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

18551–18575 of 27647

HighFDA (Devices)·Z-0986-2018·2018-03-21
Alden Optical Recalls HP59 Sphere Daily Wear Soft Contact Lenses
Alden Optical is recalling HP59 Sphere Daily Wear Soft contact lenses because they lack sterility assurance. The recall affects units distributed in the US and Canada.
Product
Alden HP59 Sphere Daily Wear Soft contact; Catalog Number: AOHPS59 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia).…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0972-2018·2018-03-21
Medimop Recalls Vial2Bag DC Devices Due to IV Port Separation Risk
Medimop is recalling specific lots of Vial2Bag DC devices because the IV Port may separate from the body during use.
Product
Vial2BagDC, Product Number 6070112. The 20mm Vial2Bag DC device, is intended for use in healthcare facilities or in-home environment by the patient or care-giver to aid and support prescribed treatment and therapy. The device consists of the Vial2Bag piercing spike and…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0976-2018·2018-03-21
Deerfield IMRIS T2X Table Recall Due to Rotational Locking Defect
Deerfield Imaging is recalling 16 IMRIS T2X tables because the rotational locking mechanisms can disengage, potentially causing unintended table movement.
Product
IMRIS T2X Table, Part Number 109682-600
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0993-2018·2018-03-21
Zimmer Biomet Recalls Juggerknot 2.9mm Suture Anchors for Hip Arthroplasty
Zimmer Biomet is recalling 50 units of Juggerknot 2.9mm suture anchors used in hip arthroplasty. The recall is limited to the state of Texas.
Product
JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0938-2018·2018-03-21
Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems
Ion Beam Applications is recalling 37 Proteus 235 Proton Therapy Systems due to a risk of patient misalignment when using treatment plans with multiple isocenters.
Product
Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1065-2018·2018-03-21
Siemens ACUSON SC2000 Ultrasound System Recalled for EROA Underestimation
Siemens Medical Solutions is recalling 564 ACUSON SC2000 ultrasound systems because a specific application may underestimate the Effective Regurgitant Orifice Area (EROA) compared to other transducers.
Product
ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1028-2018·2018-03-21
Zimmer Biomet Recalls Hip Implants Due to Packaging Residue
Zimmer Biomet is recalling specific Versys hip prostheses because LDPE packaging may leave residue on the polished implant surface.
Product
VERSYS 7.5 INCH BEADED FC REV 13.5X190MM STRAIGHT Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0946-2018·2018-03-21
3M Recalls Ankle Braces Due to Missing Latex Warning Label
3M is recalling specific ACE and Futuro ankle braces because they contain natural latex rubber but lack the required caution statement.
Product
ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0942-2018·2018-03-21
Draeger Infinity Dual Hemo MCable Pod Recall for Liquid Ingress Risk
Draeger Medical Systems is recalling 2,760 Dual Hemo MCable Pods (Revisions 15 and 16) because they may allow liquid ingress, potentially causing incorrect invasive blood pressure readings.
Product
INFINITY DUAL HEMO MCable Pod
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1067-2018·2018-03-21
Diagnostica Stago Recalls Neoplastine Cl Plus Reagent Due to Homogeneity Defect
Diagnostica Stago is recalling Neoplastine Cl Plus reagent vials because a defect may cause inaccurate prothrombin time test results.
Product
Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT).
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1014-2018·2018-03-21
Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue
Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surfaces.
Product
BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0980-2018·2018-03-21
Zimmer Biomet Recalls Humeral Stems Due to Incorrect Lot Number Etching
Zimmer Biomet is recalling 12 Humeral Stems because two lots were commingled and etched with incorrect lot numbers, creating a risk of using the wrong implant size.
Product
Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0975-2018·2018-03-21
Deerfield Imaging Recalls IMRIS ORT100 Tables Due to Locking Mechanism Defect
