The Recall Desk

Archive

October 2025 recalls

804 recalls were announced in October 2025.

What the numbers show

Critical
179
Severe
78
High
390
Moderate
154
Low
3

Of the 804 recalls this month scored against our rubric, 22% are Critical, 10% are Severe.

Which agencies issued them

301–400 of 804

  • CriticalFDA (Devices)·Z-0031-2026·2025-10-22

    Percussive ventilation valves recalled over leak risk in small patients

    Percussionaire is recalling 59,160 Phasitron 5 IPV in-line valves whose pressure relief seal may leak when used with a ventilator, and is warning against use in neonates and infants.

    Product
    Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0063-2026·2025-10-22

    BF-Q190 bronchovideoscopes recalled for clarified laser and coagulation instructions

    Olympus is recalling EVIS EXERA III Bronchovideoscope BF-Q190 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0100-2026·2025-10-22

    ALTRUA 2 dual chamber extended life pacemakers recalled for software update

    Boston Scientific is recalling 3,376 ALTRUA 2 DR EL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number S722, ALTRUA 2 DR EL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Food)·H-0049-2026·2025-10-22

    Loose packed large brown eggs recalled over potential Salmonella contamination

    Black Sheep Egg Company is recalling 20,625 dozen Free Range Grade AA Large Brown Eggs loose packed in boxes for potential Salmonella contamination.

    Product
    Free Range Grade AA Large Brown Eggs, Loose Pack in Boxes, 15dz per box, Black Sheep Egg Company 400 S Memorial Drive Walnut Ridge AR 72476
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Devices)·Z-0062-2026·2025-10-22

    BF-Q180-AC bronchovideoscopes recalled for updated laser and coagulation use instructions

    Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type Q180-AC units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V719000·2025-10-22

    Isuzu and Chevrolet axle stabilizer bracket bolts can crack and break

    Isuzu is recalling certain 2018-2026 Isuzu FVR and FTR and Chevrolet 6500XD and 7500XD vehicles because the axle stabilizer bracket bolts may crack and break, letting the bracket detach.

    Product
    ISUZU — ISUZU, CHEVROLET FTR, 6500XD, 7500XD, FVR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0151-2026·2025-10-22

    Ceramic femoral heads recalled over packaging that may compromise sterile barrier

    BioPro is recalling 147 ceramic femoral heads over a potential packaging issue that could compromise the sterile barrier and present a risk of infection if implanted.

    Product
    BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024 HEAD FEMORAL CERAMIC 28MM +0 19025 HEAD FEMORAL CERAMIC 32MM -3 19026 HEAD FEMORAL CERAMIC 32MM +0 19027 HEAD FEMORAL CERAMIC 32MM +3
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0142-2026·2025-10-22

    CX preconnect pumps recalled over inflation and deflation performance issues

    Boston Scientific is recalling 2,288 CX Preconnect devices with TENACIO Pump and InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ), (4) 72404433 (21CM PS IZ), (5) 72404434 (24CM PS IZ), (6) 72404435 (12CM IP IZ), (7) 72404436 (15CM IP IZ), (8) 72404437 (18CM IP IZ), (9)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0177-2026·2025-10-22

    Central line insertion kits recalled after being sterilized more than once

    American Contract Systems is recalling 32,433 adult central line insertion supply kits that were re-gassed after a nonconformance, without validation for multiple sterilization cycles.

    Product
    Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0166-2026·2025-10-22

    Cardiac Workstation 7000 recalled after pinched power module wire caused short

    Philips is recalling 29 Cardiac Workstation 7000 units after environmental stress testing failed because a pinched power module wire inside the housing resulted in a short.

