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.

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6426–6450 of 40007

  • ModerateFDA (Devices)·Z-2713-2024·2024-08-28

    Medline Medical Procedure Kits Recalled for Dimensional Variation Affecting Outer Canister Fit

    Medline Industries is recalling certain C-Section surgical kits due to dimensional variations that could cause difficulty fitting into the outer canister. The recall affects 1,753 units distributed worldwide.

    Product
    Medline medical procedure kits labeled as follows: a) C-SECTION CDS, REF CDS983998C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2709-2024·2024-08-28

    Medline medical procedure kits recalled due to dimensional variation

    Medline Industries is recalling 1,700 medical procedure kits due to a dimensional variation that may cause fitting difficulty into the outer canister. The affected kits were distributed in the US and internationally.

    Product
    Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM2169
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2691-2024·2024-08-28

    Clinical Chemistry Analyzer Software Issue Causes Delayed Results

    Beckman Coulter clinical chemistry analyzers have a software issue that delays diagnostic results after processing 250 racks. Affected units experience buffer errors and result delays.

    Product
    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2702-2024·2024-08-28

    Medline Dental Procedure Kits Recalled Due to Dimensional Variation

    Medline Industries is recalling certain dental procedure kits due to dimensional variations that may cause difficulty fitting into the outer canister. The recall affects 99 units distributed worldwide.

    Product
    Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2700-2024·2024-08-28

    Medline Anesthesia Circuit Kits Recalled for Dimensional Variation

    Medline is recalling three models of anesthesia circuit kits due to slight dimensional variations that may cause difficulty fitting into the outer canister. The recall affects 1920 units distributed worldwide.

    Product
    Medline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT ADULT, REF DYNJAAF6666B; b) ANESTHESIA CIRCUIT PEDS-LF, REF DYNJAP9918A; c) CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2704-2024·2024-08-28

    Medline Medical Procedure Kits Recalled for Canister Fitting Issues

    Medline is recalling 22,891 medical procedure kits because of a slight dimensional variation that may cause difficulty fitting into the outer canister.

    Product
    Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDOSCOPY KIT, REF DYKE1431B; d) ENDOSCOPY KIT, REF DYKE1623B; e) GENERAL LAPAROSCOPY, REF DYNJ902385I; f) GENERAL LAPAROSCOPY, REF DYNJ905508G; g) GENERAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2687-2024·2024-08-28

    Dental Digital Analog Products Recalled for Out-of-Specification Rotation

    Preat Corp is recalling 185 dental digital analog products due to out-of-specification rotation affecting inspection accuracy. The devices are used in dental laboratories for visual inspection of abutments and restorations.

    Product
    Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303 3i Certain-compatible 5.0mm Digital Analog, REF 9001903 3i Certain-compatible 6.0mm Digital Analog,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2699-2024·2024-08-28

    Medical Device Liner Recalled for Dimensional Variation Affecting Fit

    Medline Industries has recalled 316,125 units of its MED-SOFT Single Liner with Solidifier due to a dimensional variation that may cause difficulty when inserting the product into the outer canister.

    Product
    1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2714-2024·2024-08-28

    Medline Surgical Procedure Kits Recalled for Dimensional Fit Issue

    Medline is recalling 14,977 surgical procedure kits due to dimensional variations that may cause difficulty fitting into the outer canister.

    Product
    Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYNJ909699; b) BACK CDS, REF CDS984000C; c) EXTREMITY, REF DYNJ900847A; d) HAND-LF, REF DYNJ902619G; e) HIP PINNING CDS, REF CDS984009C; f) HIP PINNING/TFN/ANTERIOR HIP, REF DYNJ902380K; g) KNEE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2447-2024·2024-08-21

    Plum 360 Infusion Battery Recall Due to Manufacturing Defect

    ICU Medical is recalling Plum 360 Infusion System replacement batteries due to a manufacturing defect that may cause loss of capacity and decreased runtime earlier than expected. Approximately 11,961 units were distributed worldwide.

    Product
    Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following descriptions: Bomba de infusi¿n Plum 360 compatible con el software ICU Medical MedNet, Plum 360 Inf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2543-2024·2024-08-21

    RMU-2000 Automated Chest Compression Device Recalled Due to Motor Failure

    Defibtech is recalling the RMU-2000 Automated Chest Compression Device because a motor defect may cause the device to stop delivering compressions, potentially delaying critical therapy and resulting in patient injury or death.

    Product
    RMU-2000 Automated Chest Compression Device
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-2448-2024·2024-08-21

    Plum A+ and Plum A+3 Infusion Pump Batteries Recalled for Capacity Loss Defect

    ICU Medical is recalling Plum A+ and Plum A+3 infusion pump batteries due to a manufacturing defect that may cause premature capacity loss and reduced runtime. Approximately 14,744 units were distributed worldwide.