Deerfield Imaging is recalling 15 IMRIS ORT100 tables because the rotational locking mechanisms can disengage, potentially causing unintended movement.
Product
IMRIS ORT100 Table, Part Number 110470-000
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1006-2018·2018-03-21
Brainlab ExacTrac Software Recall for Beam Authorization Misinterpretation Risk
Brainlab AG is recalling ExacTrac Patient Positioning System software versions 6.0 through 6.5 due to a risk of misinterpreting beam authorization when used with specific Varian accelerators.
Product
ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0988-2018·2018-03-21
Alden HP54 Toric Contact Lenses Recalled for Sterility Assurance Issues
Alden Optical is recalling HP54 Toric Daily Wear Soft contact lenses because they lack sterility assurance. Consumers should stop using the affected lenses.
Product
Alden HP54 Toric Daily Wear Soft contact; Catalog Number: AOHPT54 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1007-2018·2018-03-21
Medtronic Recalls Unsterilized Acute Dual Lumen Dialysis Catheters
Medtronic is voluntarily recalling one lot of MAHURKAR Elite Acute Dual Lumen Dialysis Catheters because they were distributed without being sterilized.
Product
MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0971-2018·2018-03-21
Baxter SIGMA Spectrum Infusion Pump Recall for Pumping Mechanism Wear
Baxter is recalling SIGMA Spectrum Infusion Pumps because excessive wear in the pumping mechanism may cause over- or under-infusion of fluids.
Product
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1017-2018·2018-03-21
Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue
Zimmer Biomet is recalling specific hip and knee implants because LDPE packaging may leave residue on the polished surfaces.
Product
CPT 12/14 COCR SIZE 1 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0987-2018·2018-03-21
Alden HP49 Toric Contact Lenses Recalled for Sterility Assurance Issues
Alden Optical is recalling 56 units of Alden HP49 Toric Daily Wear Soft contact lenses because they lack sterility assurance. The lenses were distributed in 25 US states and Canada.
Product
Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1074-2018·2018-03-21
Smiths Medical Recalls Misassembled Power PORT-A-CATH II Implantable Port Kits
Smiths Medical ASD Inc. is recalling 1,077 units of Power PORT-A-CATH II kits that may contain incorrect introducer sizes or locking collars.
Product
Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA); d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1025-2018·2018-03-21
Zimmer Biomet Recalls Hip Implants Due to Packaging Residue
Zimmer Biomet is recalling specific Versus hip prostheses because LDPE packaging may leave residue on the polished implant surface.
Product
VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1070-2018·2018-03-21
Stanbio Recalls RaPET RF Latex Reagent Due to False Positive Test Results
Stanbio Laboratory is recalling RaPET RF Latex Reagent because it causes all patient serum samples to yield weakly positive test results.
Product
RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1009-2018·2018-03-21
Zimmer Biomet Recalls Nondegradable Soft Tissue Fixation Fasteners
Zimmer Biomet is recalling 429 units of nondegradable soft tissue fixation fasteners because the implant shaft may shift and fall out during device opening.
Product
fastener, fixation, nondegradable, soft tissue
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0977-2018·2018-03-21
ZOLL Adult Defibrillator Electrodes Recall for Pediatric Energy Delivery Risk
ZOLL Medical is recalling specific adult defibrillator electrodes that may cause R Series devices to deliver pediatric energy levels instead of adult levels.
Product
OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 8900 0224 01 (single electrode, UDI: 00847946016272) Product Usage: Intended Use: Defibrillation, Cardioversion, Noninvasive Pacing, EGG…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1066-2018·2018-03-21
Diagnostica Stago Recalls Neoplastine Cl Plus Prothrombin Time Reagent Kits
Diagnostica Stago is recalling 1,636 Neoplastine Cl Plus kits due to a defect causing inaccurate prothrombin time test results.
Product
Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).
Category
Medical Device
Distribution
0 states

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18551–18575 of 27647