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.

901–925 of 21588

ModerateFDA (Devices)·Z-1136-2026·2026-01-28
Laboratory tube sorters recalled over a lift that may drop unexpectedly
Sysmex America is recalling 44 TS-10/TS-10H Tube Sorters because the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement.
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
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
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 VISION SCHOOL BUS, ALL AMERICAN 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-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-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 CHO
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0257-2026·2026-01-21
Clindamycin topical solution recalled after failing impurity and assay specifications
Sun Pharmaceutical Industries is recalling Clindamycin Phosphate Topical Solution 1% after out of specification results for total impurities and for assay.
Product
CLINDAMYCIN PHOSPHATE — CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1069-2026·2026-01-21
Allura Xper FD10/10, model 722011, recalled over a missing drip tray
Philips Medical Systems Nederland is recalling 21 units of the Allura Xper FD10/10, model 722011, because the drip tray beneath the cooling unit may not have been installed.
Product
Allura Xper FD10/10; Model Number: 722011;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1075-2026·2026-01-21
Allura Xper FD20, model 722028, recalled over a missing drip tray
Philips Medical Systems Nederland is recalling 2 Allura Xper FD20 systems because the drip tray beneath the cooling unit may not have been installed.
Product
Allura Xper FD20; Model Number: 722028;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1072-2026·2026-01-21
Allura Xper FD20 OR Table recalled over a missing cooling unit drip tray
Philips Medical Systems Nederland is recalling 4 units of the Allura Xper FD20 OR Table, model 722023, because the drip tray beneath the cooling unit may not have been installed.
Product
Allura Xper FD20 OR Table; Model Number: 722023;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1049-2026·2026-01-21
Allura Xper FD20/10 systems recalled over a missing cooling unit drip tray
Philips Medical Systems Nederland is recalling 4 units of the Allura Xper FD20/10, model 722029, 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: AN01 CAROTID ANESTH KIT-LF, Medline Kit SKU PHS972096014B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1065-2026·2026-01-21
Allura Xper FD10/10, model 722005, recalled over a missing drip tray
Philips Medical Systems Nederland is recalling 14 units of the Allura Xper FD10/10, model 722005, because the drip tray beneath the cooling unit may not have been installed.
Product
Allura Xper FD10/10; Model Number: 722005;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1059-2026·2026-01-21
Neuro angio packs recalled over recalled B. Braun administration sets inside
Medline is recalling 12 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: NEURO ANGIO PACK, Medline kit SKU DYNJ38935
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1089-2026·2026-01-21
Hysterectomy procedure kits recalled over leaking suction irrigators inside
Medline is recalling 1457 units of procedure 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) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F; 4) LAVH, REF DYNJQ9041R; 5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I; 6) ROBOTIC LAVH
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0386-2026·2026-01-21
Strawberry jam recalled over an unapproved colour additive
Mangalm LLC is recalling Tops Strawberry Jam because it contains an unapproved colour, carmoisine.
Product
Tops Strawberry Jam INGREDIENTS: Sugar, Strawberry Pulp 30%, Gelling Agent (Pectin - INS 440), Acidity Regulator (Citric Acid - INS 330), Preservative (Sodium Benzoate - INS 211, Potassium Metabisulphite - INS 224), Food Colour (Carmoisine - INS 122), Nature Identical Flavouring
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-1066-2026·2026-01-21
Allura Xper FD20, model 722006, recalled over a missing drip tray
Philips Medical Systems Nederland is recalling 143 units of the Allura Xper FD20, model 722006, because the drip tray beneath the cooling unit may not have been installed.
Product
Allura Xper FD20; Model Number: 722006;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1064-2026·2026-01-21
Allura Xper FD10, model 722003, recalled over a missing drip tray
Philips Medical Systems Nederland is recalling 93 units of the Allura Xper FD10, model 722003, because the drip tray beneath the cooling unit may not have been installed.
Product
Allura Xper FD10; Model Number: 722003;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0280-2026·2026-01-21
PALACOS MV plus G bone cement recalled because ampoules may not break
Heraeus Medical is recalling PALACOS MV+G pro 40 and PALACOS MV+G pro 80 bone cement because an unfortunate combination of factors can leave ampoules unbroken, so no appropriate cement dough is formed.
Product
Swan, White Clear Alcohol, 50%, 16oz, 12 count
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1090-2026·2026-01-21
Robotic prostate kits recalled over suction irrigators that can leak
Medline is recalling 12 units of procedure 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: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1062-2026·2026-01-21
Allura Xper FD10C systems recalled over a missing cooling unit drip tray
Philips Medical Systems Nederland is recalling 38 Allura Xper FD10C systems because the drip tray beneath the cooling unit may not have been installed.
Product
Product Name: Allura Xper FD10C; Model number: 722001;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1085-2026·2026-01-21
Robotic thoracic and cardiac kits recalled over leaking suction irrigators
Medline is recalling 96 units of procedure 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) THORACIC ROBOTICS, REF DYNJ908777B; 2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1056-2026·2026-01-21
IV start kits recalled over recalled B. Braun administration sets inside
Medline is recalling 5314 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: 1) IV START KIT NS, Medline kit SKU DYKM1980C; 2) (134) L&D IV-START SET, Medline kit SKU DYKM2137B; 3) IV START KIT, Medline kit SKU DYKS1372C; 4) IV START KIT, Medline kit
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1081-2026·2026-01-21
PALACOS R plus G bone cement recalled because ampoules may not break
Heraeus Medical is recalling PALACOS R+G pro 40 and PALACOS R+G pro 80 bone cement because an unfortunate combination of factors can leave ampoules unbroken, so no appropriate cement dough is formed.
Product
Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitabl
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1038-2026·2026-01-21
Universal implant inserters recalled because the rotation tool handle can untread
Medicrea International is recalling 44 IB3D Universal Implant Inserters because, following complaints, the orthopedic rotation tool handle may untread from the shaft.
Product
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1055-2026·2026-01-21
IV supply drawers recalled over recalled B. Braun administration sets inside
Medline is recalling 3045 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: 1) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC010271B; 2) DRAWER 2 IV FLUIDS & TUBING, Medline kit SKU ACC010416B; 3) OXYGENATION & TUBING TRAY, Medline kit SKU ACC010525C; 4)
Category
Medical Device
Distribution
Distributed nationwide