    Product
    Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS units marketed with the following descriptions: Plum A+ Mednet TM Firmware New 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2449-2024·2024-08-21

    Plum 360/A+ Spare Battery Defect Causes Accelerated Capacity Loss

    ICU Medical is recalling 130,826 units of Plum 360/A+ spare batteries due to a manufacturing defect that causes earlier-than-expected battery capacity loss and reduced runtime.

    Product
    Plum 360/A+ spare batteries. Item Number: SUB0000864.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2563-2024·2024-08-21

    Merit Medical convenience kits with syringe quality issues recalled nationwide

    Merit Medical is recalling convenience kits containing syringes with quality issues including leaks and breakage that may pose a risk to patients receiving intravenous fluid administration.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2544-2024·2024-08-21

    Beckman Coulter DxI 9000 Access analyzer software causes delayed test results

    Beckman Coulter has recalled 183 DxI 9000 Access analyzers due to a software issue that causes delays in test result reporting. When connected to a Laboratory Automation System, software versions 1.17 and below send out-of-sequence messages, potentially delaying patient treatment.

    Product
    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2621-2024·2024-08-21

    Surgical Lighting Equipment Recalled for Cracked Welds and Frame Detachment Risk

    Aurora Series surgical light heads are recalled due to cracked welds on the frame. The defects can cause the frame to sag, housing to crack, or the light head to detach.

    Product
    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2565-2024·2024-08-21

    Merit Medical Convenience Kits With Recalled Syringes Pose Quality Defect Risks

    Merit Medical convenience kits containing recalled syringes are subject to a nationwide recall due to quality defects including leaks and breakage that may pose risks to patient health.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10/K10-PI (Custom Waste Management Kit), REF: K10T-05815 K10T-05816 K10-04722C K10-03591KP K10-05530 K10-04291AP K10-04386CP K10T-05227 K10-05120P K10-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2564-2024·2024-08-21

    FDA recalls Merit Medical convenience kits due to defective syringes

    Merit Medical convenience kits containing plastic syringes are recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The affected kits are used for vascular and cardiac procedures.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09/K09T (Custom Manifold Kit), REF: K09-00526L K09-00807AH K09-01467AD K09-01467AF K09-01514U K09-01734L K09-02040C K09-02683F K09-02804B K09-03844F K0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2559-2024·2024-08-21

    Merit Medical catheter extractor kits recalled for syringe quality defects

    Merit Medical is recalling 3,631 catheter extractor convenience kits due to defective syringes with leaks and breakage. The identified quality issues may compromise patient safety during catheter removal.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Outake, REF CET200 and CET300, The Catheter Extractor is a catheter accessory device intended for minimally invasive removal of tunneled long term catheters. T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2560-2024·2024-08-21

    Merit Medical Syringes in Convenience Kits Recalled for Leaks and Breakage

    Merit Medical convenience kits containing plastic syringes are recalled due to leaks, breakage, and quality defects that may pose a risk to patient health. Approximately 3,647 kits were distributed nationwide.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K02 (Custom Syringe Kit), REF: K02-00873A, Inject fluids into, or withdraw fluids from, the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2618-2024·2024-08-21

    Aurora 7 Surgical Light Heads Recalled for Cracked Weld Frames

    DKK Dai-Ichi Shomei is recalling 555 Aurora 7 surgical light heads because frame welds can crack, causing the frame to sag, the housing to crack, or the light head to detach.

    Product
    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2620-2024·2024-08-21

    Surgical light heads may detach due to weld defects

    DKK Dai-Ichi Shomei is recalling 293 Aurora surgical light heads because the frame welds can crack, potentially causing the light head to detach during use. No injuries have been reported.

    Product
    Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2566-2024·2024-08-21

    Merit Medical Pressure Monitoring Kits with Defective Syringes Recalled

    Merit Medical is recalling 69 convenience kits containing defective syringes that may leak or break, potentially risking patient safety during medical procedures. The kits were distributed nationwide.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11 (Custom Pressure Monitoring Kit), REF: K11-00382C To support fluid administration into the body and physiological pressure monitoring. To support various v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2617-2024·2024-08-21

    Spinal Cord Stimulation Devices May Reset During Charging, Causing Transient Therapy Loss

    Boston Scientific spinal cord stimulation implants may reset during routine charging, causing brief loss of therapy. Patients may experience undesired sensations when stimulation restarts, potentially leading to surgical intervention requests.

    Product
    WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
    Category
    Medical Device
    Distribution
    Distributed nationwide