CLASS II ONGOING Device recall · Reported 18 Sep 2024 · FDA Enforcement Report
Medline convenience kits containing semi-rigid suction recalled
MEDLINE INDUSTRIES, LP - Northfield is recalling Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB, distributed nationwide in the US. The recall was initiated on 27 Jun 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3120-2024
- FDA event ID
- 95128
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Jun 2024
- FDA classified
- 11 Sep 2024
- Reported
- 18 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 27 Jun 2024 | Recall initiated by company | |
| 11 Sep 2024 | Classified by FDA | +76 days |
| 18 Sep 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
XXX
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ59921B; b) AMB VITRECTOMY, Pack Number DYNJ59921BH; c) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923B; d) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923BH; e) AMB CUSTOM EYE, Pack Number DYNJ59924B; f) AMB CUSTOM EYE, Pack Number DYNJ59924BH; g) CATARACT-30843, Pack Number DYNJVB91139
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Questions about this recall
Is Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB recalled?
Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB on 27 Jun 2024. The recall is Class II and its status is Ongoing. Recall number Z-3120-2024.
Why was it recalled?
XXX
Which lots are affected?
a) DYNJ59921B: UDI/DI case 40195327037148, UDI/DI each 10195327037147, Lot Numbers: 23LBS025, 24ABY181; b) DYNJ59921BH: UDI/DI case 40195327037148, UDI/DI each 10195327037147, Lot Numbers: 23LBS025, 24ABY181; c) DYNJ59923B: UDI/DI case 40195327043217, UDI/DI each 10195327043216, Lot Numbers: 23LBF664, 23LBS053, 24ABY182; d) DYNJ59923BH: UDI/DI case 40195327043217, UDI/DI each 10195327043216, Lot Numbers: 23LBF664, 23LBS053, 24ABY182; e) DYNJ59924B: UDI/DI case 40195327036967, UDI/DI each 10195327036966, Lot Numbers: 23LBD909; f) DYNJ59924BH: UDI/DI case 40195327036967, UDI/DI each 10195327036966, Lot Numbers: 23LBD909; g) DYNJVB91139: UDI/DI case 40195327607105, UDI/DI each 10195327607104, Lot Numbers: 24CLA670, 24CLA895
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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