Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

1126–1150 of 21710

ModerateFDA (Devices)·Z-1134-2026·2026-01-28
iM series patient monitors recalled over potential cybersecurity issues flagged by FDA
Edan Diagnostics is recalling 14,550 units of its Patient Monitor models iM50, iM60, iM70 and iM80 after an FDA letter raising potential cybersecurity issues with the firm's devices.
Product
Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System…
Category
Medical Device
Distribution
51 states
ModerateFDA (Devices)·Z-1154-2026·2026-01-28
iM8 series patient monitors recalled over potential cybersecurity issues
Edan Diagnostics is recalling 3,141 units of its Patient Monitor models iM8, iM8A and iM8B after an FDA letter raising potential cybersecurity issues with the firm's devices.
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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1143-2026·2026-01-28
iM3 vital signs monitors recalled over potential cybersecurity issues
Edan Diagnostics is recalling 11,987 units of its iM3 Vital Signs Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.
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)…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1152-2026·2026-01-28
M3B vital signs monitors recalled over potential cybersecurity issues
Edan Diagnostics is recalling 354 units of its M3B Vital Signs Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.
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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1156-2026·2026-01-28
Patient information centers recalled over a patch changing notification filters
Philips North America is recalling 146 Patient Information Center iX units because a software patch modifies Mobile Event Notification filter settings without any indication to the user.
Product
Patient Information Center iX; Software Version Number: 4.5.0
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0458-2026·2026-01-28
Cuban crackers recalled over three undeclared artificial colors
Lily's Bakery Factory is recalling 890 boxes of Cuban Crackers Galletas Cubanas over undeclared FD&C Yellow #5, FD&C Yellow #6 and FD&C Red 40.
Product
Cuban Crackers Galletas Cubanas, Net Wt 8Oz (226g). Distributed by Best Floridian, LLC. UPC 5700300060
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-1133-2026·2026-01-28
Reusable hip trial components recalled over missing FDA premarket authorization
MicroPort Orthopedics is recalling 91 units of the HIPTURN 36mm reusable femoral head trial because the product does not have FDA premarket authorization for US distribution.
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
13 states
ModerateFDA (Devices)·Z-1149-2026·2026-01-28
iX series patient monitors recalled over potential cybersecurity issues
Edan Diagnostics is recalling 379 units of its Patient Monitor models iX10, iX12 and iX15 after an FDA letter raising potential cybersecurity issues with the firm's devices.
Product
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1144-2026·2026-01-28
iM3s series vital signs monitors recalled over potential cybersecurity issues
Edan Diagnostics is recalling 136 units of its Vital Signs Monitor models iM3s, iM3As, iM3Bs and iHM3s after an FDA letter raising potential cybersecurity issues with the firm's devices.
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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1131-2026·2026-01-28
Distal radius plates recalled over an incorrect thread orientation
Tyber Medical is recalling 100 VOLT Wrist Treatment System distal radius plates because the supplier manufactured anatomical left plates with an incorrect thread orientation.
Product
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1118-2026·2026-01-28
Plum Duo infusion pumps recalled over blocked piggyback flush programming
ICU Medical is recalling the Plum Duo Infusion Pump because clinicians may receive an Upper or Lower Hard Limit violation message that prevents a piggyback flush from being programmed.
Product
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Category
Medical Device
Distribution
Distributed nationwide
ModerateNHTSA·26V032000·2026-01-22
Blue Bird Recalls 2026-2027 School Buses for Illegible Window Markings
Blue Bird is recalling 2026-2027 Vision and All American school buses because side and rear windows may have illegible DOT markings, failing federal safety standards.
Product
BLUE BIRD — BLUE BIRD ALL AMERICAN SCHOOL BUS, VISION SCHOOL BUS
Category
Vehicle
Distribution
Distributed nationwide
ModerateNHTSA·26V033000·2026-01-22
Blue Bird Recalls One 2026 Vision Transit Bus for Window Markings
Blue Bird is recalling one 2026 Vision transit bus because side or rear windows may have illegible DOT markings, failing federal safety standards.
