DrugJan 17, 2024
Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box recall — FDA D-0220-2024
Defective Container: powder may leak out of the pouch
Class IFDA: CompletedInvaGen Pharmaceuticals, Inc.
Latest records
Latest recalls — page 461
The newest recall records with useful source details are listed here.
Medical DeviceJan 10, 2024
Philips Respironics Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B recall — FDA Z-0638-2024
The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is…
Class IIFDA: OngoingPhilips Respironics, Inc.
Medical DeviceJan 10, 2024
Randox Laboratories SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro recall — FDA Z-0624-2024
A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL.
Class IIIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceJan 10, 2024
Merit Medical Systems Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY recall — FDA Z-0629-2024
The sterility of microcatheter and infusion system devices cannot be guaranteed.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceJan 10, 2024
Zimmer Biomet Spine Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with recall — FDA Z-0639-2024
Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of…
Class IIFDA: OngoingZimmer Biomet Spine Inc.
Medical DeviceJan 10, 2024
Busse Hospital Disposables Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE recall — FDA Z-0592-2024
Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance…
Class IFDA: OngoingBusse Hospital Disposables, Inc.
Medical DeviceJan 10, 2024
Abiomed Impella Connect, software portal for online device management that allows clinicians recall — FDA Z-0636-2024
The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; AIC alarm…
Class IIFDA: OngoingAbiomed, Inc.
Medical DeviceJan 10, 2024
Busse Hospital Disposables Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE recall — FDA Z-0593-2024
Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance…
Class IFDA: OngoingBusse Hospital Disposables, Inc.
Medical DeviceJan 10, 2024
Beaver Visitec International Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part recall — FDA Z-0632-2024
One lot of Conventional Crescent Knife 2.5mm, 55 degrees bevel-up contains a bevel down blade.
Class IIFDA: OngoingBeaver Visitec International, Inc.
Medical DeviceJan 10, 2024
Natus Medical External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only recall — FDA Z-0634-2024
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
Class IIFDA: OngoingNatus Medical Inc.
Medical DeviceJan 10, 2024
Keystone Industries KeySplint Hard Clear - Indicated for the fabrication of orthodontic and recall — FDA Z-0630-2024
Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint…
Class IIFDA: OngoingKeystone Industries
Medical DeviceJan 10, 2024
Natus Medical EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only recall — FDA Z-0635-2024
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
Class IIFDA: OngoingNatus Medical Inc.
Medical DeviceJan 10, 2024
Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A recall — FDA Z-0628-2024
The sterility of microcatheter and infusion system devices cannot be guaranteed.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceJan 10, 2024
Busse Hospital Disposables Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / recall — FDA Z-0594-2024
Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance…
Class IFDA: OngoingBusse Hospital Disposables, Inc.
Medical DeviceJan 10, 2024
Beaver Visitec International Xstar Kojo Safety Slit Knife, 2.5mm 45 Bevel Up, Part Number recall — FDA Z-0633-2024
One lot of Part Number 373025, Xstar Kojo Safety Slit Knife 2.5mm 45 bevel up, incorrectly contains a bevel down blade instead of a bevel up blade.
Class IIFDA: OngoingBeaver Visitec International, Inc.
Medical DeviceJan 10, 2024
Insulet Omnipod 5 App recall — FDA Z-0591-2024
The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user…
Class IFDA: OngoingInsulet Corporation
Medical DeviceJan 10, 2024
Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B recall — FDA Z-0627-2024
The sterility of microcatheter and infusion system devices cannot be guaranteed.
Class IIFDA: OngoingMerit Medical Systems, Inc.
FoodJan 10, 2024
Foremost Foods International Pamana Premium Bangus Belly recall — FDA F-0693-2024
Potential C. botulinum growth and toxin formation. Frozen bangus (milkfish) in reduced oxygen packaging does not contain instructions to keep frozen and instructions for proper thawing…
Class IIFDA: TerminatedForemost Foods International, Inc.
FoodJan 10, 2024
Foremost Foods International Pamana Premium Marinated Baby Bangus recall — FDA F-0691-2024
Potential C. botulinum growth and toxin formation. Frozen bangus (milkfish) in reduced oxygen packaging does not contain instructions to keep frozen and instructions for proper thawing…
Class IIFDA: TerminatedForemost Foods International, Inc.
FoodJan 10, 2024
Foremost Foods International Pamana Premium Marinated Bangus recall — FDA F-0692-2024
Potential C. botulinum growth and toxin formation. Frozen bangus (milkfish) in reduced oxygen packaging does not contain instructions to keep frozen and instructions for proper thawing…
Class IIFDA: TerminatedForemost Foods International, Inc.
FoodJan 10, 2024
BioMylz Pvt Spring Valley Biotin & Collagen Liquid, Natural Berry Flavor recall — FDA F-0664-2024
Potential mold contamination
Class IIFDA: TerminatedBioMylz Pvt. Ltd.
FoodJan 10, 2024
Carolina CoPacking Scratch PASTA Co MARINARA SAUCE NET WT recall — FDA F-0688-2024
During a contract inspection by the North Carolina Department of Agriculture, NCDA, informed the firm that the labeling does not list the common name of "milk".
Class IIFDA: OngoingCarolina CoPacking, LLC
FoodJan 10, 2024
Samsung Bean Sprout Sung Soy Bean Sprouts, 1lb packages, in plastic packages, 20 recall — FDA F-0690-2024
The firm initiated a recall of SoyBean Sprouts because product tested positive for Listeria monocytogenes.
Class IFDA: TerminatedSamsung Bean Sprout
VehicleJan 10, 2024
XC40 electrical system software recall — NHTSA campaign 24V010000
Volvo Car USA, LLC (Volvo Car) is recalling certain 2024 XC40 vehicles. A diagnostic error in the Central Electronic Module (CEM) software may cause the left rear turn signal indicator to…
electrical system softwareVolvo Car USA, LLC
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Recent recall archives
Browse recent months with enough recall history for useful comparison.
September 2026364 records · 4 categoriesAugust 2026302 records · 4 categoriesJuly 2026370 records · 4 categoriesJune 2026376 records · 4 categoriesMay 2026340 records · 4 categoriesApril 2026415 records · 4 categoriesMarch 2026190 records · 4 categoriesFebruary 2026331 records · 4 categoriesJanuary 2026212 records · 4 categoriesDecember 2025389 records · 4 categoriesNovember 2025326 records · 4 categoriesOctober 2025455 records · 4 categories