The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

23451–23475 of 88183

  • ModerateFDA (Devices)·Z-1351-2022·2022-07-20

    Philips LAS-100 Laser System may not operate due to detected hardware failure

    Spectranetics' Philips LAS-100 Laser System (105 units) may fail to start if the device detects an inoperable hardware component during power-up, requiring manual error code clearing before operation.

    Product
    Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-1375-2022·2022-07-20

    Cathcart Hip Ball prosthesis recalled for missing surgical technique specification

    DePuy Orthopaedics is recalling Modular Cathcart Hip Ball prostheses (sizes 41-60mm) because the Instructions for Use and Surgical Technique Guide did not document a +5mm offset specification. Updated guides now clarify this for hemi-hip arthroplasty procedures.

    Product
    MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000, 136345000, 136346000, 136347000, 136348000, 136349000, 136350000, 136351000, 136352000, 136353000, 136354000…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1384-2022·2022-07-20

    Anti-FITC-AP CISH Kit Label Bears Incorrect Expiration Date

    Agilent Technologies is recalling 63 Anti-FITC-AP CISH Accessory Kits due to incorrect expiration dates on substrate vial labels, which may result in the use of expired materials.

    Product
    Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1418-2022·2022-07-20

    AloePro Aloe Vera Dietary Supplement Recalled Nationwide for Product Spoilage

    Premier Research Labs is recalling AloePro Aloe Vera dietary supplement nationwide due to product spoilage visible when opened. Consumers should discontinue use.

    Product
    AloePro Dietary Supplement Made With Organic ALOE VERA LIQUID 16 FL Oz. (475 mL) PREMIER RESEARCH LABS UPC Code: 80773500137 packaged in plastic HDPW bottles
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1402-2022·2022-07-13

    Prairie City Bakery Peanut Butter Chocolate Chip Cakes Recalled for Salmonella

    Prairie City Bakery is recalling Peanut Butter Chocolate Chip Ooey Gooey Butter Cakes due to Salmonella contamination from recalled Jif peanut butter ingredient. Products were distributed to gas stations and convenience stores nationwide.

    Product
    Prairie City Bakery Peanut Butter Chocolate Chip Ooey Gooey Butter Cake 2oz. individual UPC: 7-9788436718-2; 10 individual units per display unit; 6 display units per wholesale case.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1399-2022·2022-07-13

    Giant Eagle Cupcakes Recalled Due to Salmonella Contamination Risk

    Giant Eagle Cupcakes (GE Cupcake 6 Buckeye, 18Oz) recalled due to potential Salmonella contamination from Jiff Peanut Butter. 14 units distributed to Pennsylvania.

    Product
    GE 29765500000 Cupcake 6 Buckeye 18Oz
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-1319-2022·2022-07-13

    Palindrome HSI Chronic Catheter Recalled for Potential Hub Leaking

    Covidien is recalling Palindrome HSI Chronic Catheters due to a potential leaking condition in the catheter hub that may cause unanticipated fluid return during dialysis. Approximately 13,526 units distributed worldwide are affected.

    Product
    Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1312-2022·2022-07-13

    Palindrome Precision Chronic Dialysis Catheter Hub Leak Risk

    Palindrome Precision Chronic Catheters used for dialysis may leak due to a flaw in the hub component, potentially allowing unintended fluid to escape during treatment.

    Product
    Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1388-2022·2022-07-13

    Organic oregano ground recalled due to Salmonella contamination

    OS Holding Inc is recalling Organic Oregano Ground distributed in Arizona, Minnesota, and Wisconsin due to potential Salmonella leeuwarden contamination.

    Product
    Organic Oregano Ground is packed in bulk 35 lbs. cases with food-grade poly bag that is labeled in parts: "OREGONSPICE COMPANY***OG Oregano Ground***Net Wt 35 lb (15.89 kg)***13320 NE Jarrett St.*Portland, Oregon 97230***".
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1277-2022·2022-07-13

    COVID-19 nasopharyngeal sample collection tray recalled due to improper assembly

    American Contract Systems, Inc. recalls 274,400 COVID-19 test kits distributed in Minnesota due to off-site assembly by individuals who may not have been properly trained.

    Product
    Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-1395-2022·2022-07-13

    Giant Eagle Peanut Butter Fudge Bar Cake Recalled for Salmonella Risk

    Giant Eagle is recalling Peanut Butter Fudge Bar Cake made with Jiff Peanut Butter due to potential Salmonella contamination. The affected product was distributed in Pennsylvania.