    Product
    Cardiac Workstation 7000; Model Number: 860441;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0201-2026·2025-10-22

    Non-DEHP Continu-Flo sets recalled from one lot because sets may leak

    Baxter is recalling 48,096 CLEARLINK System non-DEHP Continu-Flo solution sets from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0143-2026·2025-10-22

    Preconnect pump devices recalled over inflation and deflation performance issues

    Boston Scientific is recalling 172 CXR Preconnect devices with TENACIO Pump and InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) 72404466 (12CM IP IZ), (7) 72404467 (14CM IP IZ), (8) 72404468 (16CM IP IZ), (9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0182-2026·2025-10-22

    Radiology procedure packs recalled after being sterilized more than once

    American Contract Systems is recalling radiology convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0132-2026·2025-10-22

    Omnipod 5 app recalled because magnifying a field duplicates typed digits

    Insulet is recalling 174,013 units of the Omnipod 5 iOS app because using the iPhone magnifier on a manual entry field while typing can duplicate a digit.

    Product
    The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0192-2026·2025-10-22

    Continu-Flo solution sets recalled across six lots because sets may leak

    Baxter is recalling 473,040 CLEARLINK System Continu-Flo solution sets across six lots because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0135-2026·2025-10-22

    Goniotomy instruments recalled over compromised sterile packaging integrity

    Iantrek is recalling 198 C-Rex UNO Microinterventional Goniotomy Instruments over the potential for compromised integrity of the sterile packaging.

    Product
    C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Goniotomy Instrument is a sterile single use disposable manual surgical instrument used in ophthalmic procedures for ab interno goniotomy and inne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2026·2025-10-22

    Dilation and curettage packs recalled after being sterilized more than once

    American Contract Systems is recalling D and C convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits IHDC30R D AND C PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0145-2026·2025-10-22

    Shoulder surgical planning software recalled over possible implant malalignment risk

    Kico Knee Innovation Company is recalling 21 ARVIS Shoulder systems after a complaint identified an issue with the AI surgical planning software that may cause implant malalignment.

    Product
    Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Product Description: Intended Use: The ARVIS" system is a computer-controlled navigation system intended to provide intra-operative mea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0041-2026·2025-10-22

    Canned pear halves recalled over potential lead contamination in one lot

    Pacific Coast Producers is recalling 1,836 cases of pear halves in pear juice, distributed by Walmart, for potential contamination with lead.

    Product
    Pears Halves in Pear Juice from Concentrate; NET WT 15 OZ (425 g); Ingredients: Pears, Water, Pear Juice Concentrate; Distributed By: Walmart Inc., Bentonville, AR 72716
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0175-2026·2025-10-22

    Cardiac catheterization packs recalled after being sterilized more than once

    American Contract Systems is recalling cardiac catheterization and cath lab convenience packs that were re-gassed after a sterilization nonconformance.

    Product
    Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CARDIAC CATH TRINITY UICC27AG CARDIAC CATH ANGIO PACK (PS 923077) UIRD89AH RADIAL PACK (PS 56573)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0189-2026·2025-10-22

    Stopcock extension solution sets recalled from two lots because sets may leak

    Baxter is recalling 49,200 Continu-Flo solution sets with a 4-way stopcock extension set because the IV sets may leak.

    Product
    CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code 2C6255
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0165-2026·2025-10-22

    Cardiac workstations recalled after pinched power module wire caused short

    Philips is recalling 28 Cardiac Workstation 5000 units after environmental stress testing failed because a pinched power module wire inside the housing resulted in a short.

    Product
    Cardiac Workstation 5000; Model Number: 860439;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0139-2026·2025-10-22

    TENACIO pumps without InhibiZone recalled over inflation and deflation issues

    Boston Scientific is recalling TENACIO Pump without InhibiZone, UPN 72404420, because of the potential for inflation or deflation performance issues or difficulties.

    Product
    TENACIO Pump without InhibiZone; UPN: 72404420;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0133-2026·2025-10-22

    Powered ambulance cots recalled because fastening post hardware could loosen

    Ferno-Washington is recalling 138 Ferno Power X2 powered ambulance cots because the fastening post hardware could loosen, allowing the post to detach from the cot.