Product
BLUE BIRD — BLUE BIRD VISION TRANSIT BUS
Category
Vehicle
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1091-2026·2026-01-21
Azurion systems recalled over six identified software issues
Philips Medical Systems Nederland is recalling 10,466 Azurion systems on software versions R2.1.10 and R2.2.10 over six identified software issues including continuous restart.
Product
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1086-2026·2026-01-21
Laparoscopy kits recalled over suction irrigators that can leak during use
Medline is recalling 41,432 laparoscopy convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.
Product
Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOPIC, REF CDS930223M; 3) LAP CHOLE CDS, REF CDS983678K; 4) LAPAROSCOPY PELV CDS, REF CDS983679K; 5) LAP CHOLE CDS-LF, REF CDS983752M; 6) LAP CHOLE…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1070-2026·2026-01-21
Surgical procedure packs recalled over recalled B. Braun administration sets inside
Medline is recalling 338 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.
Product
Allura Xper FD20; Model Number: 722012;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1087-2026·2026-01-21
PALACOS MV bone cement recalled because ampoules may not break
Heraeus Medical is recalling PALACOS MV pro 40 and PALACOS MV pro 80 bone cement because an unfortunate combination of factors can leave ampoules unbroken, so no appropriate cement dough is formed.
Product
Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF; 2) ROBOTIC PROCEDURE, REF CDS982128Q; 3) CUH THORACIC, REF CDS984338M; 4) THORACIC PROCEDURE, REF CDS984640I; 5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O; 6) LAP…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1083-2026·2026-01-21
Procedure kits recalled over suction irrigators that can leak during use
Medline is recalling 4,536 procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.
Product
Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1054-2026·2026-01-21
Facial procedure packs recalled over recalled B. Braun administration sets inside
Medline is recalling 16 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL PACK, Medline kit SKU DYNJ54488A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0260-2026·2026-01-21
Aquarion preserved cartridges recalled over good manufacturing practice deviations
Encon Safety Products is recalling 7,677 bags of AQ 120 GFEW Aquarion Preserved Cartridges over cGMP deviations.
Product
AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1060-2026·2026-01-21
Allura Xper FD10 systems recalled over a missing cooling unit drip tray
Philips Medical Systems Nederland is recalling 56 units of the Allura Xper FD10, model 722010, because the drip tray beneath the cooling unit may not have been installed.
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V; 2) NH PERI DISC PACK, Medline kit SKU DYNJ66311C; 3) DISCECTOMY PACK, Medline kit SKU DYNJ86770; 4) TOTAL…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1076-2026·2026-01-21
Preoperative kits recalled over recalled B. Braun administration sets inside
Medline is recalling 11173 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.
Product
Allura Xper FD20/10; Model Number: 722029;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0256-2026·2026-01-21
Fluocinolone topical solution recalled after failing an impurity specification
Sun Pharmaceutical Industries is recalling 24,624 bottles of Fluocinolone Acetonide Topical Solution 0.01% after an out of specification result for a known impurity.
Product
FLUOCINOLONE ACETONIDE — FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1067-2026·2026-01-21
Allura Xper FD20 Biplane systems recalled over a missing cooling unit drip tray
Philips Medical Systems Nederland is recalling 18 units of the Allura Xper FD20 Biplane, model 722008, because the drip tray beneath the cooling unit may not have been installed.
Product
Allura Xper FD20 Biplane; Model Number: 722008;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1068-2026·2026-01-21
Allura Xper FD10, model 722026, recalled over a missing cooling unit drip tray
Philips Medical Systems Nederland is recalling 95 units of the Allura Xper FD10, model 722026, because the drip tray beneath the cooling unit may not have been installed.
Product
Allura Xper FD10; Model Number: 722010;
Category
Medical Device
Distribution
Distributed nationwide