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

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1101–1125 of 13390

HighFDA (Devices)·Z-1137-2026·2026-01-28
[pending] Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transfe
Pending LLM rewrite. Source: FDA_DEVICE Z-1137-2026.
Product
Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1104-2026·2026-01-28
[pending] RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Versio
Pending LLM rewrite. Source: FDA_DEVICE Z-1104-2026.
Product
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, RayStation 11B SP2, RayStation 11B SP3, RayStation 11B SPT1. Radiation Therapy Treatment Planning System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1127-2026·2026-01-28
[pending] Merit Medical , Custom Manifold Kit REF: K09-13203A
Pending LLM rewrite. Source: FDA_DEVICE Z-1127-2026.
Product
Merit Medical , Custom Manifold Kit REF: K09-13203A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1125-2026·2026-01-28
[pending] Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Pending LLM rewrite. Source: FDA_DEVICE Z-1125-2026.
Product
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1139-2026·2026-01-28
[pending] Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device wit
Pending LLM rewrite. Source: FDA_DEVICE Z-1139-2026.
Product
Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device with power height adjustment that facilitates the sit-to-stand motion.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1105-2026·2026-01-28
[pending] Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.
Pending LLM rewrite. Source: FDA_DEVICE Z-1105-2026.
Product
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A, RayStation 12A SP1, RayStation 12A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1132-2026·2026-01-28
[pending] Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaf
Pending LLM rewrite. Source: FDA_DEVICE Z-1132-2026.
Product
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: 02.426.691S Product Description: 2 Column Distal Radius Plate - 6 Head, 14 Shaft, Standard Left - 186mm Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1154-2026·2026-01-28
[pending] Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Desc
Pending LLM rewrite. Source: FDA_DEVICE Z-1154-2026.
Product
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and cont
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1103-2026·2026-01-28
[pending] RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RaySta
Pending LLM rewrite. Source: FDA_DEVICE Z-1103-2026.
Product
RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3. Radiation Therapy Treatment Planning System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1143-2026·2026-01-28
[pending] Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description:
Pending LLM rewrite. Source: FDA_DEVICE Z-1143-2026.
Product
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1130-2026·2026-01-28
[pending] Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Vers
Pending LLM rewrite. Source: FDA_DEVICE Z-1130-2026.
Product
Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leaseir MHR Xcell is a surgical laser instrument for use in general and plastic surgery and dermatology, intended for hair removal and treatm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1121-2026·2026-01-28
[pending] SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Pending LLM rewrite. Source: FDA_DEVICE Z-1121-2026.
Product
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1016-2026·2026-01-28
[pending] MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LO
Pending LLM rewrite. Source: FDA_DEVICE Z-1016-2026.
Product
MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LO
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1126-2026·2026-01-28
[pending] Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05
Pending LLM rewrite. Source: FDA_DEVICE Z-1126-2026.
Product
Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1152-2026·2026-01-28
[pending] Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description:
Pending LLM rewrite. Source: FDA_DEVICE Z-1152-2026.
Product
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rat
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1119-2026·2026-01-28
[pending] ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Pending LLM rewrite. Source: FDA_DEVICE Z-1119-2026.
Product
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1012-2026·2026-01-28
[pending] MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L
Pending LLM rewrite. Source: FDA_DEVICE Z-1012-2026.
Product
MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1107-2026·2026-01-28
[pending] Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Ver
Pending LLM rewrite. Source: FDA_DEVICE Z-1107-2026.
Product
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1128-2026·2026-01-28
[pending] Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Pending LLM rewrite. Source: FDA_DEVICE Z-1128-2026.
Product
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1144-2026·2026-01-28
[pending] Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s
Pending LLM rewrite. Source: FDA_DEVICE Z-1144-2026.
Product
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts fo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1133-2026·2026-01-28
[pending] Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTH
Pending LLM rewrite. Source: FDA_DEVICE Z-1133-2026.
Product
Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1136-2026·2026-01-28
[pending] TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number
Pending LLM rewrite. Source: FDA_DEVICE Z-1136-2026.
Product
TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1129-2026·2026-01-28
[pending] Allwell Angioplasty Pack REF: IS-30-B1/B
Pending LLM rewrite. Source: FDA_DEVICE Z-1129-2026.
Product
Allwell Angioplasty Pack REF: IS-30-B1/B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1150-2026·2026-01-28
[pending] Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product De
Pending LLM rewrite. Source: FDA_DEVICE Z-1150-2026.
Product
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring info
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1156-2026·2026-01-28
[pending] Patient Information Center iX; Software Version Number: 4.5.0
Pending LLM rewrite. Source: FDA_DEVICE Z-1156-2026.
Product
Patient Information Center iX; Software Version Number: 4.5.0
Category
Medical Device
Distribution
Distributed nationwide

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1101–1125 of 13390