The Recall Desk

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.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Filters

Agency

Category

Minimum severity

Clear filters

51–75 of 27327

  • HighFDA (Devices)·Z-2965-2026·2026-08-26

    Siemens Immulite 2000 Syphilis Screen Recall for Negative Bias

    Siemens Healthineers is recalling 24 units of the Immulite 2000 Syphilis Screen assay due to a potential negative patient bias that may report low reactive results as nonreactive.

    Product
    Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2973-2026·2026-08-26

    Beckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect

    Beckman Coulter is recalling DxC 500i Clinical Analyzer Modules due to a software defect that may cause erroneous patient test results.

    Product
    Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2954-2026·2026-08-26

    Dentsply Sirona Capsule Mixer Recalled for Electrical Discharge Risk

    SDI Limited is recalling 1,444 Dentsply Sirona Capsule Mixers due to a potential for electrical discharge when the unit is unplugged.

    Product
    Dentsply Sirona Capsule Mixer Model No. 5546068
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-2986-2026·2026-08-26

    ConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage

    ConvaTec is recalling Esteem Body Soft Convex Urostomy Pouches because they may leak from the cap during use.

    Product
    Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 423725, 423726, 423727.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2978-2026·2026-08-26

    Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus Recall

    Boston Scientific is recalling ENROUTE Transcarotid Neuroprotection System Plus catheters due to a potential for arterial sheath tip separation during use.

    Product
    Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2990-2026·2026-08-26

    Medicom Recalls Neurological Sponges Due to Endotoxin Variability

    Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile due to potential unexpected variability in endotoxin levels.

    Product
    American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013, Model Item Number MHSP99AF.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2983-2026·2026-08-26

    Fort Defiance Automated Field Steam Sterilizer Recalled for Electrical Grounding Defect

    Fort Defiance Industries is recalling Automated Field Steam Sterilizers because a water recovery system connector may lose ground continuity, creating an unreliable fault current return path.

    Product
    Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2872-2026·2026-08-26

    BD Needle Kit for Powered Driver Recall Due to Removal Difficulty

    Bard Access Systems is recalling BD Needle Kits for Powered Drivers because the obturator may lock to the hub, potentially delaying emergency therapy.

    Product
    BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit for Powered Driver 35mm x 15Ga, REF: D015351NK, BD Needle Kit for Powered Driver 45mm x 15Ga, REF: D015451NK, BD Needle Kit for Powered Dr
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-2958-2026·2026-08-26

    Arrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns

    Arrowhead DE LLC is recalling 4,171 Arrow-LOK Implants because they did not undergo a required gamma radiation dose audit, which could reduce sterility assurance and lead to patient infection.

    Product
    Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540, 21-253545, 21-253550, 21-353513, 21-353516, 27-253519, 27-253522, 27-253525, 27-253528, 27-253530, 27-253533, 27-253535. Implant indicated for fixat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2966-2026·2026-08-26

    Siemens Immulite 2000 Syphilis Screen Recalled for Negative Bias

    Siemens Healthineers is recalling Immulite 2000 Syphilis Screen assays because a negative patient bias may cause low reactive results to be reported as nonreactive.

    Product
    Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2987-2026·2026-08-26

    restor3d Recalls Veritas Standard Glenoid Baseplates Due to Machining Defect

    restor3d Inc. is recalling 59 Veritas Standard Glenoid Baseplates because incorrect machining of peripheral screw holes may cause improper screw engagement.

    Product
    Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-shelf hardware product Product Description: The restor3d Reverse Total Shoulder Arthroplasty System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2952-2026·2026-08-26

    Intersurgical Recalls One-Piece Guedel Airway Devices Due to Occlusion Risk

    Intersurgical Inc is recalling 21,269 One-Piece Guedel Airway devices because they may be occluded or partially occluded. The devices were distributed in six US states.

    Product
    One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2989-2026·2026-08-26

    Medicom Recalls Neurological Sponges Due to Endotoxin Variability

    Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile due to potential unexpected variability in endotoxin levels.

    Product
    American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI; 2) SPINE PACK, Model Item Number HSLM53AC; 3) CRANIAL PACK - 205992, Model Item Number MHCP75AH; 4) IMRI CRANI PACK - 213871, Model Item Number ANCI
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2980-2026·2026-08-26

    Medtronic MiniMed 640G Insulin Pumps Recalled for Chemical Damage Risk

    Medtronic is recalling 16 MiniMed 640G insulin pumps distributed in Europe because chemical cleaning may have damaged the devices, risking incorrect insulin delivery.

    Product
    MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2922-2026·2026-08-19

    Surgipro II Sutures Recalled for Potential Sterile Barrier Defects

    FDA is recalling Surgipro II sutures due to potential sterile packaging defects that could cause biocontamination and infection.

    Product
    Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2938-2026·2026-08-19

    Erbe ERBECRYO 2 Cryosurgical Unit Recalled Due to Rupture Risk

    Erbe USA Inc is recalling ERBECRYO 2 Cryosurgical Units because a strong pull on the high-pressure transfer hose may cause the cryoprobe to rupture.

    Product
    ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2920-2026·2026-08-19

    Dermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects

    Covidien is recalling Dermalon 4-0 sutures because sterile barrier packaging may be perforated or torn, risking biocontamination and infection.

    Product
    Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2873-2026·2026-08-19

    Spectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns

    Spectra Medical Devices is recalling Sodium Chloride Injection ampules because manufacturing issues may have compromised sterility, posing a risk of infection or inflammation to patients.

    Product
    Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2946-2026·2026-08-19

    Cardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges

    Cardinal Health is recalling 602 Presource surgical kits because they contain MEDICOM Ritmed Neurological Sponges with unexpected endotoxin variability.

    Product
    Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE; 3) NEURO MAJOR 2 PACK , Catalog Number: SNE30CRJGY; 4) NEURO PACK , Catalog Number: SNE43
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2918-2026·2026-08-19

    V-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects

    Covidien, LP is recalling V-Loc 90 Absorbable Wound Closure Devices due to potential sterile barrier packaging defects that may cause biocontamination.

    Product
    V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VLOCM0013 V-LOC* 90 4-0 CLR 30CM P12X12 VLOCM0013 VLOCM0024 V-LOC* 90 3-0 CLR 45CM P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2912-2026·2026-08-19

    Microvention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects

    Microvention Inc. is recalling 5,500 Bobby Balloon Guide Catheters worldwide due to an increased rate of balloon pinhole defects.

    Product
    BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2944-2026·2026-08-19

    Cardinal Health Presource Kits Recalled for Endotoxin Variability

    Cardinal Health is recalling Presource Kits containing MEDICOM Ritmed Neurological Sponges due to unexpected variability in endotoxin levels.

    Product
    Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2934-2026·2026-08-19

    Waldemar Link Recalls Endo-Model Tibial Plateau Replacement Sets

    Waldemar Link is recalling Endo-Model tibial plateau replacement sets that incorrectly contain a Pure Hinge plateau, posing a risk of increased wear if implanted.

    Product
    Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
    Category
    Medical Device
    Distribution
    1 state