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

36951–36975 of 40449

SevereFDA (Devices)·Z-0427-2014·2013-12-18
Cutera truSculpt Infrared System Recalled for Thermal Burn Risk
Cutera is recalling 451 truSculpt infrared systems because the device caused partial thickness thermal burns to the skin in two patients.
Product
Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0458-2014·2013-12-18
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Recalled
Ethicon is recalling Stratafix Symmetric PDS Plus Knotless Tissue Control Devices due to reported tab failures and fascial dehiscences in lower abdominal incisions.
Product
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0477-2014·2013-12-18
Zimmer Trabecular Metal Total Ankle Tibial Base Component Recall
Zimmer, Inc. is recalling specific sizes of the Trabecular Metal Total Ankle Tibial Base Component due to potential elevated levels of manufacturing residue.
Product
Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0456-2014·2013-12-18
IBA COMPASS Software Recall for Erroneous Dose Statistics
IBA Dosimetry GmbH is recalling COMPASS SW Version 3.0 due to a software defect that causes erroneous dose statistics and DVHs.
Product
iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0470-2014·2013-12-18
Beckman Coulter Recalls LH 750 Hematology Analyzers Due to Optical Degradation
Beckman Coulter is recalling LH 750 Hematology Analyzers because optical degradation may delay reporting results for specific blood cell counts.
Product
Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usage: The Coulter LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter¿ LH 750…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0476-2014·2013-12-18
Zimmer Total Ankle Components Recalled for Manufacturing Residue
Zimmer, Inc. is recalling specific Total Ankle Talar Components due to potential elevated levels of manufacturing residue on the implants.
Product
Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0468-2014·2013-12-18
Arrow Transradial Artery Access Products Recalled for Occluded Needles
Arrow International Inc is recalling Transradial Artery Access products because introducer needles may be occluded, posing a risk of delayed treatment or adverse events.
Product
Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0489-2014·2013-12-18
GE Healthcare Patient Monitors Recalled for Incorrect ECG Filter Settings
GE Healthcare is recalling specific patient monitors because they may apply an incorrect ECG filter setting if impedance respiration is enabled at startup.
Product
HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0466-2014·2013-12-18
Maquet Vasoview Hemopro Endoscopic Vessel Harvesting System Recalled for Overheating
Maquet Cardiovascular is recalling 12,259 units of the Vasoview Hemopro Endoscopic Vessel Harvesting System due to complaints that the device self-activates or overheats.
Product
Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 Indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0462-2014·2013-12-18
Zimmer NexGen Knee Instruments Recalled Due to Surgical Delay Risk
Zimmer, Inc. is recalling five NexGen knee instruments to prevent their inadvertent use during surgery, which could cause delays.
Product
NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0484-2014·2013-12-18
Trumpf Medical Systems Recalls Helion S and H300 Exam Lights
Trumpf Medical Systems is recalling 287 Helion S and H300 exam lights because a plastic joint may fail due to fatigue after seven years of use.
Product
Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice.
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0457-2014·2013-12-18
Hospira Recalls Receptal Canisters Due to Suction Failure
Hospira is recalling 1L Receptal Canisters because the canister and liner may not seat properly, preventing the creation of necessary suction.
Product
Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China; Hospira, Inc.,; Lake Forest, IL 60045 USA. Used to isolate suction waste during surgeries, or to clear patient airways, throat or wounds to allow treatment.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0460-2014·2013-12-18
Zimmer NexGen Porous Patella Drill Guide Recall Expansion
Zimmer, Inc. is expanding a recall of NexGen Porous Patella Drill Guides to prevent inadvertent use during surgery, which could cause delays.
Product
NexGen Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm thickness Non sterile, Rx Only Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0464-2014·2013-12-18
Centurion Sterile Rubber Bands Recalled for Contradictory Latex Labeling
Centurion Medical Products is recalling sterile rubber bands that are labeled as both latex-free and containing natural rubber latex, posing a risk to users with latex allergies.
Product
Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural rubber latex which may cause allergic reactions. LATEX FREE , CAUTION: FEDERAL lAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Single Use Only bands items…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0479-2014·2013-12-18
Aesculap GNI161 Bipolar Foot Control Recalled for Energy Failure
Aesculap, Inc. is recalling 85 GNI161 Bipolar Foot Controls because the bipolar energy did not stop after the foot control was released.
Product
Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0461-2014·2013-12-18
Zimmer NexGen Knee Implant Components Recalled for Surgical Delay Risk
Zimmer, Inc. is recalling 638 NexGen Complete Knee Solution provisional articular surface devices. The recall is an expansion of a previous action to prevent inadvertent use of associated instruments.
Product
NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0459-2014·2013-12-18
Zimmer NexGen Porous Patella Drill Guide Recall Expansion
Zimmer, Inc. is expanding a recall of NexGen Porous Patella Drill Guides to include five additional instruments. These devices may be inadvertently used during surgery, causing delays.
Product
NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickness Non sterile, Rx Only Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0478-2014·2013-12-18
Steris Recalls AMSCO Evolution Steam Sterilizer Transfer Carriages
Steris Corporation is recalling 936 AMSCO Evolution steam sterilizer transfer carriages because they may unlatch when overloaded or maneuvered with excessive force.
Product
AMSCO¿ Evolution¿ steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transportation unit utilized to carry, load, & unload the Loading Car into and out of steam sterilizer units.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0463-2014·2013-12-18
Zimmer NexGen Knee Instruments Recalled Due to Potential Surgical Delay
Zimmer, Inc. is recalling five NexGen Micro knee instruments because they may be used incorrectly, causing surgical delays.
Product
NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0480-2014·2013-12-18
Zimmer Recalls NexGen Knee Components Due to Stem Locking Failure
Zimmer, Inc. is recalling 128 NexGen Complete Knee Solutions Stemmed Tibial Components because the stem may not lock into the tibia.
Product
NexGen¿ Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. The device is indicated for patients with severe knee pain and disability due to: Rheumatoid…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0465-2014·2013-12-18
Karl Storz Recalls Misidentified Axillent Debakey Grasping Forceps
Karl Storz is recalling 7 units of Axillent Debakey Grasping Forceps because they were mislabeled as a different model.
Product
Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissue.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0469-2014·2013-12-18
Omnyx Digital Pathology Software Recalled for Incorrect Measurement Display
Omnyx LLC is recalling Digital Pathology System (DPS) Software version 1.1 because its annotation tools may display incorrect measurements and area calculations for regions of interest on scanned slides.
Product
Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0482-2014·2013-12-18
Accumetrics Recalls VerifyNow IIb/IIIa Test Kits Due to Incorrect Instructions
Accumetrics is recalling VerifyNow IIb/IIIa Test Kits because they contain incorrect instructions regarding the time limit for performing the test after sample collection.
Product
VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total tests. The VerifyNow IIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0467-2014·2013-12-18
Stryker Recalls Accolade II Hip Stems Due to Packaging Error
Stryker is recalling 20 Accolade II Hip Stems because a Size #3 was found packaged with a Size #5. The error poses a risk of incorrect implant selection.
Product
1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0471-2014·2013-12-18
Beckman Coulter Recalls LH 750 and LH 780 Hematology Systems
Beckman Coulter is recalling LH 750 and LH 780 Hematology Systems because optical degradation may delay reporting results for specific blood cell counts.
Product
Coulter LH 780 Hematology Analyzer, Part No. 723585, A90728 Product Usage: Coulter LH 780 Hematology Analyzer is a is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter¿ LH 780…
Category
Medical Device
Distribution
Distributed nationwide

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36951–36975 of 40449