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

19701–19725 of 27647

SevereFDA (Devices)·Z-1822-2017·2017-04-26
Philips Allura Xper Systems Recalled for Chiller Leak Fire Risk
Philips is recalling specific Allura Xper systems equipped with Laird chillers because a leak in the cooling system could cause liquid to drip onto electrical components, potentially leading to fire.
Product
The following systems are only affected if a Laird chiller is installed (11NC: 98960021599): Allura Xper Releases 3 to 8.1: Allura Xper FD10 (C+F). 722003; Allura Xper FD10/10 722005; Allura Xper FD20 722006; Allura Xper FD20/10 and FD20/20 722008; Allura Xper FD10 722010…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1870-2017·2017-04-26
Cook Inc. Recalls Bush Ureteral Illuminating Catheter Sets Due to Overheating Risk
Cook Inc. is recalling Bush DL and SL Ureteral Illuminating Catheter Sets because the devices may overheat, melt, and burn patients.
Product
Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1848-2017·2017-04-26
Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recall for Blade Detachment Risk
Smith & Nephew is recalling ACUFEX TRUNAV Retrograde Drills because the cutting blade may detach or the drill head may fracture during use.
Product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10.5MM Product Number: 72204047 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1850-2017·2017-04-26
Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recall for Blade Detachment
Smith & Nephew is recalling ACUFEX TRUNAV Retrograde Drills because the cutting blade may detach or the drill head may fracture during use.
Product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11.5MM Product Number: 72204049 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1864-2017·2017-04-26
BD MAX System Software Version 4.44A Recalled for Potential Incorrect Results
BD Life Sciences is recalling BD MAX System software version 4.44A due to a defect that may cause incorrect result reporting for specific user-defined protocol assays.
Product
Software version 4.44A utilized on the BD MAX System
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-1825-2017·2017-04-26
Cincinnati Sub-Zero Recalls Hemotherm CE Heater-Cooling Devices Due to Fuse Defect
Cincinnati Sub-Zero is recalling 390 Hemotherm CE model 400CE heater-cooling devices because improperly rated fuses were used in their manufacture.
Product
Hemotherm CE, model 400CE, Heater-Cooling Device
Category
Medical Device
Distribution
25 states
HighFDA (Devices)·Z-1869-2017·2017-04-26
Elcam Minimal Residual Volume Stopcock Recalled for Punctures
Elcam Medical, Inc. is recalling 810 units of Minimal Residual Volume Luer-activated Swabable-stockcock devices found to have punctures.
Product
Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls Product Usage: indicated for fluid flow directional control and for providing access ports for administration of intravenous solutions. Typical uses include pressure monitoring…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1873-2017·2017-04-26
Laerdal Compact Suction Unit 4 Recalled for Electronic Component Damage
Laerdal Medical Corporation is recalling 4,377 Compact Suction Unit 4 devices because an electronic component may be damaged, potentially affecting the On/Off functionality.
Product
Laerdal Compact Suction Unit ¿ 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ml Complete unit (US), 88006103 - LCSU 4, 300 ml Complete unit (UK), 88006140 - LCSU 4, 300 ml Complete unit (EUR), 881151 - Replacement unit…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1861-2017·2017-04-26
Zimmer Biomet Recalls Polyethylene Knee Implants Due to Endotoxin Levels
Zimmer Biomet is recalling 28,253 polyethylene knee implants because endotoxin levels exceeded process maximum limits. The affected products were distributed worldwide.
Product
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1847-2017·2017-04-26
Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recalled for Blade Detachment Risk
Smith & Nephew is recalling ACUFEX TRUNAV Retrograde Drills because the cutting blade may detach or the drill head may fracture during use.
Product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10MM Product Number: 72204046 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1845-2017·2017-04-26
Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recall for Blade Detachment Risk
Smith & Nephew is recalling ACUFEX TRUNAV Retrograde Drills because the cutting blade may detach or the drill head may fracture during use.
Product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9MM Product Number: 72204044 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1858-2017·2017-04-26
Zimmer Biomet Recalls Polyethylene Implants Due to High Endotoxin Levels
Zimmer Biomet is recalling BIO PLUG 10MM polyethylene implants because endotoxin levels exceeded process maximum limits.
Product