    Product
    FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0190-2026·2025-10-22

    Duo-vent solution sets recalled across three lots because sets may leak

    Baxter is recalling 136,512 CLEARLINK System DUO-VENT solution sets across three lots because the IV sets may leak.

    Product
    CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0200-2026·2025-10-22

    Filtered extension sets recalled across two lots because IV sets may leak

    Baxter is recalling 69,936 CLEARLINK System non-DEHP extension sets with a 1.2 micron filter across two lots because the IV sets may leak.

    Product
    CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19-inch (47 centimeters), Product Code 2H8603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0057-2026·2025-10-22

    Frozen bean and rice burritos recalled over potential foreign object contamination

    Amy's Kitchen is recalling 3,238 cases of Gluten Free Bean & Rice Burrito, totaling 38,856 retail units, for potential contamination with foreign objects.

    Product
    Gluten Free Bean & Rice Burrito. 12 retail units per case. 5.5oz/retail unit. UPC code 042272003525. Frozen.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Food)·H-0042-2026·2025-10-22

    Frozen burrito bowl blend recalled because it may contain undeclared shrimp

    One Frozen is recalling 57,240 bags of Good and Gather Southwest-Style Burrito Bowl Blend because the product may contain undeclared shrimp.

    Product
    Good and Gather brand Southwest-Style Burrito Bowl Blend Processed in a facility that also handles shellfish, egg, fish, milk, sesame, soy, tree nut and wheat ingredients
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0036-2026·2025-10-22

    Frozen jumbo shrimp recalled over possible cesium 137 contamination

    Sea Port Products is recalling raw frozen easy peel headless shell-on white shrimp because the shrimp may be contaminated with Cesium-137.

    Product
    Sea Port brand, Raw Frozen Easy Peel Headless Shell-On White Shrimp, Jumbo size 16-20. Product of Indonesia. Distributed by Sea Port Products Corporation, Kirkland, WA. Master Case: 10/2 lbs. bags. Net weight 20lbs. UPC 10659878008617 IQF Inner Bag 2lbs: UPC 6 59878 00861 0 Sea
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·H-0038-2026·2025-10-22

    Canned fruit cocktail recalled over potential lead contamination in one lot

    Pacific Coast Producers is recalling 609 cases of canned fruit cocktail in 100% juice for potential contamination with lead.

    Product
    Fruit Cocktail IN 100% JUICE WITH ADDED INGREDIENTS; NET WT 15 OZ (425 g); Ingredients: Diced Peaches, Diced Pears, Water, Grapes, Peach Pulp and Juice, Pineapple Sectors, Pear Juice Concentrate, Halved Cherries (colored red with Carmine), Ascorbic Acid (to protect color).; Distr
    Category
    Food
    Distribution
    27 states
  • HighFDA (Food)·H-0045-2026·2025-10-22

    Strawberry lemonade pints recalled over potential foreign object contamination

    Wawa Beverage Company is recalling 2,750 units of Wawa Strawberry Lemonade in 16 oz bottles for potential foreign object contamination.

    Product
    Wawa Strawberry Lemonade, 16 oz (Pint), Plastic bottle, Stored refrigerated, UPC: 007626191018982
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·H-0039-2026·2025-10-22

    Canned halved pears recalled over potential lead contamination in one lot

    Pacific Coast Producers is recalling 102 cases of halved pears in pear juice, distributed by Wegmans, for potential contamination with lead.

    Product
    Halved Pears IN PEAR JUICE FROM CONCNETRATE; NET WT 15 OZ (425 g); Ingredients: Pears, Water, Pear Juice Concentrate; Distributed By: Wegmans Food Markets, Inc. Rochester, NY 14603
    Category
    Food
    Distribution
    27 states
  • HighFDA (Food)·H-0134-2026·2025-10-22

    Baby food pouches recalled over potential lead contamination in four lots

    Sprout Organics is recalling 9,873 cases of its Sweet Potato, Apple & Spinach baby food for potential contamination with lead.

