Genesis BPS Recalls Pediatric Blood Filter Syringes for Regulatory Non-Compliance
Genesis BPS, LLC. is recalling 7,272 units of Pedi-Pak Pedi-Syringe Filter 60 mL syringes because the company failed to notify the FDA of material changes.
What this means for you
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 II due to a regulatory failure to notify the agency of material changes. The source text does not report any illnesses, injuries, or deaths, and the hazard is procedural rather than a direct physical defect causing harm, fitting the criteria for a moderate severity score.
Plain-English summary
Genesis BPS, LLC. is recalling 7,272 units of Pedi-Pak Pedi-Syringe Filter 60 mL syringes. These medical devices are intended for the preparation and delivery of small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and neonatal transfusion. The recall is being conducted because the company did not notify the U.S. Food and Drug Administration of its intent to introduce material changes to the devices.
The affected products include syringes manufactured by Becton Dickinson and Monoject, identified by catalog numbers 405-560BD and 405-560MJ. Specific lot numbers involved in the recall are 3650-23508, 3650-24116, 3650-24332, 3650-24399, 3650-24487, 3650-24519, 3650-23478, 3650-23971, 3630-23509, 3630-23972, 3630-24181, 3630-24333, 3630-24397, 3630-24488, and 3630-24152. The devices were distributed nationwide and in Switzerland.
Healthcare facilities and consumers should check their inventory for these specific catalog and lot numbers. If the affected devices are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
- Manufacturer
- Genesis BPS, LLC.
- Affected units
- 7,272
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 (14)
- Cat #405-560BD Lot # 3650-23508
- 3650-24116
- 3650-24332
- 3650-24399
- 3650-24487
- 3650-24519
- 3650-23478
- 3650-23971 Cat # 405-560MJ Lot #3630-23509
- 3630-23972
- 3630-24181
- 3630-24333
- 3630-24397
- 3630-24488
- 3630-24152
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Genesis BPS, LLC. 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 3 products in this recall →Related recalls
Same manufacturer · Genesis BPS, LLC.
See all →- ModerateGenesis BPS Recalls Pediatric Blood Filter Syringes for Regulatory Non-Compliance
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