numbers: 2217 Model TYC1816, Lot Numbers: 5216C, 2217A Model TYC1820, Lot Numbers: 1417A, 2117A Model TYC2010, Lot Numbers: 5216C, 2217A Model TYC2016, Lot Numbers: 5216C, 2217A Model TYC2020, Lot Numbers: 1417A, 2117A, 2217A

Distribution pattern

Nationwide

device · product 5 of 5

General Manual surgical instrument

Z-2493-2021
Recall number
Z-2493-2021
Initiated
August 05, 2021
Classification
Class II
Status
Terminated
Recalling firm
M.D.L. S.r.l.
Quantity
4120 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility assurance may be compromised.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility assurance may be compromised.

Code information

Model MGC1413, Lot Numbers: 0817A Model MGC1825, Lot Numbers: 0817A Model MGP1410, Lot Numbers: 5216C Model MGP1412, Lot Numbers: 5216C Model MGP1612, Lot Numbers: 5216C Model MGP1820, Lot Numbers: 5216C Model MGP1825, Lot Numbers: 0817A Model PC1610, Lot Numbers: 3620D Model PC1810, Lot Numbers: 3620D Model PC1815, Lot Numbers: 1217B Model PM14075, Lot Numbers: 5216C Model PM1410, Lot Numbers: 3620D Model PM14114, Lot Numbers: 5216C Model PM1415, Lot Numbers: 5216C Model PM16075, Lot Numbers: 5216C Model PM1610, Lot Numbers: 3620D Model PM16114, Lot Numbers: 5216C Model PM1615, Lot Numbers: 5216C Model PM18075, Lot Numbers: 5216C Model PM18114, Lot Numbers: 5216C Model PM1815, Lot Numbers: 5216C Model VE1410, Lot Numbers: 3620D Model VES1825, Lot Numbers: 1417A

Distribution pattern

Nationwide