    Product
    6+ Months SPROUT ORGANICS Made With Organic Sweet Potato, Apple & Spinach NET WT. 3.5 OZ (99g) INGREDIENTS: ORGANIC SWEET POTATOES, ORGANIC APPLES, ORGANIC SPINACH, WATER, ORGANIC LEMON JUICE. Dist. by Sprout Foods, Inc. Montvale, NJ 07645 UPC: 818512011762
    Category
    Food
    Distribution
    34 states
  • HighFDA (Devices)·Z-0204-2026·2025-10-22

    Non-DEHP solution sets recalled from one lot because IV sets may leak

    Baxter is recalling 18,720 CLEARLINK System non-DEHP Continu-Flo solution sets from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0141-2026·2025-10-22

    LGX preconnect pumps without InhibiZone recalled over inflation deflation issues

    Boston Scientific is recalling LGX Preconnect with TENACIO Pump without InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0171-2026·2025-10-22

    Biopsy and laparoscopy packs recalled after being sterilized more than once

    American Contract Systems is recalling biopsy and laparoscopy convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACK - 205956, ANLP25AJ LAPROSCOPY PACK - 205958, FYLA38E LAPCHOLAPPY PACK, IHDA88AH DIVINCI GYN URO, IHLC11AE LAP GENERAL PACK, MHLP45AJ LAPAROSCOPY PAC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0149-2026·2025-10-22

    Uni-polar endo heads recalled over packaging that may compromise sterility

    BioPro is recalling 147 metal uni-polar Endo Heads over a potential packaging issue that could compromise the sterile barrier and risk infection if implanted.

    Product
    BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181 ENDO MD 43 10182 ENDO MD 45 10183 ENDO MD 47 10184 ENDO MD 49 10185 ENDO MD 51 10186 ENDO MD 53 10187 ENDO MD 55 10188 ENDO SH 38 10189 ENDO SH 41 10190 E
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0158-2026·2025-10-22

    Humidifier devices recalled because power loss alert sounds under two minutes

    Fisher & Paykel is recalling 51,144 Airvo 2 and myAirvo 2 humidifiers because an unintentional power disconnection may sound an audible alert for less than 120 seconds.

    Product
    Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0155-2026·2025-10-22

    Ultrasound systems recalled over inaccurate liver steatosis measurement values

    GE is recalling 65 LOGIQ P10 series systems running software R4.5.7 because the Ultrasound-Guided Attenuation Parameter measurement may display inaccurate liver steatosis values.

    Product
    LOGIQ P10 series with software version R4.5.7 Model Number 5877534
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0160-2026·2025-10-22

    Wound dressings recalled because foreign matter may be on the product

    ConvaTec is recalling 80,980 DuoDERM Extra Thin dressings from one lot because the wound dressing may have foreign matter on the product.

    Product
    DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas subject to friction and those requiring contouring, e.g., elbows, heels. DuoDERM"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0185-2026·2025-10-22

    Eye and cataract packs recalled after being sterilized more than once

    American Contract Systems is recalling cataract, eye, retinal and vitrectomy convenience packs that were re-gassed after a sterilization nonconformance.

    Product
    Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 PERP25AQ PEI RETINAL PACK-206025 RFEY50AC EYE PACK-206026 UIVT47AS VITRECTOMY SUPPLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0167-2026·2025-10-22

    Six foot display cables recalled over inadequate shielding and interference

    Spacelabs Healthcare is recalling 8,179 six-foot DVI display cables because inadequate shielding may allow electromagnetic interference with other electronically sensitive medical devices in use.