    Product
    GE 25022900000 Peanut Butter Fudge Bar Cake 22.6 Oz
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1276-2022·2022-07-13

    Clean Catch Urine Kit Recalled Due to Improper Assembly

    American Contract Systems is recalling 274,400 Clean Catch Urine Kits due to improper assembly by potentially untrained individuals. The FDA classified this as a Class I recall.

    Product
    Clean Catch Urine Kit NS 178489, AHMU58A
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-1411-2022·2022-07-13

    Built Bar Banana Cream Pie Puffs Protein Bars Recalled for Potential E. coli Contamination

    Built Brands LLC is recalling approximately 4,196 individual Banana Cream Pie Puffs Protein Bars sold nationwide due to potential Escherichia coli contamination.

    Product
    Built Bar, Banana Cream Pie Puffs Protein Bar, 1.41 oz. (40 g) net wt., packaged in individual wrapper, Built Brands, LLC, 600 E Quality Dr., American Fork, UT 84003. SKU 30000318. Product sold as part of a paperboard 12-count mixed box. Each box contains 4 affected bars. UPC 8…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1175-2022·2022-07-13

    CVS Health Magnesium Citrate Laxative Recalled for Bacterial Contamination

    CVS Health Magnesium Citrate SALINE LAXATIVE Oral Solution (1.745 g, Lemon Flavor, 10 FL OZ) is being recalled due to microbial contamination with Gluconacetobacter Liquefaciens. Approximately 98,958 bottles distributed nationwide are affected.

    Product
    CVS Health Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL), Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 30594 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1318-2022·2022-07-13

    Palindrome SI Chronic Dialysis Catheters Recalled for Hub Leaking Risk

    Covidien is recalling 2,462 units of Palindrome SI Chronic Catheters due to a potential leaking condition in the hub that may cause unanticipated fluid return during treatment.

    Product
    Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1315-2022·2022-07-13

    Palindrome Precision Chronic Dialysis Catheters Risk Fluid Leakage Due to Hub Defect

    Covidien recalls 25,765 Palindrome Precision HSI Chronic Catheters due to a defect in the hub that may cause unintended fluid leakage during dialysis treatment.

    Product
    Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1398-2022·2022-07-13

    Giant Eagle Chocolate Peanut Butter Cake Recalled for Salmonella Risk

    Giant Eagle is recalling chocolate peanut butter iced cakes made with Jiff Peanut Butter due to potential Salmonella contamination. The product was distributed in Pennsylvania.

    Product
    GE 25136000000 Bakery, Cake, Chocolate, Peanut Butter Iced 8Oz 4
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1390-2022·2022-07-13

    GE Mini Chocolate Gob with Peanut Butter Icing Recalled for Salmonella

    Giant Eagle brand mini chocolate gobs with peanut butter icing are being recalled due to potential Salmonella contamination from Jiff peanut butter used in manufacturing. The product was distributed in Pennsylvania.

    Product
    GE Bakery, Gob, Mini, Chocolate, Peanut Butter Icing
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1317-2022·2022-07-13

    Palindrome H Chronic Catheters Recalled for Potential Hub Leaking

    Palindrome H Chronic Catheters are being recalled due to a potential leaking condition in the catheter hub that may result in unanticipated fluid return during hemodialysis treatment. Affected units have been distributed worldwide.

    Product
    Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1316-2022·2022-07-13

    Palindrome Chronic Catheter recalled due to potential hub leakage

    Covidien is recalling Palindrome Chronic Catheters due to a potential leaking condition in the hub that may cause unexpected fluid return during use.

    Product
    Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1396-2022·2022-07-13

    Giant Eagle Peanut Butter Fudge Split Cake Recalled for Potential Salmonella

    Giant Eagle's Peanut Butter Fudge Split Cake, made with Jiff Peanut Butter, is being recalled due to potential Salmonella contamination. The recall affects units distributed in Pennsylvania.

    Product
    GE 25115700000 Bakery, Cake, Peanut Butter Fudge Split 25.6 Oz
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1313-2022·2022-07-13

    Palindrome Precision H Chronic Catheter Recalled for Potential Hub Leakage

    Covidien is recalling certain Palindrome Precision H Chronic Catheters because the hub may leak, causing unexpected fluid to flow back during use. This FDA Class I recall affects 26,675 units distributed globally.

    Product
    Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1320-2022·2022-07-13

    Dialysis Catheters Recalled for Potential Fluid Leakage from Hub Defect

    Covidien is recalling Mahurkar Chronic Carbothane dialysis catheters due to a potential leaking condition in the hub that may cause unanticipated fluid return during use. Approximately 132,443 units distributed worldwide are affected.

    Product
    Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide