The Recall Desk

State

New York product recalls

73,219 recalls have nationwide distribution and so reach New York. 12,939 additional recalls listed New York specifically in their distribution scope.

What the numbers show

Total
12,939
Critical
1,511
Severe
3,148
Most recent
2026-09-30

Of the 12,939 recalls naming New York we have scored against our rubric, 1,511 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3,148 (24%) are Severe.

These figures cover only the 12,939 recalls whose distribution notice names New York specifically. The 73,219 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

16776–16800 of 86158

  • CriticalFDA (Devices)·Z-2217-2023·2023-08-02

    Datascope SENSATION 7 Intra-Aortic Balloon Catheters Recalled for Introducer Fracture Risk

    The SENSATION 7 Fr. intra-aortic balloon catheter introducer dilator may fracture during insertion, potentially damaging blood vessels and requiring surgery. One death has been reported among 10 total complaints.

    Product
    SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2224-2023·2023-08-02

    Intra-Aortic Balloon Catheter Introducer Set fracture causes vascular injury

    Datascope Corp. recalls Reinforced Introducer Sets because the dilator may fracture during catheter insertion, risking arterial damage and embolization. One patient death has been reported.

    Product
    REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number REINFORCED INTRODUCER…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2221-2023·2023-08-02

    Datascope SENSATION PLUS Intra-Aortic Balloon Catheter Dilator Fracture Risk

    Datascope's SENSATION PLUS intra-aortic balloon catheter dilator may fracture during insertion, potentially damaging the femoral artery or aorta. The firm has received 10 complaints, including 3 serious adverse events and 1 patient death.

    Product
    SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 7.5Fr.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2219-2023·2023-08-02

    Intra-Aortic Balloon Catheter kits recalled due to dilator fracture risk

    Datascope's MEGA 7.5Fr. intra-aortic balloon catheter kits may have introducers that fracture during insertion, risking arterial damage and embolization. The firm has received 10 complaints including 3 serious events and 1 death.

    Product
    MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 7.5Fr. 40cc IAB WITH…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2218-2023·2023-08-02

    Intra-Aortic Balloon Catheter Introducer Dilator May Fracture During Insertion

    Datascope TRANS-RAY IAB catheters may have introducer dilators that fracture during insertion, risking arterial damage or blood clots. The firm reports 1 death and 3 serious injuries.

    Product
    TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number 7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES D684-00-0545-01 TRANS-RAY 7FR.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2222-2023·2023-08-02

    Intra-aortic balloon catheter recall due to introducer dilator fracture risk

    Datascope Corp. is recalling SENSATION PLUS 8Fr. intra-aortic balloon catheters because the introducer dilator may fracture during insertion, risking blood vessel damage and surgical intervention. The company received 10 complaints, including 1 death.

    Product
    SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 8Fr. 50cc…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2142-2023·2023-08-02

    Hamilton C3 ventilator software anomaly may cause unexpected device stoppage

    A software anomaly in the Hamilton C3 Ventilator may cause it to unexpectedly stop and enter ambient mode without warning after approximately 91 days of use. Approximately 701 systems are affected.

    Product
    HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
    Category
    Medical Device
    Distribution
    50 states
  • SevereFDA (Devices)·Z-2140-2023·2023-08-02

    HAMILTON T1 Ventilator software defect may cause unexpected shutdown

    Hamilton Medical is recalling 2,319 HAMILTON T1 Ventilators due to a software anomaly that may cause the device to stop and enter ambient mode after approximately 91 days of use.

    Product
    HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
    Category
    Medical Device
    Distribution
    50 states
  • SevereFDA (Devices)·Z-2139-2023·2023-08-02

    HAMILTON C1 Ventilator Recalled for Software Defect Causing Unexpected Shutdown

    Hamilton Medical is recalling 689 HAMILTON C1 Ventilators due to a software defect that causes unexpected shutdown after approximately 91 days of use. The device may enter ambient mode without notice, interrupting ventilatory support.

    Product
    HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
    Category
    Medical Device
    Distribution
    50 states
  • SevereFDA (Devices)·Z-2141-2023·2023-08-02

    Hamilton C2 Ventilator recalled for software anomaly causing loss of function

    FDA is recalling 399 Hamilton C2 Ventilators due to a software anomaly that may cause the device to stop unexpectedly after approximately 91 days of use. Affected facilities should verify serial numbers and contact the manufacturer.

    Product
    HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-2228-2023·2023-08-02

    Flexiva Pulse 242 Laser Fibers Recalled Due to Overheating Risk

    Boston Scientific is recalling Flexiva Pulse 242 Single-Use Laser Fibers due to manufacturing defects that reduce power output and aiming beam visibility, risking fiber connector overheating and potential burns.

