Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

1826–1850 of 13384

HighFDA (Devices)·Z-0323-2026·2025-11-05
[pending] Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.
Pending LLM rewrite. Source: FDA_DEVICE Z-0323-2026.
Product
Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0333-2026·2025-11-05
[pending] ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, Ch
Pending LLM rewrite. Source: FDA_DEVICE Z-0333-2026.
Product
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: CL3511
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0324-2026·2025-11-05
[pending] SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR
Pending LLM rewrite. Source: FDA_DEVICE Z-0324-2026.
Product
SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0312-2026·2025-11-05
[pending] Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P
Pending LLM rewrite. Source: FDA_DEVICE Z-0312-2026.
Product
Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description: REDUCING CONVERTER 10/12MM TO 5MM Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0410-2026·2025-11-05
[pending] Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC040
Pending LLM rewrite. Source: FDA_DEVICE Z-0410-2026.
Product
Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound device for intraoperative use Component: No
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0347-2026·2025-11-05
[pending] ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
Pending LLM rewrite. Source: FDA_DEVICE Z-0347-2026.
Product
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0352-2026·2025-11-05
[pending] ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
Pending LLM rewrite. Source: FDA_DEVICE Z-0352-2026.
Product
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0331-2026·2025-11-05
[pending] ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
Pending LLM rewrite. Source: FDA_DEVICE Z-0331-2026.
Product
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0368-2026·2025-11-05
[pending] Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 1390
Pending LLM rewrite. Source: FDA_DEVICE Z-0368-2026.
Product
Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-01 139045-01 139046-01 139049-01 139051-01 139052-01 139053-01 139054-01 139055-01 139056-01 139058-01 139059-01 139060-01 139061-0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0372-2026·2025-11-05
[pending] SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 0
Pending LLM rewrite. Source: FDA_DEVICE Z-0372-2026.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Self-sealing Cap, Purple, Model: 07 6013; SAFE-T-FILL Micro Capillary Blood Collection
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0188-2026·2025-11-05
[pending] Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: M
Pending LLM rewrite. Source: FDA_DEVICE Z-0188-2026.
Product
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The Mega Ballast 091 is designed with a semi-rigid proximal shaft and a highly flex
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0350-2026·2025-11-05
[pending] ICU Medical ChemoLock Port REF: CL2100
Pending LLM rewrite. Source: FDA_DEVICE Z-0350-2026.
Product
ICU Medical ChemoLock Port REF: CL2100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0362-2026·2025-11-05
[pending] ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag S
Pending LLM rewrite. Source: FDA_DEVICE Z-0362-2026.
Product
ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0382-2026·2025-11-05
[pending] 18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;
Pending LLM rewrite. Source: FDA_DEVICE Z-0382-2026.
Product
18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0342-2026·2025-11-05
[pending] ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
Pending LLM rewrite. Source: FDA_DEVICE Z-0342-2026.
Product
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0307-2026·2025-11-05
[pending] Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation su
Pending LLM rewrite. Source: FDA_DEVICE Z-0307-2026.
Product
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000252 UNITY 27 GA CHANDELIER 8065000253 UNITY 27+DS WIDE ANGLE LIGHT PROBE Softwa
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0400-2026·2025-11-05
[pending] Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;
Pending LLM rewrite. Source: FDA_DEVICE Z-0400-2026.
Product
Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0336-2026·2025-11-05
[pending] ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
Pending LLM rewrite. Source: FDA_DEVICE Z-0336-2026.
Product
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0363-2026·2025-11-05
[pending] ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
Pending LLM rewrite. Source: FDA_DEVICE Z-0363-2026.
Product
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0405-2026·2025-11-05
[pending] Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;
Pending LLM rewrite. Source: FDA_DEVICE Z-0405-2026.
Product
Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0338-2026·2025-11-05
[pending] ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clam
Pending LLM rewrite. Source: FDA_DEVICE Z-0338-2026.
Product
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, Rotating Luer REF: CL4151
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0375-2026·2025-11-05
[pending] Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1
Pending LLM rewrite. Source: FDA_DEVICE Z-0375-2026.
Product
Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-0341-2026·2025-11-05
[pending] ICU Medical ChemoLock Bag Spike REF: CL-10
Pending LLM rewrite. Source: FDA_DEVICE Z-0341-2026.
Product
ICU Medical ChemoLock Bag Spike REF: CL-10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0306-2026·2025-11-05
[pending] Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation su
Pending LLM rewrite. Source: FDA_DEVICE Z-0306-2026.
Product
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000393 UNITY HP VISCOUS FLUID CONTROL VFC PACK Software Version: N/A Product Descr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0406-2026·2025-11-05
[pending] Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;
Pending LLM rewrite. Source: FDA_DEVICE Z-0406-2026.
Product
Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;
Category
Medical Device
Distribution
Distributed nationwide

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1826–1850 of 13384