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

13701–13725 of 27471

HighFDA (Devices)·Z-2026-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled for Welded Tip Breakage Risk
K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during surgical procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90165, UDI # 10888857108783, Size 28x6mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2062-2020·2020-05-27
Innovasis Recalls Oryx Cervical Screw Caddies Due to Incorrect Labeling
Innovasis is recalling six Oryx Cervical Screw Caddies because the labels for fixed and variable rescue screws are swapped. This mislabeling could lead to improper screw installation.
Product
Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical Plate System is intended for use in anterior cervical fixation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2033-2020·2020-05-27
Advanced Bionics Recalls HiResolution Bionic Ear Systems Due to Fluid Ingress
Advanced Bionics is recalling HiResolution Bionic Ear Systems because body fluid can enter the device, causing hearing performance degradation.
Product
AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2028-2020·2020-05-27
K2M Recalls Aleutian Lordotic Spreader Due to Tip Breakage Risk
K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip can break off during spinal procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90169, UDI # 10888857108820, Size 28x10mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2063-2020·2020-05-27
Frames Direct Prescription Spectacle Lenses Recalled for Shatter Resistance Failure
Frames Direct is recalling 87 pairs of prescription spectacle lenses that failed shatter resistance safety specifications, posing a risk of cracked or broken lenses.
Product
Frames Direct Prescription Spectacle Lenses included in the frame brands
Category
Medical Device
Distribution
36 states
HighFDA (Devices)·Z-2090-2020·2020-05-27
Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect
Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within the inner packaging, resulting in coating debris.
Product
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile, Catalog # 504-02-60D-L, UDI (01)07613327012422(17)
Category
Medical Device
Distribution
30 states
HighFDA (Devices)·Z-2016-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled for Tip Breakage Risk
K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during surgical procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90127, UDI # 10888857108400, Size 24x10mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2036-2020·2020-05-27
Applied Medical Recalls Stealth Spring Clips for Insufficient Vessel Occlusion
Applied Medical Resources Corp is recalling 2,240 Stealth Spring Clips because they may fail to sufficiently occlude blood vessels during surgery.
Product
STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2071-2020·2020-05-27
Binding Site Optilite Clinical Chemistry Analyzer Recalled for Software Accuracy Issue
The Binding Site Group is recalling 36 Optilite Clinical Chemistry Analyzers due to a software issue that may affect result accuracy.
Product
The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1995-2020·2020-05-27
Medtronic Nexframe Stereotactic System Recalled for Lead Placement Inaccuracies
Medtronic is recalling the Nexframe Stereotactic System and specific software combinations due to potential inaccuracies in deep brain stimulation lead placement.
Product
Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2032-2020·2020-05-27
Advanced Bionics Recalls HiResolution Bionic Ear Systems Due to Fluid Entry
Advanced Bionics is recalling 8,159 HiResolution Bionic Ear Systems because body fluid may enter the device, causing hearing performance degradation.
Product
AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2020-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk
K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during surgical procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90149, UDI # 10888857108622, Size 28x4mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2019-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled for Tip Breakage Risk
K2M, Inc. is recalling Aleutian Lordotic Spreader systems because the welded tips may break off during spinal procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90139, UDI # 10888857108523, Size 24x8mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2070-2020·2020-05-27
Baylis Medical Recalls NRG RF Transseptal Kits Due to Packaging Defect
Baylis Medical is recalling NRG RF Transseptal Kits because sterile packaging may be compromised during shipping, posing a remote risk of infection.
Product
NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545S, NTK-710-8555S, NTK-711-8545S, NTK-711-8555S, NTK-710-8545N, NTK-711-8545N and NTK-711-8555N.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2095-2020·2020-05-27
Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect
Howmedica Osteonics is recalling Stryker Restoration Anatomic Shells because the device may detach from its post inside the packaging, resulting in loose coating debris.
Product
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 left, Sterile, Catalog # 504-02-66F-L, UDI (01)07613327012491(17)
Category
Medical Device
Distribution
30 states
HighFDA (Devices)·Z-2043-2020·2020-05-27
Medline Silicone Foley Catheter Recalled Due to Loose Silicone Particulate
Medline Industries is recalling specific lots of silicone Foley catheters because loose silicone particulate was found on the device shaft.
Product
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2084-2020·2020-05-27
Stryker Restoration Anatomic Shell Recalled for Packaging Defect
Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shells because the device may fall off its post within the inner packaging, resulting in loose components and coating debris.
Product
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17)
Category
Medical Device
Distribution
30 states
HighFDA (Devices)·Z-2061-2020·2020-05-27
Bovie Medical Recalls Renuvion J-Plasma Precise Handpieces Due to Fracture Risk
Bovie Medical Corporation is recalling Renuvion/J-Plasma Precise Handpieces because unexpected stress fractures may cause the shaft to fragment during clinical use.
Product
Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX- 330BPS, APYX-150B, APYX-270B, APYX-330B, APYX- 270BPP, and APYX-330BPS. Product Usage: for electrosurgical cutting, coagulation and ablation of soft tissue during open…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2065-2020·2020-05-27
BD Posiflush SF Saline Flush Syringe Recalled for Packaging Holes
Becton Dickinson is recalling BD Posiflush SF Saline Flush Syringes because holes in the packaging may compromise the sterile field.
Product
BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2083-2020·2020-05-27
NelDerm Hydrogel Dressing Recalled for Foreign Material in Packaging
Nelson Innovations is recalling NelDerm Hydrogel Dressings due to foreign material near the adhesive edge within the pouch packaging.
Product
NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2040-2020·2020-05-27
Medline Recalls Surgical Kits Due to Potential Loss of Sterility
Medline is recalling 92,902 custom surgical convenience kits because packaging seal voids may have caused a loss of sterility on the outside of the foil pouch.
Product
Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follows: Part Description Part Number ABDOMINAL HYSTERECTOMY DYNJ906478 ABDOMINAL HYSTERECTOMY DYNJ906478A ACCESSORY HIP PACK-LF DYNJ0781865M ARTHRO/SHOULDER…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2050-2020·2020-05-27
Cardinal Health Recalls Urine Drug Controls Due to Temperature Abuse
Cardinal Health is recalling Alere Professional Urine Drug Controls (Lot KN00146) because they were stored outside approved temperature ranges, which may result in patient misdiagnosis.
Product
Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2048-2020·2020-05-27
BD BBL Gram Stain Kit Recalled for Potential False-Positive Results
Becton Dickinson is recalling 1,469 BD BBL Gram Stain Kits because increased artifacts may be mistaken for bacteria, leading to false-positive results.
Product
BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Catalog Number: 212539 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2054-2020·2020-05-27
Skeletal Kinetics Recalls Cranio/Sculpt C Bone Void Filler Due to Sterilization Concerns
Skeletal Kinetics is recalling 125 units of Cranio/Sculpt C bone void filler because one unit may have been mispackaged and not sterilized.
Product
Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranial bone defects and craniotomy cuts with a surface area no larger…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2044-2020·2020-05-27
Medline Recalls Silicone Foley Catheters Due to Loose Particulate
Medline Industries is recalling specific lots of silicone Foley catheters because loose silicone particulate was found on the device shaft.
Product
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
Category
Medical Device
Distribution
Distributed nationwide

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13701–13725 of 27471