    Product
    Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Single-pack UPN : M006L8405910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2236-2023·2023-08-02

    Trexo Device recalled due to electrical hazards and burn risk

    Trexo Robotics is recalling the Trexo Device due to electrical issues that could cause burns, device malfunction, and electromagnetic interference with other equipment. Consumers should stop using affected devices.

    Product
    Trexo Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0940-2023·2023-08-02

    Methylphenidate Hydrochloride Tablets Recalled Due to Metal Contamination

    Sun Pharmaceutical Industries is recalling 7,313 bottles of Methylphenidate Hydrochloride Tablets (20mg) due to metal embedded in some tablets. No illnesses have been reported.

    Product
    METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2232-2023·2023-08-02

    Flexiva Pulse ID Laser Fiber Recalled for Potential Burn Hazard

    Boston Scientific recalls Flexiva Pulse ID laser fibers used in urological procedures due to a manufacturing defect that may cause connector overheating and burns. The recall affects 205 units distributed in the US and Canada.

    Product
    Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Box of 5)UPN: M006L8406911
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2229-2023·2023-08-02

    Flexiva Pulse 242 Laser Fibers Recalled Due to Overheating Risk

    Boston Scientific's Flexiva Pulse 242 TracTip laser fibers may overheat during use due to a manufacturing defect, posing a burn risk. Affected units should not be used.

    Product
    Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN : M006L8405960
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0943-2023·2023-08-02

    Safe Tussin PM Night Time Cough Relief Recalled for Manufacturing Deviation

    Kramer Laboratories is recalling Safe Tussin PM Night Time Cough Relief due to use of non-food-grade lubricant in the mixing vessel during manufacturing. Affected product: lot 8639, expiration 8/2023, distributed nationwide.

    Product
    Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2238-2023·2023-08-02

    FRED Flow Re-Direction Endoluminal Device recalled for incorrect inner stent length

    The FDA is recalling FRED Flow Re-Direction Endoluminal Devices due to a manufacturing defect that may result in incorrect inner stent length, potentially affecting device performance. 474 units were affected.

    Product
    FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, FRED3524-PMA, FRED3536-CA, FRED3536-PMA, FRED4007-PMA, FRED4012-CA, FRED4012-PMA, FRED4017-PMA, FRED4026, FRED4026-PMA, FRED4038-PMA, FRED4508…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1292-2023·2023-08-02

    Spring Valley Potato Blintzes Recalled for Undeclared Milk

    Spring Valley Potato Blintzes are being recalled because they contain undeclared milk. Consumers with milk allergies face health risks if they consume this product.

    Product
    SPRING VALLEY brand POTATO BLINTZES; NET WT. 13 OZ (369g); KEEP FROZEN; READY TO COOK; INGREDIENTS: WHEAT FLOUR (WHET FLOUR, NIACIN, REDUCED IRON, THIAMIN MONONITRATE, RIBOFLAVEN, ENZYME, FOLIC ACID), WATER, POTATOES, EGG, ONIONS, CANOLA OIL, EGG WHITES, DEXTROSE, CORN STARCH…
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2244-2023·2023-08-02

    Surgical mesh inflation malfunction in Ventralight ST hernia repair device

    Davol's Ventralight ST surgical mesh may fail to inflate properly during laparoscopic hernia repair, potentially causing inadequate mesh placement and infection.

    Product
    Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955460G (EU…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2240-2023·2023-08-02

    Mobile X-ray System with Faulty Glue Assembly May Pose Electric Shock Hazard

    Siemens Mobile X-ray systems may have incorrect glue on the tank cover assembly, which could fall off and allow liquid ingress, creating electric shock risk. The recall affects 9 units distributed in the US and internationally.

    Product
    Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. Material #11515088
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2235-2023·2023-08-02

    vRad PACS medical imaging system recalled for intermittent image display failures

    Virtual Radiologic's vRad PACS with Mammography system may intermittently fail to display radiology images, preventing radiologists from viewing diagnostic studies. Eight units across seven U.S. states are affected by this Class II recall.

    Product
    vRad PACS with Mammography
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2233-2023·2023-08-02

    Flexiva Pulse Laser Fiber Recalled Due to Burn Hazard from Incorrect Component

    Boston Scientific is recalling Flexiva Pulse 242 ID Trac laser fibers with incorrect components that may overheat and cause burns if touched during use.

    Product
    Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Single-pack UPN): M006L8406960
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0937-2023·2023-08-02

    Oxacillin for Injection Recalled Nationwide for Lack of Sterility Assurance

    Sagent Pharmaceuticals is recalling Oxacillin for Injection due to lack of assurance of sterility. The product was distributed to healthcare facilities nationwide.

    Product
    Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2241-2023·2023-08-02

    Hernia repair implant balloon may not inflate as intended

    Davol's Ventralight ST hernia repair implant balloon may fail to inflate properly during laparoscopic surgery. This could result in procedure delay, inadequate mesh placement, and risk of infection.

    Product
    Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
    Category
    Medical Device
    Distribution
    Distributed nationwide