various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable, implantable devices designed to be inserted into the medullary canal of a bone during orhtopedic surgery to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1834-2017·2017-04-26
Signal Medical Soft Face Mallet Recalled for Tip Detachment Risk
Signal Medical Corporation is recalling 1,640 Soft Face "No Bounce" Mallets because the poly tip may detach during use, posing a risk of foreign material in the surgical field.
Product
Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1868-2017·2017-04-26
FDA Recalls 84 Zimmer CAS SmartTools Knee System Instruments
Orthosoft, Inc. dba Zimmer CAS is recalling 84 SmartTools Knee System Orthopedic Stereotaxic Instruments due to complaints of bent or broken Drive Pins.
Product
SmartTools Knee System Orthopedic Stereotaxic Instrument
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1859-2017·2017-04-26
Zimmer Biomet Recalls Polyethylene Implants Due to High Endotoxin Levels
Zimmer Biomet is recalling 28,253 polyethylene implants for shoulder and elbow replacements because endotoxin levels exceeded process maximum limits.
Product
various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System Product Usage: Shoulder Replacement Elbow Replacement
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1860-2017·2017-04-26
Zimmer Biomet Recalls Polyethylene Hip Implants Due to Endotoxin Levels
Zimmer Biomet is recalling 28,253 polyethylene hip implant components worldwide because endotoxin levels exceeded process maximum limits.
Product
various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option Head E1 RingLoc Bi-Polar Freedom Constrained Liner +5mm Hi-Wall ArcomXL All Poly Rimloc E1 10 Degree Liner RingLoc +3mm Hi-Wall…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1867-2017·2017-04-26
Mizuho Wilson Frame Pads Recalled for Potential Pressure Injury Risk
Mizuho OSI is recalling 216 Wilson Frame Pads due to a design deficiency that may allow patients to contact the frame's carbon fiber structure, potentially causing pressure injuries.
Product
216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1862-2017·2017-04-26
Zimmer Biomet Recalls Polyethylene Implants Due to High Endotoxin Levels
Zimmer Biomet is recalling 28,253 custom polyethylene implants because endotoxin levels exceeded process maximum limits. The affected parts were distributed worldwide.
Product
various polyethylene implants Custom parts Product Usage: Custom
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1826-2017·2017-04-26
Cordis S.M.A.R.T. Flex Vascular Stent System Recalled for Deployment Difficulty
Cordis Corporation is recalling 2,700 units of the S.M.A.R.T. Flex Vascular Stent System due to deployment difficulty. The recall affects foreign markets only.
Product
Cordis S.M.A.R.T. Flex Vascular Stent System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1836-2017·2017-04-26
Valleylab Laparoscopic Handset Recalled for Activation Button Failure
COVIDIEN MEDTRONIC is recalling Valleylab Laparoscopic Handsets because customer reports indicate the device may continue operating after the activation button is released.
Product
Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk; Material # E2750NSB Product Usage: For use in 5mm cannulas or larger cannulas with 5mm adapters during laparoscopic and thorascopic procedures. For use with a minimum peak voltage of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1871-2017·2017-04-26
C.R. Bard Recalls SURESTEP Drainage Bags Due to Latex Mislabeling
C.R. Bard is recalling 5,030 SURESTEP Drainage Bags because they are labeled as latex-free but may contain natural rubber latex.
Product
SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.
Category
Medical Device
Distribution
24 states
HighFDA (Devices)·Z-1853-2017·2017-04-26
NAMIC Fluid Delivery Set Recalled for Potential Non-Sterility
Angiodynamics Inc. is recalling NAMIC Fluid Delivery Sets because they may not be sterile due to packaging errors.
Product
NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1863-2017·2017-04-26
Zimmer Biomet Recalls Polyethylene Implants Due to High Endotoxin Levels
Zimmer Biomet is recalling Repicci II Tibial Components for partial knee replacement because endotoxin levels exceeded process maximum limits.
Product
various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1830-2017·2017-04-26
Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems
Ion Beam Applications is recalling two Proteus 235 Proton Therapy Systems because users may restart aborted irradiations without selecting correct data.
Product
Proteus 235, Proton Therapy System
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1872-2017·2017-04-26
CP Medical Recalls PGCL Absorbable Sutures Due to Tensile Strength Failure
CP Medical Inc is recalling PGCL absorbable sutures because they failed to meet USP tensile strength requirements over their shelf life.
Product
PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493
Category
Medical Device
Distribution
22 states

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19701–19725 of 27647