Calendar

Week of Sep 15, 2025

Sep 17, 2025recall335d agoLannett Company Inc. recall (Cls II)Lannett Co Inc

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100 Tablets per bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-0762-37. — Reason: Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg. — Status: Completed

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Sep 17, 2025recall335d agoThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recall (Cls II)Novel Laboratories Inc

Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-2725-61 — Reason: Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing

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Sep 17, 2025device 510k335d agoThe Tmj Clinic PC — Double Tube Herbst Appliance (510k cleared)

Product code: LRK. Advisory committee: Dental. Type: Abbreviated

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Sep 17, 2025device 510k335d agoManamed, LLC — PlasmaFlow X Compression Sleeve Device (XPF0001) (510k cleared)

Product code: JOW. Advisory committee: Cardiovascular. Type: Special

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Sep 17, 2025device 510k335d agoPegavision Corporation — Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (510k cleared)

Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional

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Sep 17, 2025device 510k335d agoEdwards Lifesciences, LLC — Carpentier-Edwards Physio Annuloplasty Ring (4450) (510k cleared)Edwards Lifesciences Corp

Product code: KRH. Advisory committee: Cardiovascular. Type: Abbreviated

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Sep 17, 2025device 510k335d agoKamemizu Chemical Industry Co., Ltd. — DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White) (510k cleared)

Product code: EBI. Advisory committee: Dental. Type: Traditional

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Sep 17, 2025device 510k335d agoShenzhen Yicai Health Technology Co., Ltd. — Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) (510k cleared)Aimei Health Technology Co., Ltd.

Product code: IRP. Advisory committee: Physical Medicine. Type: Traditional

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Sep 17, 2025device 510k335d agoRuthless, LLC Dba Ruthless Spine — Ruthless Spine RJB (510k cleared)

Product code: QWL. Advisory committee: Orthopedic. Type: Special

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Sep 17, 2025device 510k335d agoAbbott — Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) (510k cleared)

Product code: MXD. Advisory committee: Cardiovascular. Type: Traditional

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Sep 17, 2025device 510k335d agoFujifilm Corporation — ECHELON Synergy (510k cleared)Fujifilm Holdings Corp

Product code: LNH. Advisory committee: Radiology. Type: Traditional

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Sep 17, 2025device 510k335d agoVitacore Industries, Inc. — Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) (510k cleared)

Product code: FXX. Advisory committee: General, Plastic Surgery. Type: Traditional

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Sep 17, 2025device 510k335d agoFull Golden Biotech Co., Ltd. — FG Bone Graft M (510k cleared)

Product code: LYC. Advisory committee: Dental. Type: Traditional

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Sep 17, 2025device pma335d agoABBOTT MEDICAL — Aveir VR Delivery Catheter LSCD111; Aveir DR Delivery Catheter LSCD201 (PMA supplement)

Supplement type: Normal 180 Day Track No User Fee. Product code: PNJ. Advisory committee: CV. Decision: APPR

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Sep 17, 2025device pma335d agoABBOTT MEDICAL — CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM (PMA supplement)

Supplement type: 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: OK30

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Sep 17, 2025device pma335d agoDilon Medical Technologies, Ltd. — MarginProbe (PMA supplement)KESTRA MEDICAL TECHNOLOGIES, LTD.

Supplement type: Normal 180 Day Track. Product code: OEE. Advisory committee: SU. Decision: APPR

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Sep 17, 2025device pma335d agoHowmedica Osteonics Corp. — Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® System (PMA supplement)

Supplement type: 30-Day Notice. Product code: MRA. Advisory committee: OR. Decision: OK30

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Sep 17, 2025device pma335d agoHeartsine Technologies, Ltd. — HeartSine samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories (PMA supplement)TAT TECHNOLOGIES LTD

Supplement type: Real-Time Process. Product code: MKJ. Advisory committee: CV. Decision: APPR

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Sep 17, 2025device recall335d agoBaxter Healthcare Corporation device recall (Cls II)Baxter Healthcare Corp

Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch Allyn SureTemp Plus 692 (01692-200) thermometers — Reason: Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection. — Status: Ongoing

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Sep 17, 2025device recall335d agoCPM Medical Consultants, LLC. device recall (Cls II)

Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS200120L, OS200125, OS200125L, OS200135, OS200324, OS200325, OS200326, OS328026, OS328028C, OS216150, OS218150, OS292110, OS292120, OS292160, OS292200, OS200516, OS200518, OS200520, OS200522, OS200616, OS200618, OS200620, OS200622, OS421300, OS421302, OS421304, OS421306, OS421308, OS421208, OS421210, OS421212, OS421000L, OS421000R, OS421002L, OS421002R, OS421004L, OS421004R, OS421006L, OS421006R, OS42260LL, OS42260LR, OS42260ML, OS42260MR, OS42260SL, OS42260SR, OS42260XSL, OS42260XSR, OS422800, OS422803, OS422804, OS422805, OS422807, OS422825, OS422400, OS422403, OS422404, OS422405, OS422406, OS422407, OS421406, OS421408, OS421414, OS422702, OS422703, OS422712, OS422714, OS422716, OS421512, OS421514, OS421516, OS421112, OS421116, OS421120, OS421124, OS421130, OS42150L, OS42150M, OS42150S, OS42150XS, OS326920-T, OS326922-T, OS326924-T, OS326925, OS326925-T, OS326926-T, OS326928, OS326928-T, OS326930, OS326930-T, OS326932, OS326932-T, OS326934, OS326934-T, OS326936, OS326936-T, OS326938, OS326938-T, OS326940, OS326940-T, OS326945, OS326945-T, OS326950, OS326950-T, OS326955, OS326955-T, OS326960, OS326960-T, OS327920, OS327922, OS327924, OS327926, OS327928, OS327930, OS327932, OS327934, OS327936, OS327938, OS327940, OS327945, OS327950, OS327955, OS327960, OS421710, OS421712, OS421714, OS421716, OS421718, OS421720, OS421722, OS421724, OS421726, OS421728, OS421730, OS421735, OS421740, OS421745, OS421750, OS422508, OS422510, OS422512, OS422514, OS422516, OS422518, OS422520, OS422522, OS422524, OS422526, OS422528, OS422530, OS421814, OS421816, OS421818, OS421820, OS421822, OS421824, OS421826, OS421828, OS421830, OS421835, OS421840, OS421845, OS421850, OS422608, OS422610, OS422612, OS422614, OS422616, OS422618, OS422620, OS422622, OS422624, OS422626, OS422628, OS422630, R327924, R327928, R327932, R327936, R327940, R327945, R327950, R421000L, R421000R, R421710, R421712, R421714, R421716, R421718, R421720, R421722, R421724, R421726, R421728, R421730, R421735, R421740, R421814, R421816, R421818, R421820, R421822, R421824, R421826, R421828, R421830, R421835, R421840, R421845, R421850, R42260ML, R42260MR, R42260SL, R42260SR, R42260XSL, R42260XSR — Reason: Instructions for use for a foot plating system is being updated to remove the second option of requirements for sterilization which was 3 minutes exposure time at 134-137-degrees C (273-279-degrees F) and 40mBar for 5-10 minutes drying time, because these requirements do not apply in the United States. — Status: Ongoing

Sep 17, 2025device recall335d agoPercussionaire Corporation device recall (Cls I)

Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use — Reason: IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure. — Status: Ongoing

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Sep 17, 2025device recall335d agoEnterix, Inc. device recall (Cls II)Anterix Inc.

InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples. — Reason: InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results. — Status: Ongoing

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Sep 17, 2025device recall335d agoELEKTA SOLUTIONS AB device recall (Cls II)

MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3.4 (01)07340201500026(10)3.1.3.4 3.2.1.0 (01)07340201500071(10)3.2.1.0 3.2.1.1 (01)07340201500071(10)3.2.1.1 3.2.1.2 (01)07340201500071(10)3.2.1.2 3.2.1.3 (01)07340201500071(10)3.2.1.3 3.2.1.4 (01)07340201500071(10)3.2.1.4 3.2.2.0 (01)07340201500071(10)3.2.2.0 3.2.2.1 (01)07340201500071(10)3.2.2.1 3.2.3.0 (01)07340201500071(10)3.2.3.0 MOSAIQ¿ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. — Reason: When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule. — Status: Ongoing

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Sep 17, 2025device recall335d agoBeckman Coulter Inc. device recall (Cls II)

SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706 — Reason: Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally and confirmed on August 19, 2025 by Beckman Coulter. — Status: Ongoing

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Sep 17, 2025grant335d agoBOSTON UNIVERSITY MEDICAL CAMPUS — Alcohol taxation, policy environment, and alcohol health services

AA grant. $1,742,166. PI: Ziming Xuan

Week of Sep 15, 2025