    Product
    Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2026·2025-10-22

    Flow diverter devices recalled over tantalum defect affecting vessel wall apposition

    MicroVention is recalling 467 FRED and FRED X flow diverters over a manufacturing issue with tantalum length or attachment that may leave the device incompletely open or poorly apposed.

    Product
    Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827; FRED X 27, REF: XFRED4017-MVE, XFRED4528-MVE, MV-F501427X, XFRED4518-MVE, XFRED5526-MVE, XFRED4539-MVE,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0180-2026·2025-10-22

    Angiography procedure packs recalled after being sterilized more than once

    American Contract Systems is recalling angiography and coronary convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C ANGIO CUSTOM RCH UDCO10F CVL CORONARY PACK 219224
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0170-2026·2025-10-22

    Basic biopsy trays recalled after entire lot was sterilized more than once

    American Contract Systems is recalling a Basic Biopsy Tray lot that was re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Basic Biopsy Tray, Item Number NMBP44L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0156-2026·2025-10-22

    LOGIQ P10 HD systems recalled over inaccurate liver steatosis measurement values

    GE is recalling 31 LOGIQ P10 R4.5 HD ultrasound systems running software R4.5.7 because the Ultrasound-Guided Attenuation Parameter measurement may display inaccurate liver steatosis values.

    Product
    LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0150-2026·2025-10-22

    Bipolar femoral heads recalled over packaging that may compromise sterility

    BioPro is recalling 147 bipolar heads over a potential packaging issue that could compromise the sterile barrier and risk infection if implanted.

    Product
    BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR HEAD 41MM 18134 BIPOLAR HEAD 42MM 18135 BIPOLAR HEAD 43MM 18136 BIPOLAR HEAD 44MM 18137 BIPOLAR HEAD 45MM 18138 BIPOLAR HEAD 46MM 18139 BI
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0152-2026·2025-10-22

    Ceramic endo modular heads recalled over sterile barrier packaging defect

    BioPro is recalling 147 ceramic Endo Modular Heads over a potential packaging issue that could compromise the sterile barrier and risk infection if implanted.

    Product
    BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO MODULAR CERAMIC MD 51 13007 ENDO MODULAR CERAMIC SH 41 13008 ENDO MODULAR CERAMIC SH 43 13009 ENDO MODULAR CER
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0203-2026·2025-10-22

    Paclitaxel infusion sets recalled from one lot because IV sets may leak

    Baxter is recalling 27,072 CLEARLINK System Paclitaxel Sets from one lot because the IV sets may leak.

    Product
    CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-inch (2.7 meters), Product Code 2R8858
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0198-2026·2025-10-22

    Fourteen inch extension sets recalled from one lot because sets may leak

    Baxter is recalling 2,304 CLEARLINK System straight-type extension sets with a retractable collar from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimeters), Product Code 2C8632
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0193-2026·2025-10-22

    Retractable collar solution sets recalled across many lots because sets may leak

    Baxter is recalling 958,351 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a retractable collar because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8537
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0174-2026·2025-10-22

    Cystoscopy procedure packs recalled after being sterilized more than once

    American Contract Systems is recalling cysto convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO PACK- 212487 PLBY52E CYSTO PACK UDCY31Z CYSTO PACK - 206047 UICY28L MOR CYSTO PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0134-2026·2025-10-22

    Cyclodialysis surgical instruments recalled over compromised sterile packaging integrity

    Iantrek is recalling 1,262 CycloPen Microinterventional Cyclodialysis Systems over the potential for compromised integrity of the sterile packaging.

    Product
    Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis device is a manual surgical instrument used for the ab-interno construction or modification of a cyclodialysis, followed by delivery of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0138-2026·2025-10-22

    TENACIO pumps with InhibiZone recalled over inflation and deflation issues

    Boston Scientific is recalling 59 TENACIO Pump with InhibiZone units, UPN 72404429, because of the potential for inflation or deflation performance issues or difficulties.

