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.

176–200 of 21707

ModerateFDA (Devices)·Z-0004-2027·2026-10-07
ASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
ASP Global, LLC. is recalling Expressaire Disposable Tourniquet Cuffs because they are labeled with a 10-year shelf life instead of the correct 5-year validated shelf life.
Product
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 18) WHITE Model/Catalog Number: 553323 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0063-2027·2026-10-07
Recall of MPR Single Use Tourniquet Cuffs Due to Incorrect Expiration Dates
ASP Global is recalling 80 MPR Single Use Tourniquet Cuffs because they are labeled with a 10-year shelf life, but the validated shelf life is 5 years.
Product
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 2 LINE (10) Model/Catalog Number: DT-7112-02Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0065-2027·2026-10-07
ASP Global Recalls MPR Tourniquet Cuffs Due to Incorrect Expiration Dates
ASP Global, LLC. is recalling 180 units of MPR Single Use Tourniquet Cuffs because they are labeled with a 10-year shelf life instead of the correct 5-year validated shelf life.
Product
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 2 LINE (10) Model/Catalog Number: DT-7115-02Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0029-2027·2026-10-07
ASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
ASP Global, LLC. is recalling Expressaire Disposable Tourniquet Cuffs because the products are labeled with a 10-year shelf life, but the correct validated shelf life is 5 years.
Product
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-LINE (CS 18) YELLOW Model/Catalog Number: A70107008 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3317-2026·2026-10-07
Philips MR 7700 Software Upgrade Recalled for Incorrect DTI Data
Philips is recalling 30 MR 7700 software upgrades because they export incorrect diffusion tensor imaging data, preventing accurate nerve fiber mapping.
Product
Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3232-2026·2026-09-30
Philips Achieva 1.5T MRI Systems Recalled for Software Memory Issue
Philips is recalling 387 Achieva 1.5T MRI systems worldwide because a software issue may terminate examinations if manual scan adjustments exceed system memory.
Product
Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283 (Achieva 1.5T Conversion), 4. 781346 (Achieva 1.5 Conversion), 5. 781178 (Achieva 1.5T Initial System);
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3223-2026·2026-09-30
Ventec HomeFill Oxygen System Recalled for Missing Medical Gas Labeling
Ventec Life Systems is recalling 25 HomeFill Oxygen Systems because the cylinders lack required medical gas labeling.
Product
REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3264-2026·2026-09-30
Baxter PRO+ Mattress Recalled for UDI Labeling Error
Baxter Healthcare is recalling six PRO+ 40-inch MRS Surface mattresses due to errors in the Unique Device Identification (UDI) label text.
Product
PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned, Model/Catalog Number: P7924A14
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3253-2026·2026-09-30
Criticare nGenuity Patient Monitor Recalled for Capnography Setup Error
Criticare Technologies is recalling 1,007 nGenuity Patient Monitors because a setup error renders the CO2 monitoring function inoperable, potentially delaying procedures.
Product
nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100EP1-US, CAT 8100EP1R
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3257-2026·2026-09-30
Baxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
Baxter Healthcare is recalling two VOLARA systems because contamination in test equipment may have affected flow rate accuracy. Affected devices were returned and confirmed to meet specifications.
Product
Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, HOMECARE, NORTH AMERICA Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3256-2026·2026-09-30
DeRoyal Myocardial Probe Recall Due to Incorrect Needle Length
DeRoyal Industries is recalling Myocardial Probes that contain an 18mm needle instead of the specified 15mm needle.
Product
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3241-2026·2026-09-30
Philips MR 5300 MRI Scanner Software Recall for Image Reconstruction Failure
Philips is recalling 611 MR 5300 MRI scanners due to a software issue that can terminate examinations during image reconstruction if system memory is exceeded.
Product
MR 5300 Model Number (REF): 1. 782110, 2. 782152;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3238-2026·2026-09-30
Philips Ingenia MRI Software Recall for Memory-Related Scan Termination
Philips is recalling Ingenia 3.0T and 3.0T CX MRI systems because a software issue can terminate examinations during image reconstruction if scan parameters exceed available system memory.
