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 the agency’s own highest classification or reported deaths or serious injuries, 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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

24826–24850 of 40233

ModerateFDA (Devices)·Z-0757-2018·2018-03-07
Steris Recalls Vis-U-All High Temperature Sterilization Pouches Due to Ink Migration
Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Product
Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0706-2018·2018-03-07
Siemens Medical Solutions Recalls Artis Q and Q.Zen Systems
Siemens Medical Solutions is recalling Artis Q and Q.Zen systems due to a potential for liquid entry.
Product
Artis Q and Q.Zen, Model Numbers:10848280, 10848281, 10848282, 10848353 & 10848355
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0790-2018·2018-03-07
Avid Medical Recalls GYN Laparoscopy Kits With Foreign Material
Avid Medical is recalling 160 GYN laparoscopy kits because they may contain needles with loose polypropylene foreign material.
Product
AVID TruCustom GYN LAPAROSCOPY convenience kits, Item Code: LGHM013-06 and LGHM013-07
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-0826-2018·2018-03-07
Tosoh Bioscience Recalls ST AIA-PACK Progesterone III Assay Kits
Tosoh Bioscience is recalling ST AIA-PACK Progesterone III Assay kits because cross-reactivity with DHEA-S supplements can cause falsely elevated test results.
Product
ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
Category
Medical Device
Distribution
39 states
ModerateFDA (Devices)·Z-0806-2018·2018-03-07
Baxter Recalls Mislabeled 5 mL Oral Dispensers Due to Packaging Errors
Baxter Healthcare is recalling 2,800 units of 5 mL oral dispensers because the individual pouches are mislabeled with the wrong product code and volume.
Product
Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-0818-2018·2018-03-07
Zimmer Biomet Recalls Ziptight Ankle Fixation Devices Due to Missing Tip Protectors
Zimmer Biomet is recalling 885 Ziptight Ankle Syndesmosis Fixation Devices because they were packaged without tip protectors.
Product
Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.
Category
Medical Device
Distribution
29 states
ModerateFDA (Devices)·Z-0772-2018·2018-03-07
Steris V-PRO 60 Sterilizer Software Recall to Prevent Expired Sterilant Use
Steris Corporation is recalling 406 V-PRO 60 Low Temperature Sterilization Systems to update software that prevents the use of expired sterilant.
Product
V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)
Category
Medical Device
Distribution
45 states
ModerateFDA (Devices)·Z-0789-2018·2018-03-07
Avid Medical Recalls TruCustom Kits with Foreign Material in Needles
Avid Medical is recalling TruCustom GENERAL PACK kits because some contain needles with loose polypropylene foreign material above release specifications.
Product
AVID TruCustom GENERAL PACK convenience kits, Item Code: LGHM041-06 and LGHM041-08
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-0718-2018·2018-03-07
Keystone Dental Recalls Max Implant System Bone Taps Due to Mislabeling
Keystone Dental Inc. is recalling 72 units of the Max Implant System Bone Tap because an 8mm diameter tap was incorrectly marked and labeled as 7mm.
Product
Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and overdentures in patients with partial or full edentulism of the upper or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0725-2018·2018-03-07
Terumo Destination Guiding Sheath Recalled for Specification Deviation
Terumo Medical Corporation is recalling 33 units of Destination Guiding Sheath catheter introducers because the tucking depth feature is marginally outside the upper specification.
Product
Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0704-2018·2018-03-07
Philips ProGrade R1 Digital X-Ray Detector Recall for Image Transfer Failures
Philips is recalling 157 ProGrade R1 digital x-ray detectors because weak WiFi connections can cause image transfer failures, requiring patients to be re-exposed to radiation.
Product
digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a part of a radiographic system, the Philips ProGrade is intended to acquire, process, store, display, and export digital radiographic images. The Philips ProGrade is suitable for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0833-2018·2018-03-07
DePuy Orthopaedics Recalls DELTA XTEND Reverse Shoulder System Implants
DePuy Orthopaedics is recalling 23,053 DELTA XTEND Reverse Shoulder System implants because the epiphysis may not assemble to the stem, potentially causing surgical delays.
Product
