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

1851–1875 of 13384

HighFDA (Devices)·Z-0320-2026·2025-11-05
[pending] Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiol
Pending LLM rewrite. Source: FDA_DEVICE Z-0320-2026.
Product
Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0386-2026·2025-11-05
[pending] Trial Tampon Box; Model Number: FG-TMP-REF04050504;
Pending LLM rewrite. Source: FDA_DEVICE Z-0386-2026.
Product
Trial Tampon Box; Model Number: FG-TMP-REF04050504;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0318-2026·2025-11-05
[pending] Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Andro
Pending LLM rewrite. Source: FDA_DEVICE Z-0318-2026.
Product
Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexc
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0388-2026·2025-11-05
[pending] Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;
Pending LLM rewrite. Source: FDA_DEVICE Z-0388-2026.
Product
Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0389-2026·2025-11-05
[pending] Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;
Pending LLM rewrite. Source: FDA_DEVICE Z-0389-2026.
Product
Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0369-2026·2025-11-05
[pending] Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
Pending LLM rewrite. Source: FDA_DEVICE Z-0369-2026.
Product
Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0346-2026·2025-11-05
[pending] ICU Medical ChemoLock Closed Vial Spike REF: CL-80
Pending LLM rewrite. Source: FDA_DEVICE Z-0346-2026.
Product
ICU Medical ChemoLock Closed Vial Spike REF: CL-80
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0411-2026·2025-11-05
[pending] MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48
Pending LLM rewrite. Source: FDA_DEVICE Z-0411-2026.
Product
MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0394-2026·2025-11-05
[pending] Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;
Pending LLM rewrite. Source: FDA_DEVICE Z-0394-2026.
Product
Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0398-2026·2025-11-05
[pending] Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;
Pending LLM rewrite. Source: FDA_DEVICE Z-0398-2026.
Product
Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0378-2026·2025-11-05
[pending] Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Pending LLM rewrite. Source: FDA_DEVICE Z-0378-2026.
Product
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0321-2026·2025-11-05
[pending] Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, ima
Pending LLM rewrite. Source: FDA_DEVICE Z-0321-2026.
Product
Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0358-2026·2025-11-05
[pending] ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF
Pending LLM rewrite. Source: FDA_DEVICE Z-0358-2026.
Product
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0344-2026·2025-11-05
[pending] ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
Pending LLM rewrite. Source: FDA_DEVICE Z-0344-2026.
Product
ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0359-2026·2025-11-05
[pending] ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros"
Pending LLM rewrite. Source: FDA_DEVICE Z-0359-2026.
Product
ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0391-2026·2025-11-05
[pending] Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;
Pending LLM rewrite. Source: FDA_DEVICE Z-0391-2026.
Product
Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0361-2026·2025-11-05
[pending] ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer RE
Pending LLM rewrite. Source: FDA_DEVICE Z-0361-2026.
Product
ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0349-2026·2025-11-05
[pending] ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
Pending LLM rewrite. Source: FDA_DEVICE Z-0349-2026.
Product
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0407-2026·2025-11-05
[pending] Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;
Pending LLM rewrite. Source: FDA_DEVICE Z-0407-2026.
Product
Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0340-2026·2025-11-05
[pending] ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red C
Pending LLM rewrite. Source: FDA_DEVICE Z-0340-2026.
Product
ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0163-2026·2025-11-05
[pending] IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
Pending LLM rewrite. Source: FDA_DEVICE Z-0163-2026.
Product
IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0408-2026·2025-11-05
[pending] Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Pending LLM rewrite. Source: FDA_DEVICE Z-0408-2026.
Product
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0401-2026·2025-11-05
[pending] Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;
Pending LLM rewrite. Source: FDA_DEVICE Z-0401-2026.
Product
Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0414-2026·2025-11-05
[pending] Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal
Pending LLM rewrite. Source: FDA_DEVICE Z-0414-2026.
Product
Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0402-2026·2025-11-05
[pending] Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;
Pending LLM rewrite. Source: FDA_DEVICE Z-0402-2026.
Product
Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;
Category
Medical Device
Distribution
Distributed nationwide

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1851–1875 of 13384