Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90849

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

Open FDA event record

Event summary

Timeline bucket
July 04, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medicina Uk Ltd

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

8 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 8

Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD

Z-0107-2023
Recall number
Z-0107-2023
Initiated
July 04, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Medicina Uk Ltd
Quantity
9 boxes (900 syringes)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

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

Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

Code information

UDI-DI: (01)05060278508146 Batch number: HM17121, HM18051, HM18080, HM18120, HM18141, HM19007, HM19016, HM19059, HM19083, HM19130, HM19144, HM20005, HM20054, HM21044, HM22018

Distribution pattern

Nationwide

device · product 2 of 8

Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05

Z-0108-2023
Recall number
Z-0108-2023
Initiated
July 04, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Medicina Uk Ltd
Quantity
1 box (100 syringes)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

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

Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

Code information

UDI-DI: (01)05060278508153(17)250400(10)HM20055 Batch number: HM17099, HM18010, HM18052, HM18103, HM18113, HM18143, HM19009, HM19018, HM19061, HM19084, HM19132, HM19146, HM20006, HM20032, HM20055, HM20095, HM21037, HM21069, HM22019

Distribution pattern

Nationwide

device · product 3 of 8

Medicina Oral Tip Syringe 0.5ml Code: OT005

Z-0109-2023
Recall number
Z-0109-2023
Initiated
July 04, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Medicina Uk Ltd
Quantity
120 boxes (12,000 Syringes)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

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

Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

Code information

UDI-DI: (01)05060278503417 Batch number: HM19024

Distribution pattern

Nationwide

device · product 4 of 8

Medicina Oral Tip Syringe 1ml Code: OT01

Z-0110-2023
Recall number
Z-0110-2023
Initiated
July 04, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Medicina Uk Ltd
Quantity
29 boxes (2900 syringes)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

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

Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

Code information

UDI-DI: (01)05060278503424 Batch number: HM18147, HM19012, HM19025, HM19088, HM19164, HM20063 HM21015, HM21072

Distribution pattern

Nationwide

device · product 5 of 8

Medicina Oral Tip Syringe 2.5ml Code: OT25

Z-0111-2023
Recall number
Z-0111-2023
Initiated
July 04, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Medicina Uk Ltd
Quantity
20 boxes (2000 syringes)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

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

Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

Code information

UDI-DI:(01)05060278503431 Batch number: HM19026, HM19165, HM20019, HM20064, HM21061

Distribution pattern

Nationwide

device · product 6 of 8

Medicina Reusable Oral syringe 1ml Code: OTH01

Z-0112-2023
Recall number
Z-0112-2023
Initiated
July 04, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Medicina Uk Ltd
Quantity
111 boxes (11,100 syringes)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

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

Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

Code information

UDI-DI: (01)05056115402869 (01)05056115402869(17)260700(10)HM21053 Batch number: HM18041, HM21053

Distribution pattern

Nationwide

device · product 7 of 8

Medicina Reusable Oral syringe 5ml Code: OTH05

Z-0113-2023
Recall number
Z-0113-2023
Initiated
July 04, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Medicina Uk Ltd
Quantity
26 boxes (2600 syringes)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

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

Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

Code information

UDI-DI: (01)05056115403491 (01)05056115403491(17)260700(10)HM21055 Batch number: HM18043, HM20020, HM21055

Distribution pattern

Nationwide

device · product 8 of 8

Medicina Reusable Oral syringe 2.5ml Code: OTH25

Z-0114-2023
Recall number
Z-0114-2023
Initiated
July 04, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Medicina Uk Ltd
Quantity
20 boxes (2000 syringes)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

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

Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

Code information

UDI-DI: (01)05056115402876 Batch number: HM18042, HM21019, HM21054

Distribution pattern

Nationwide