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0709-2018·2018-03-07
Siemens Medical Solutions Recalls Wireless Foot Switches for X-Ray Systems
Siemens Medical Solutions is recalling wireless foot switches for Artis Q and Q.zen fluoroscopic systems because they may fail to release radiation due to external impacts.
Product
Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
Category
Medical Device
Distribution
52 states
ModerateFDA (Devices)·Z-0834-2018·2018-03-07
DePuy Orthopaedics Recalls DELTA XTEND Reverse Shoulder System Implants
DePuy Orthopaedics is recalling DELTA XTEND Reverse Shoulder System implants because the epiphysis may not assemble to the stem, potentially causing surgical delays.
Product
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0780-2018·2018-03-07
Avid Medical Recalls TruCustom DAVINCI PACK Convenience Kits
Avid Medical is recalling 50 TruCustom DAVINCI PACK convenience kits because they may contain needles with loose polypropylene foreign material.
Product
AVID TruCustom DAVINCI PACK convenience kits, Item Code: ADVU037-09
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-0808-2018·2018-03-07
Siemens Syngo.via Software Recall for Diagnostic Inconsistencies
Siemens Medical Solutions is recalling 30 Syngo.via systems with software version VB20A to resolve bugs and inconsistent diagnoses.
Product
Syngo.via systems with SW VB20A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0720-2018·2018-03-07
Siemens Recalls ADVIA Centaur T3 Kits Due to Barcode Scanning Issue
Siemens is recalling ADVIA Centaur T3 kits because a barcode scanning issue on the ADVIA Centaur XPT system may affect specific lots.
Product
ADVIA Centaur¿ T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. Measurements of triiodothyronine are used in the diagnosis and…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0784-2018·2018-03-07
Avid Medical Recalls Heart Cath Tray Kits Due to Foreign Material
Avid Medical is recalling 354 TruCustom Heart Cath Tray kits because they may contain loose polypropylene foreign material in the included needles.
Product
AVID TruCustom HEART CATH TRAY convenience kits, Item Code: LAKC022-06
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-0787-2018·2018-03-07
Avid Medical Recalls TruCustom Electro Physiology Kits Due to Foreign Material
Avid Medical is recalling 15 TruCustom Electro Physiology PK convenience kits because they may contain loose polypropylene foreign material in the needles.
Product
AVID TruCustom ELECTRO PHYSIOLOGY PK convenience kits, Item Code: LGHM033-04
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-0778-2018·2018-03-07
Alcon 25+ TOTALPLUS Vitrectomy Pak Recalled for Incorrect Probe Inclusion
Alcon is voluntarily recalling 300 units of the 25+ TOTALPLUS Vitrectomy Pak because a 23GA probe may be included instead of the required 25GA probe.
Product
Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0761-2018·2018-03-07
Steris Recalls Vis-U-All High Temperature Sterilization Pouches Due to Ink Migration
Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Product
Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0712-2018·2018-03-07
Atrium Medical Recalls ProLite Mesh Due to Incorrect Configuration Packaging
Atrium Medical is recalling 60 units of ProLite Mesh because the wrong mesh configuration was packaged in the pouch. The affected lots were distributed only to Spain.
Product
ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0827-2018·2018-03-07
Siemens BC Thrombin Reagent Kit Recall for Unexpected Prolonged Results
Siemens Healthcare Diagnostics is recalling specific lots of BC Thrombin Reagent Kits because they may produce unexpectedly prolonged Thrombin Time results for normal samples.
Product
BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time Product Usage: For in vitro diagnostic use. Reagent for the quantitative…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0745-2018·2018-03-07
Steris Recalls Vis-U-All High Temperature Tubing Due to Ink Migration
Steris Corporation is recalling Vis-U-All High Temperature Tubing because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Product
Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0705-2018·2018-03-07
Teleflex Recalls Rusch Greenlite MAC 1 Tracheal Intubation Devices
Teleflex Medical is recalling Rusch Greenlite MAC 1 devices because some pouches may contain the incorrect product size, specifically MAC 2 instead of MAC 1.
Product
Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.
Category
Medical Device
Distribution
0 states

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