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CriticalFDA
Draeger, Inc.
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The At...
Respiratory Devices·530 affected·Sep 9, 2025
High RiskFDA
Biopro, Inc.
BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR H...
Medical Devices·147 affected·Sep 9, 2025
High RiskFDA
Biopro, Inc.
BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 185...
Medical Devices·147 affected·Sep 9, 2025
CriticalFDA
Draeger, Inc.
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The ...
Respiratory Devices·223 affected·Sep 9, 2025
High RiskFDA
Biomet, Inc.
Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080
Medical Devices·40 affected·Sep 9, 2025
CriticalFDA
Lee K Of Ny Inc.
PINOCCHIO CATERING Aged Kimchi Mackerel; 57oz; 27330700000 in black bottomed plastic container
Food·43 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
Medical Devices·8,475 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
Medical Devices·2,000 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
Medical Devices·2,000 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemosafeLock Connecter REF: KL-FNU3
Medical Devices·134,700 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
Medical Devices·900 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20
Medical Devices·80 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
Medical Devices·2,100 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
Medical Devices·950 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
Medical Devices·6,450 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011
Medical Devices·11,000 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
Medical Devices·202,900 affected·Sep 8, 2025
High RiskFDA
Beckman Coulter, Inc.
CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD an...
Medical Devices·108 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
Medical Devices·600 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: ...
Medical Devices·7,950 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
Medical Devices·53,050 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
Medical Devices·1,700 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
Medical Devices·200 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemoLock Port REF: CL2100
Medical Devices·133,255 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clam...
Medical Devices·200 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
Medical Devices·4,000 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
Medical Devices·134,700 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rota...
Medical Devices·950 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemoLock Bag Spike REF: CL-10
Medical Devices·7,850 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
Medical Devices·150 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemoLock Closed Vial Spike REF: CL-80
Medical Devices·6,150 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
Medical Devices·2,450 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
Medical Devices·11,000 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
Medical Devices·3,350 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
Medical Devices·1,600 affected·Sep 8, 2025
High RiskFDA
Iantrek Inc.
C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Gon...
Surgical Devices·198 affected·Sep 6, 2025
High RiskFDA
Iantrek Inc.
Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodi...
Surgical Devices·1,262 affected·Sep 6, 2025
CriticalFDA
Chetak New York Llc
Deep-brand Select Bhindi Cut Okra KEEP FROZEN a) Net Wt. 12 oz (340 g); b) Net Wt. 1 LB 8 oz. (24 oz.) (680 g); c) Net Wt. 2 LB (907 g)
Frozen Food·3,509,532 affected·Sep 5, 2025
CriticalFDA
Chetak New York Llc
Deep-brand PREMIUM Select Peas and Carrots KEEP FROZEN Net Wt. 2 LB (907 g)
Frozen Food·3,509,532 affected·Sep 5, 2025
CriticalFDA
Chetak New York Llc
Deep-brand Indian Kitchen Quick Cubes Ready For Cooking Green Chili of India Net Wt. 10 oz. (283 g) KEEP FROZEN
Frozen Food·3,509,532 affected·Sep 5, 2025
CriticalFDA
Chetak New York Llc
Deep-brand PREMIUM Select Mixed Vegetables 4 way KEEP FROZEN a) Net Wt. 3.85 LB. (1.75 kg); b) Net Wt. 2 LB (907 g)
Produce·3,509,532 affected·Sep 5, 2025
CriticalFDA
Chetak New York Llc
Deep-brand Premium Select Baby Bhindi KEEP FROZEN Net Wt. 12 oz (340 g)
Frozen Food·3,509,532 affected·Sep 5, 2025
CriticalFDA
Chetak New York Llc
Deep-brand PREMIUM Select Tapioca (Cassava) Diced KEEP FROZEN Net Wt. 12 oz. (340 g)
Frozen Food·3,509,532 affected·Sep 5, 2025
CriticalFDA
Chetak New York Llc
Deep-brand PREMIUM Select Sweet Corn KEEP FROZEN Net Wt. 2 LB (907 g)
Frozen Food·3,509,532 affected·Sep 5, 2025
CriticalFDA
Chetak New York Llc
Deep-brand PREMIUM Select Garlic Cloves Net Wt. 12 oz. (340 g) KEEP FROZEN
Frozen Food·3,509,532 affected·Sep 5, 2025
CriticalFDA
Chetak New York Llc
Deep-brand Indian Kitchen Quick Cubes READY FOR COOKING Garlic of India KEEP FROZEN Net Wt. 10 oz. (283 g)
Frozen Food·3,509,532 affected·Sep 5, 2025
CriticalFDA
Chetak New York Llc
Deep-brand PREMIUM Select Falsa KEEP FROZEN Net Wt. 12 oz. (340 g)
Frozen Food·3,509,532 affected·Sep 5, 2025
CriticalFDA
Chetak New York Llc
Deep-brand Select Tindora Net Wt. 12 oz. (340 g) KEEP FROZEN
Frozen Food·3,509,532 affected·Sep 5, 2025