Product
Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3225-2026·2026-09-30
Fresenius CombiSet Hemodialysis Blood Tubing Set Recalled for Handling Review
Fresenius Medical Care is recalling CombiSet Hemodialysis Blood Tubing Sets to ensure treatment preparation and handling steps are performed as instructed.
Product
CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3235-2026·2026-09-30
Philips MRI Software Recall for Image Reconstruction Failure
Philips is recalling 91 MRI systems due to a software issue that can terminate examinations during image reconstruction if specific scan parameters are manually adjusted.
Product
Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T);
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3237-2026·2026-09-30
Philips Ingenia Ambition MRI Software Recall for Memory Limit Issue
Philips is recalling 922 Ingenia Ambition MRI systems due to a software issue that can terminate examinations if system memory is exceeded.
Product
Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 (X), 5. 782109 (X), 6. 782138 (X);
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3248-2026·2026-09-30
CooperVision Recalls Pearle Vision 1 Day Contact Lenses Due to Incorrect Power
CooperVision is recalling specific lots of Pearle Vision 1 Day contact lenses because a small number of lenses have the incorrect power.
Product
Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3222-2026·2026-09-30
Ventec HomeFill Oxygen System Recalled for Missing Medical Gas Labeling
Ventec Life Systems is recalling two HomeFill Oxygen Systems because the cylinders lack required medical gas labeling.
Product
REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3242-2026·2026-09-30
Philips MR 7700 MRI Systems Recalled for Software Issue
Philips is recalling 37 MR 7700 MRI systems due to a software issue that can terminate examinations during image reconstruction.
Product
MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3233-2026·2026-09-30
Philips Achieva 3.0T MRI Software Recall for Memory Limit Issues
Philips is recalling 210 Achieva 3.0T MRI scanners because a software issue can terminate examinations if system memory is exceeded during image reconstruction.
Product
Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3262-2026·2026-09-30
Baxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
Baxter Healthcare is recalling 169 PRO+ MRS Mattresses because UDI label errors may lead to incorrect product identification or use with incompatible bed frames.
Product
PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned, Model/Catalog Number: P3255A08
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3240-2026·2026-09-30
Philips Intera 1.5T MRI Systems Recalled for Software Issue
Philips is recalling 82 Intera 1.5T MRI systems worldwide because a software issue can terminate examinations during image reconstruction if specific scan parameters are manually adjusted.
Product
Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova (781172), 5. Intera 1.5T Achieva Nova-Dual (781173), 6. Intera 1.5T Omni/Stellar (781104), 7. Intera Achieva 1.5T Pulsar (781171);
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3216-2026·2026-09-30
Olympus Endoscopic Balloon Dilator Recalled for Incorrect Inflation Chart Label
Olympus is recalling 305 units of EZDilate Endoscopic Balloon Dilators because the inflation chart label may incorrectly indicate balloon diameters of 18, 19, or 20 mm.
Product
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-3236-2026·2026-09-30
Philips Ingenia MRI Software Recall for Image Reconstruction Failure
Philips is recalling 2,038 Ingenia 1.5T MRI systems worldwide due to a software issue that can terminate examinations during image reconstruction if specific scan parameters are manually adjusted.
Product
Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T), 4. 782101(1.5T), 5. 782115(1.5T), 6. 782140(1.5T), 7. 781261(1.5T CX), 8. 781262(1.5T CX), 9. 781347(1.5T S);
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3263-2026·2026-09-30
Baxter PRO+ 36-inch Mattress Recalled for UDI Labeling Error
Baxter Healthcare is recalling 824 PRO+ 36-inch MRS Surface mattresses due to errors in the Unique Device Identification (UDI) label. The discrepancies may lead to incorrect product identification or use with incompatible bed frames.
Product
PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned, Model/Catalog Number: P7924A13
Category
Medical Device
Distribution
Distributed nationwide