    Product
    TENACIO Pump with InhibiZone; UPN: 72404429;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0179-2026·2025-10-22

    Gynecology procedure packs recalled after being sterilized more than once

    American Contract Systems is recalling gynecology, laparoscopy and hysteroscopy convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY16AE ASC HYSTEROSCOPY PACK (PS 020634)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0183-2026·2025-10-22

    Spine and laminectomy packs recalled after being sterilized more than once

    American Contract Systems is recalling spine, laminectomy and neuro angio convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCNA47B NEURO ANGIO 0246971 SFLM54AB LAMINECTOMY PACK - 219659 UDLM94AA LAMINECTOMY PACK - 206064 UILM77AU LAMINECTOMY (PS 039500) UINR44P NEURO IR PERIPHERAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0184-2026·2025-10-22

    Orthopedic procedure packs recalled after being sterilized more than once

    American Contract Systems is recalling shoulder, hip and extremity convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M SHOULDER ARTHROSCOPY GRTS90G TOTAL SHPULDER PACK HGHI26G HIP PINNING PACK HJTO25C TOTAL HIP ACCESSORY PACK HNEX60L EXTREMITY PACK IAHD53C HAND PACK IAS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0195-2026·2025-10-22

    Filtered solution sets recalled from one lot because IV sets may leak

    Baxter is recalling 106,176 CLEARLINK System Continu-Flo solution sets with a 0.2 micron filter from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8571
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0202-2026·2025-10-22

    Three valve solution sets recalled from one lot because sets may leak

    Baxter is recalling 12,720 CLEARLINK System Continu-Flo solution sets with three luer activated valves from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2026·2025-10-22

    Extension IV sets recalled from one lot because the sets may leak

    Baxter is recalling 16,416 CLEARLINK System straight-type extension sets from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0044-2026·2025-10-22

    Strawberry milk pints recalled over potential foreign object contamination

    Wawa Beverage Company is recalling 30 units of Wawa Strawberry Lowfat Milk in 16 oz bottles for potential foreign object contamination.

    Product
    Wawa Strawberry Milk, Lowfat Milk, 16 oz (Pint), Plastic bottle, Stored refrigerated, UPC: 00726191015134
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0181-2026·2025-10-22

    Caesarean section packs recalled after being sterilized more than once

    American Contract Systems is recalling C-section convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0194-2026·2025-10-22

    Three valve retractable collar sets recalled across many lots for leak potential

    Baxter is recalling 1,167,120 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a retractable collar because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8541
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0186-2026·2025-10-22

    PICC and gastrostomy tube packs recalled after being sterilized more than once

    American Contract Systems is recalling PICC G-Tube convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits UDPG88W PICC G-TUBE PACK-230209
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0178-2026·2025-10-22

    Head and neck procedure packs recalled after being sterilized more than once

    American Contract Systems is recalling ENT and head and neck convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0144-2026·2025-10-22

    LGX preconnect pumps recalled over inflation and deflation performance issues

    Boston Scientific is recalling 490 LGX Preconnect devices with TENACIO Pump and InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) 72404456 (15CM IP IZ), (7) 72404457 (18CM IP IZ), (8) 72404458 (21CM IP IZ);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0058-2026·2025-10-22

    Aluminium cookware sets recalled for containing elevated levels of lead

    Goyal Group is recalling 293 sets of Silver Horse aluminium milk pans and mathar kadai cookware because they contain elevated levels of lead.

    Product
    1. SILVER HORSE - PURE ALUMINIUM MADE IN INDIA - ALUMINIUM MILK PAN 4 inches 2. SILVER HORSE - ALUMINIUM MATHAR KADAI - 26 inches
    Category
    Consumer Product
    Distribution
    13 states
  • HighFDA (Food)·H-0043-2026·2025-10-22

    Whole milk pints recalled over potential foreign object contamination

    Wawa Beverage Company is recalling 154 units of Wawa whole milk in 16 oz bottles for potential foreign object contamination.

