Biomedical Polymers Recalls Manual Diff Droppers Due to Cannula Failure
Biomedical Polymers is recalling Manual Diff Droppers because the metal cannula may break or fail to pierce blood specimen tubes.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The defect involves mechanical failure affecting sample preparation rather than direct patient injury or contamination.
Plain-English summary
Biomedical Polymers, Inc. is recalling 2,052,000 units of Manual Diff Droppers, Part Number CHB4001, which are used for preparing blood samples. The recall covers units with lot numbers 20180709A1C and 20180717A1C, identified by UPC (01) 50885380116009. These products were distributed nationwide in the United States.
The recall is being issued because the metal cannula of the device may break, leaving a broken piece in the blood specimen tube, or it may slide back into the plastic portion of the device instead of piercing the tube. This defect can compromise the integrity of the blood sample preparation process.
Consumers and healthcare facilities should stop using the affected Manual Diff Droppers immediately. Users should contact Biomedical Polymers, Inc. for instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples.
- Manufacturer
- Biomedical Polymers, Inc.
- Affected units
- 2,052,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UPC: (01) 50885380116009 Lot numbers: 20180709A1C
- 20180717A1C
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Biomedical Polymers, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Biomedical Polymers, Inc.
See all →- ModerateBiomedical Polymers Recalls Hemo-Drop Blood Dispensers Due to Metal Cannula Defect
FDA (Devices) · 2019-11-13
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- HighMedtronic DLP One-Piece Pediatric Arterial Cannula Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- ModerateMedtronic DLP Vessel Cannula Recalled for Incorrect Labeling
FDA (Devices) · 2024-03-27
- SevereICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula
FDA (Devices) · 2020-05-13
- SevereICU Medical Recalls 10 Drop Primary IV Sets Due to Cannula Error
FDA (Devices) · 2020-05-13
- ModerateMedtronic Pediatric Arterial Cannulae Recalled for Incorrect Labeling
FDA (Devices) · 2025-01-29