Calendar

Week of Sep 22, 2025

Sep 26, 2025device recall341d agoASP Global, LLC. dba Anatomy Supply Partners, LLC. device recall (Cls II)PFIZER INC

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0005 Product Description: A clear, plastic capillary blood collection tube — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing

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Sep 26, 2025device recall341d agoSynthes (USA) Products LLC device recall (Cls II)

LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System. — Reason: Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm. — Status: Ongoing

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Sep 26, 2025device recall341d agoIntegra LifeSciences Corp. (NeuroSciences) device recall (Cls I)INTEGRA LIFESCIENCES HOLDINGS CORP

CODMAN Disposable Perforator 9mm. Cranial Perforator. — Reason: Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution. — Status: Ongoing

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Sep 26, 2025device recall341d agoDSAART LLC device recall (Cls II)

Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UDI-DI code: B4905001065 500-106-6 Pectoral Implant style 1 size 6 right UDI-DI code: B4905001066 500-200-5 Pectoral Implant style 2 size 0 left UDI-DI code: B4950020205 500-200-6 500-201-5 500-201-6 500-202-5 500-202-6 500-403-5 500-403-6 — Reason: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances. — Status: Ongoing

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Sep 26, 2025device recall341d agoASP Global, LLC. dba Anatomy Supply Partners, LLC. device recall (Cls II)

SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004 — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing

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Sep 26, 2025device recall341d agoASP Global, LLC. dba Anatomy Supply Partners, LLC. device recall (Cls II)

AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7220 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing

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Sep 26, 2025device recall341d agoDSAART LLC device recall (Cls II)

Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style 1 size 1 UDI-DI code: B490501101 501-103 - Gluteal Implant style 1 size 3 UDI-DI code: B490501103 501-101 UDI-DI code: B490501101 501-103 - Gluteal Implant style 1 size 3 UDI-DI code: B490501103 501-105 - Gluteal Implant style 1 size 5 UDI-DI code: B490501105 501-206 - Gluteal Implant style 2 size 6 UDI-DI code: B490501206 501-301 - Gluteal Implant style 3 size 1 UDI-DI code: B490501301 501-302 - Gluteal Implant style 3 size 2 UDI-DI code: B490501302 501-303 - Gluteal Implant style 3 size 3 UDI-DI code: B490501303 501-304 - Gluteal Implant style 3 size 4 UDI-DI code: B490501304 501-305 - Gluteal Implant style 3 size 5 UDI-DI code: B490501305 501-306 - Gluteal Implant style 3 size 6 UDI-DI code: B490501306 501-307 - Gluteal Implant style 3 size 7 UDI-DI code: B490501307 501-309 - Gluteal Implant style 3 size 9 UDI-DI code: B490501309 501-310 - Gluteal Implant style 3 size 10 UDI-DI code: B490501310 — Reason: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances. — Status: Ongoing

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Sep 26, 2025device recall341d agoASP Global, LLC. dba Anatomy Supply Partners, LLC. device recall (Cls II)

SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7250 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing

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Sep 26, 2025device recall341d agoASP Global, LLC. dba Anatomy Supply Partners, LLC. device recall (Cls II)

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 0186 Product Description: A clear, plastic capillary blood collection tube coated with Heparin — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing

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Sep 26, 2025grant341d agoUNIVERSITY OF MARYLAND BALTIMORE — Effects of Developmental Alcohol Exposure on Primary and Associative Sensory ...

AA grant. $585,577. PI: Alexandre Esteves Medina

Week of Sep 22, 2025