    Product
    Wawa HVD (Whole) Milk , 16 oz (Pint), Plastic bottle, Stored refrigerated, UPC: 00726191014403
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·H-0040-2026·2025-10-22

    Canned sliced pears recalled over potential lead contamination in one lot

    Pacific Coast Producers is recalling 203 cases of sliced pears in organic pear juice, distributed by Wegmans, for potential contamination with lead.

    Product
    Pears SLICED in Organic Pear Juice from Concentrate; NET WT 15 OZ (425 g); Ingredients: Organic Pears, Water, Organic Pear Juice Concentrate; Distributed By: Wegmans Food Markets, Inc. Rochester, NY 14603
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0140-2026·2025-10-22

    CX preconnect pumps without InhibiZone recalled over inflation deflation issues

    Boston Scientific is recalling CX Preconnect with TENACIO Pump without InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0029-2026·2025-10-22

    Parkinson's tablets recalled after bottles contained a higher strength tablet

    Rising Pharma is recalling 2,064 bottles of Carbidopa, Levodopa and Entacapone Tablets 25/100/200 mg after a sealed bottle was found to contain the 37.5/150/200 mg strength instead.

    Product
    CARBIDOPA, LEVODOPA AND ENTACAPONE — CARBIDOPA, LEVODOPA AND ENTACAPONE (CARBIDOPA, LEVODOPA AND ENTACAPONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2026·2025-10-22

    LOGIQ P9 ultrasound systems recalled over inaccurate liver steatosis measurements

    GE is recalling 37 LOGIQ P9 R4.5 ultrasound systems running software R4.5.7 because the Ultrasound-Guided Attenuation Parameter measurement may display inaccurate liver steatosis values.

    Product
    LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0034-2026·2025-10-22

    Raw cashew pouches recalled because the product contains undeclared pine nut

    Now Foods is recalling 1,689 pouches of NOW Real Food Organic Unsalted Whole Raw Cashews because the product contains undeclared pine nut.

    Product
    NOW Real Food Organic Unsalted Whole Raw Cashews, 10 oz. pouch, UPC 7 33739 07066 1 Product Code 7066
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0176-2026·2025-10-22

    Cardiovascular procedure packs recalled after being sterilized more than once

    American Contract Systems is recalling cardiovascular convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACEMAKER PACK- 206010 UDBH37AW BASIC HEART PACK - 206044 UHPP82AH PERIPHERAL PACK - 209533 UICD62AN CARDIOVASCUALR SUPPLY (PS 907285) UICT16F CARDIO THORACIC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0196-2026·2025-10-22

    Three valve filtered solution sets recalled because IV sets may leak

    Baxter is recalling 8,368 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a 0.2 micron filter from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2C8593
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0191-2026·2025-10-22

    Non-vented IV solution sets recalled from one lot because sets may leak

    Baxter is recalling 1,440 CLEARLINK System non-vented solution sets from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0153-2026·2025-10-22

    Femoral head implants recalled over packaging that may compromise sterile barrier

    BioPro is recalling 147 femoral head implants over a potential packaging issue that could compromise the sterile barrier and present a risk of infection if implanted.

    Product
    BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT 14095 HEAD FEMORAL 32 MD LT 14096 HEAD FEMORAL 32 LG LT
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0022-2026·2025-10-22

    Sunscreen lotion recalled after failing total aerobic microbial count testing

    SV Labs Prescott is recalling 11,386 tubes of Aloe Up Sport Performance Sunscreen Lotion SPF 30 after the firm released and distributed product that failed total aerobic microbial count testing.

    Product
    Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 112, Eden Prairie, Minnesota 55344
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0131-2026·2025-10-22

    Carotid stent systems recalled because integrated filter may not fully open

    Contego Medical is recalling 568 Neuroguard IEP carotid stent systems because the integrated filter may not open, or may not fully open, during sheath retraction and filter knob operation.

