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

1201–1225 of 13389

HighFDA (Devices)·Z-1052-2026·2026-01-21
[pending] Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
Pending LLM rewrite. Source: FDA_DEVICE Z-1052-2026.
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-LE FORT MANDIBLE PACK-LF, Medline Kit SKU DYNJ0785864R; 2) RR-ASC EAR PACK-LF, Medline Kit SKU DYNJ0792607R.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1022-2026·2026-01-21
[pending] FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus s
Pending LLM rewrite. Source: FDA_DEVICE Z-1022-2026.
Product
FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Category
Medical Device
Distribution
36 states
HighFDA (Devices)·Z-1082-2026·2026-01-21
[pending] Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5
Pending LLM rewrite. Source: FDA_DEVICE Z-1082-2026.
Product
Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suita
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1023-2026·2026-01-21
[pending] FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus s
Pending LLM rewrite. Source: FDA_DEVICE Z-1023-2026.
Product
FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Category
Medical Device
Distribution
36 states
HighFDA (Devices)·Z-1073-2026·2026-01-21
[pending] Allura Xper FD10; Model Number: 722026;
Pending LLM rewrite. Source: FDA_DEVICE Z-1073-2026.
Product
Allura Xper FD10; Model Number: 722026;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1066-2026·2026-01-21
[pending] Allura Xper FD20; Model Number: 722006;
Pending LLM rewrite. Source: FDA_DEVICE Z-1066-2026.
Product
Allura Xper FD20; Model Number: 722006;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1088-2026·2026-01-21
[pending] Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC G
Pending LLM rewrite. Source: FDA_DEVICE Z-1088-2026.
Product
Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC GYN, REF CDS980647K; 3) DAVINCI PROCEDURE, REF CDS980864Q; 4) GYN-URO LAPSCP CDS-LF, REF CDS981583U; 5) GYN-URO LAPSCP CDS-LF, REF CDS981583V; 6) GYN ROBOTIC, REF CDS981826K
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0998-2026·2026-01-14
[pending] The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track th
Pending LLM rewrite. Source: FDA_DEVICE Z-0998-2026.
Product
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1036-2026·2026-01-14
[pending] Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit
Pending LLM rewrite. Source: FDA_DEVICE Z-1036-2026.
Product
Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1029-2026·2026-01-14
[pending] The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Pending LLM rewrite. Source: FDA_DEVICE Z-1029-2026.
Product
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1003-2026·2026-01-14
[pending] Philips Incisive CT
Pending LLM rewrite. Source: FDA_DEVICE Z-1003-2026.
Product
Philips Incisive CT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1028-2026·2026-01-14
[pending] BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 13
Pending LLM rewrite. Source: FDA_DEVICE Z-1028-2026.
Product
BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1010-2026·2026-01-14
[pending] Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Pending LLM rewrite. Source: FDA_DEVICE Z-1010-2026.
Product
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1035-2026·2026-01-14
[pending] Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONL
Pending LLM rewrite. Source: FDA_DEVICE Z-1035-2026.
Product
Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC; HUD1042 O2 MASK,MED CONC,PEDI,7' TUB SC; HUD1930 O2 MASK,MED CONC,ADULT,7' TUB UC; HUDRHO41U MASK,OXYGEN,MEDIUM-CONCENTRAT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1025-2026·2026-01-14
[pending] Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin
Pending LLM rewrite. Source: FDA_DEVICE Z-1025-2026.
Product
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1026-2026·2026-01-14
[pending] Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method,
Pending LLM rewrite. Source: FDA_DEVICE Z-1026-2026.
Product
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1001-2026·2026-01-14
[pending] Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Pending LLM rewrite. Source: FDA_DEVICE Z-1001-2026.
Product
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1000-2026·2026-01-14
[pending] Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
Pending LLM rewrite. Source: FDA_DEVICE Z-1000-2026.
Product
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1034-2026·2026-01-14
[pending] Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119
Pending LLM rewrite. Source: FDA_DEVICE Z-1034-2026.
Product
Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1019-2026·2026-01-14
[pending] Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Cata
Pending LLM rewrite. Source: FDA_DEVICE Z-1019-2026.
Product
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1027-2026·2026-01-14
[pending] Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-
Pending LLM rewrite. Source: FDA_DEVICE Z-1027-2026.
Product
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: 01-2017. Used with User/Operator Manual
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0999-2026·2026-01-14
[pending] LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Pending LLM rewrite. Source: FDA_DEVICE Z-0999-2026.
Product
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1002-2026·2026-01-14
[pending] Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Pending LLM rewrite. Source: FDA_DEVICE Z-1002-2026.
Product
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1009-2026·2026-01-14
[pending] The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated m
Pending LLM rewrite. Source: FDA_DEVICE Z-1009-2026.
Product
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocompl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1030-2026·2026-01-14
[pending] Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Pending LLM rewrite. Source: FDA_DEVICE Z-1030-2026.
Product
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Category
Medical Device
Distribution
0 states

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1201–1225 of 13389