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High RiskFDA
Microbiologics Inc
KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
Medical Devices·86 affected·Dec 2, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Softwa...
Medical Devices·22 affected·Dec 2, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Softwa...
Medical Devices·3 affected·Dec 2, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Softwa...
Medical Devices·11 affected·Dec 2, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Softwa...
Medical Devices·23 affected·Dec 2, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Softwa...
Medical Devices·22 affected·Dec 2, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Softwa...
Medical Devices·23 affected·Dec 2, 2025
High RiskFDA
Microbiologics Inc
KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
Medical Devices·18 affected·Dec 2, 2025
High RiskFDA
Microbiologics Inc
LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Medical Devices·1 affected·Dec 2, 2025
High RiskFDA
Hangzhou Bever Medical Devices Co., Ltd.
BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
Surgical Devices·149,310 affected·Nov 29, 2025
High RiskFDA
Mondelez Global Llc
Ritz Peanut Butter Cracker Sandwiches, Net Wt. 27.6 oz.- 20 Count (20 x 1.38-oz. 6-pack carton)
Dairy·70 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RaySt...
Medical Devices·0 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023...
Medical Devices·119 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, R...
Medical Devices·0 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Descr...
Medical Devices·0 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1...
Medical Devices·22 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: Ray...
Medical Devices·8 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStat...
Medical Devices·10 affected·Nov 28, 2025
High RiskFDA
Baxter Healthcare Corporation
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Medical Devices·585 affected·Nov 28, 2025
High RiskFDA
Golden State Medical Supply Inc.
Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10
Oral Drugs·2,472 affected·Nov 26, 2025
RecallFDA
Somerset Therapeutics Llc
Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somer...
Injectable Drugs·71,310 affected·Nov 26, 2025
RecallFDA
Winder Laboratories, Llc
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC...
Oral Drugs·3,528 affected·Nov 26, 2025
RecallFDA
Somerset Therapeutics Llc
Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset ...
Injectable Drugs·28,660 affected·Nov 26, 2025
RecallFDA
Somerset Therapeutics Llc
Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset T...
Injectable Drugs·52,340 affected·Nov 26, 2025
RecallFDA
Sun Pharmaceutical Industries Inc
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries...
Topical Drugs·0 affected·Nov 26, 2025
High RiskFDA
Medline Industries, Lp
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL PACK, Medline kit ...
Medical Devices·16 affected·Nov 26, 2025
High RiskFDA
Cook Incorporated
Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3...
Medical Devices·7,952 affected·Nov 26, 2025
High RiskFDA
Medline Industries, Lp
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPPLIES, Medline kit...
Respiratory Devices·3,045 affected·Nov 26, 2025
CriticalFDA
Medline Industries, Lp
MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L
Medical Devices·35,694 affected·Nov 26, 2025
CriticalFDA
Medline Industries, Lp
MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO
Medical Devices·22,565 affected·Nov 26, 2025
High RiskFDA
Beckman Coulter, Inc.
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Diagnostic Devices·1,272 affected·Nov 26, 2025
High RiskFDA
Beckman Coulter, Inc.
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Diagnostic Devices·6,457 affected·Nov 26, 2025
CriticalFDA
Medline Industries, Lp
MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) Full Electric Basic Homecare Bed, 4-pack,REF MDR107003E-4.
Medical Devices·138,412 affected·Nov 26, 2025
High RiskFDA
Medline Industries, Lp
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medline kit SKU DYKS1...
Medical Devices·11,173 affected·Nov 26, 2025
High RiskFDA
Medline Industries, Lp
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KIT, Medline SKU DY...
Medical Devices·32 affected·Nov 26, 2025
High RiskFDA
Medline Industries, Lp
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH KIT-LF, Medline Ki...
Medical Devices·10 affected·Nov 26, 2025
CriticalFDA
Medline Industries, Lp
MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LO
Medical Devices·15,581 affected·Nov 26, 2025
High RiskFDA
Remote Diagnostic Technologies Ltd.
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: ...
Medical Devices·7,129 affected·Nov 26, 2025
High RiskFDA
Medline Industries, Lp
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1...
Medical Devices·1,725 affected·Nov 26, 2025
High RiskFDA
Cook Incorporated
R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Access Set is inten...
Diagnostic Devices·23 affected·Nov 26, 2025
CriticalFDA
Medline Industries, Lp
MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L
Medical Devices·13,245 affected·Nov 26, 2025
High RiskFDA
Celebration Herbals Us
Celebration Herbals Senna Leaf Herbal Tea 24 Teabags, net wt. 1.48oz. UPC 628240201829
Beverages·1,226 affected·Nov 25, 2025
High RiskFDA
Imu-tek Animal Health, Incorporated
Imu-Tek Immuno-5 Colostrum Powder 7 oz. Intended Use: Dietary Supplement for People. (Some customers use this for their pets).Packagi...
Supplements·113 affected·Nov 25, 2025
High RiskFDA
Ferndale Laboratories, Inc.
Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive,...
Medical Devices·24,589 affected·Nov 25, 2025
High RiskFDA
Bell Industries Llc
Zen Cleanse Blend herbal tea; .95 oz (27g) pouch; 18 pouches/box UPC: 819005011504
Beverages·66 affected·Nov 24, 2025
High RiskFDA
Gimme Coffee, Inc.
Outer-packaging: gimme! brand Decaf de Agua coffee pods, Net Wt. 4.23 oz, UPC 051497457990, box of 10 pods Inner-packaging/pod packaging...
Beverages·252 affected·Nov 24, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotr...
Oral Drugs·7,389 affected·Nov 24, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotr...
Oral Drugs·3,397 affected·Nov 24, 2025