    Product
    Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0740-140-2, NG-NV-7-40, NG-0640-140-2, NG-NV-6-40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0197-2026·2025-10-22

    Forty four inch extension sets recalled because the IV sets may leak

    Baxter is recalling 15,552 CLEARLINK System 44-inch straight-type extension sets from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0169-2026·2025-10-22

    Monitor display cables recalled over inadequate shielding and electromagnetic interference

    Spacelabs Healthcare is recalling 16,898 DVI display cables because inadequate shielding may allow electromagnetic interference with other electronically sensitive medical devices in use.

    Product
    Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Product Description: 16 inch DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0172-2026·2025-10-22

    General and laparotomy packs recalled after being sterilized more than once

    American Contract Systems is recalling general, chest, laparotomy and interventional radiology convenience packs that were re-gassed after a sterilization nonconformance.

    Product
    Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK - 205939 ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953 CFLA39G LAPAROTOMY PACK CIBL33I BASIC LAP PACK EVMN24E MINOR ESC EVST48E STARTER FDTA11AA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0168-2026·2025-10-22

    Twelve foot display cables recalled over inadequate shielding and interference

    Spacelabs Healthcare is recalling 820 twelve-foot DVI display cables because inadequate shielding may allow electromagnetic interference with other electronically sensitive medical devices in use.

    Product
    Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0147-2026·2025-10-22

    Linear cutter reloads recalled after devices were shipped unsterilized

    Ethicon Endo-Surgery is recalling three ECHELON LINEAR Cutter Reload 80 mm Blue units because the devices were shipped unsterilized.

    Product
    ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0148-2026·2025-10-22

    Metal and ceramic femoral heads recalled over sterile barrier packaging defect

    BioPro is recalling 147 cobalt chromium and ceramic femoral heads over a potential packaging issue that could compromise the sterile barrier and risk infection if implanted.

    Product
    BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD FEMORAL 28MM-3 19005 HEAD FEMORAL 28MM+0 19006 HEAD FEMORAL 28MM+3 19007 HEAD
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0173-2026·2025-10-22

    Labor and delivery packs recalled after being sterilized more than once

    American Contract Systems is recalling labor, delivery and birthing room convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DELIVERY AKDV96B VAGINAL DELIVERY EVBH28D BIRTHING ROOM PACK UPVD01K VAGINAL DELIVERY PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0026-2026·2025-10-22

    Everolimus tablets recalled for out of specification impurity in one lot

    Endo USA is recalling 1,041 cartons of Everolimus tablets 5mg after the lot returned an out-of-specification result for impurity IP-C.

    Product
    Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0023-2026·2025-10-22

    Hydromorphone syringes recalled over incorrect or missing lot and expiry

    STAQ Pharma is recalling one lot of Hydromorphone HCL PF 10mg/50 mL injection syringes because of incorrect or missing lot and expiration date information on the label.

    Product
    Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0025-2026·2025-10-22

    Fentanyl citrate syringes recalled over incorrect or missing lot and expiry

    STAQ Pharma is recalling three lots of FentaNYL Citrate PF 500mcg/50 mL injection syringes because of incorrect or missing lot and expiration date information on the label.

    Product
    FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0102-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0027-2026·2025-10-22

    Sucralfate tablets recalled after bankruptcy left quality program unmonitored

    Amerisource Health Services is recalling 27,868 blister packs of Sucralfate Tablets USP 1 gram because, after a Chapter 11 filing, the firm cannot monitor its quality program.

    Product
    Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0024-2026·2025-10-22

    Ketamine syringes recalled over incorrect or missing lot and expiry

    STAQ Pharma is recalling one lot of Ketamine Hydrochloride 50mg/5 mL injection syringes because of incorrect or missing lot and expiration date information on the label.

    Product
    Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
    Category
    Drug
    Distribution
    Distributed nationwide

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