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

33151–33175 of 40325

ModerateFDA (Devices)·Z-1503-2015·2015-04-29
Specialty Appliance Works Recalls Orthodontic Universal Nuts Due to Material Error
Specialty Appliance Works is recalling 14,428 Universal Nuts used in orthodontic Herbst Appliances because they were manufactured with 416 SS instead of the specified 303 SS.
Product
MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient Kit A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1512-2015·2015-04-29
Xpress System Pedicle Screw Assembly Recalled for Incorrect Laser Marking
X Spine Systems Inc is recalling 14 units of Xpress System Pedicle Screw Assemblies because the laser marking on the yoke incorrectly states 7.5 x 55mm instead of 5.5 x 55mm.
Product
Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-1509-2015·2015-04-29
Specialty Appliance Works Recalls Orthodontic Universal Nut Components
Specialty Appliance Works is recalling Universal Nut components for Herbst Appliances because they were made with 416 SS instead of the specified 303 SS.
Product
TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component 6UR (5/pk), TS Crown Component 4LR (5/pk), TS Crown Component 5LR (5/pk), TS Crown Component 6LR (5/pk), TS Crown Component 4UL (5/pk), TS Crown Component 5UL (5/pk), TS Crown Component 4LL (5/pk)…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1466-2015·2015-04-29
Biomet Recalls Torque Limiting Handles for Spinal Fixation Devices
Biomet Spine is recalling 874 Torque Limiting Handles used in spinal fixation due to supplier component updates.
Product
Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1505-2015·2015-04-29
Specialty Appliance Works Recalls MiniScope Mechanical Set Universal Nuts
Specialty Appliance Works is recalling Universal Nuts for MiniScope Mechanical Sets because they were made with 416 stainless steel instead of the specified 303 stainless steel.
Product
Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21, and Specialty MiniScope Mech. Set Size 24 A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1502-2015·2015-04-29
Herbst Universal Nut Recalled for Incorrect Stainless Steel Material
Specialty Appliance Works is recalling Herbst Universal Nuts because they were manufactured with 416 SS instead of the specified 303 SS.
Product
Herbst Universal Nut which is used in a Herbst Appliance A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1504-2015·2015-04-29
Specialty Appliance Works Recalls Orthodontic Herbst Appliance Nuts
Specialty Appliance Works is recalling TS Herbst Nuts because they were manufactured with 416 stainless steel instead of the specified 303 stainless steel.
Product
TS Herbst Nuts with Backing (10/pk) and TS Herbst Nuts Universal (10/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1511-2015·2015-04-29
Specialty Appliance Works Recalls Orthodontic Universal Nut Components
Specialty Appliance Works is recalling TS ROC Crown Components because the Universal Nut was made with 416 SS instead of the specified 303 SS.
Product
TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk), TS ROC Crown Component 8UR (5/pk), TS ROC Crown Component 4LR (5/pk), TS ROC Crown Component 5LR (5/pk), TS ROC Crown Component 6LR (5/pk)…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1508-2015·2015-04-29
Specialty Appliance Works Recalls Universal Nuts for Herbst Appliances
Specialty Appliance Works is recalling Universal Nuts used in Herbst orthodontic appliances because they were made with 416 stainless steel instead of the specified 303 stainless steel.
Product
LR Telescoping Cantilever Arms (5/pk) and LL Telescoping Cantilever Arms (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1481-2015·2015-04-29
Catheter Research Recalls Mislabeled HSG Trays and Catheters
Catheter Research, Inc. is recalling 880 HSG trays and catheters because the flexible and shapeable catheters were mislabeled on the packaging.
Product
HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-1506-2015·2015-04-29
Specialty Appliance Works Recalls Universal Nuts for Incorrect Material Composition
Specialty Appliance Works is recalling Universal Nuts used in orthodontic Herbst Appliances because they were manufactured with 416 stainless steel instead of the specified 303 stainless steel.
Product
M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1465-2015·2015-04-29
Biomet Recalls Lineum HF Torque Handle Limit Due to Component Updates
Biomet Spine is recalling 148 Lineum HF Torque Handle Limit units because the supplier withdrew the product for component updates or reconfiguration.
Product
Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facilitate reconstruction of the cervical and upper thoracic spine using bones screws, locking plugs, and various types of rods, hooks, and lateral connectors.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1507-2015·2015-04-29
Specialty Appliance Works Recalls Universal Nuts for Orthodontic Appliances
Specialty Appliance Works is recalling Universal Nuts for orthodontic Herbst Appliances because they were made with 416 stainless steel instead of the specified 303 stainless steel.
Product
HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 and HTH Mechanism Set Size 24 A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1479-2015·2015-04-29
SpineFrontier Recalls MISquito Pedicle Screw System Surgical Technique Document
SpineFrontier is recalling the MISquito Pedicle Screw System Surgical Technique document because it does not adequately convey the intended use of the Rod Caliper.
Product
SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1449-2015·2015-04-22
Hansen Medical Recalls Magellan Robotic Systems Due to Catheter Retraction Defect
Hansen Medical is recalling 19 Magellan Robotic Systems because the catheter may fail to stop retracting when the control button is released.
Product
Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1441-2015·2015-04-22
GE Healthcare Recalls Improperly Installed Ceiling Suspended Radiation Shields
GE Healthcare is recalling 797 ceiling-suspended pendent systems for radiation shields and surgical lamps due to improper installation. One incident of a shield falling and causing a minor injury has been reported.
Product
Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1451-2015·2015-04-22
Baxter SIGMA Spectrum Infusion Pump Software Recall for Dose Display Discrepancy
Baxter is recalling SIGMA Spectrum Infusion Pump software due to a discrepancy between Master Drug Library settings and pump display, which may cause therapy delays or unintended delivery rates.
Product
Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled…
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-1442-2015·2015-04-22
Baylis Medical Recalls ProTrack Microcatheter Due to Circumferential Shaft Defects
Baylis Medical Corp is recalling two lots of ProTrack Microcatheters due to potential circumferential defects along the device shaft.
Product
ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1443-2015·2015-04-22
Bard PICC and Dialysis Catheter Kits Recalled for Scalpel Injury Risk
Bard Access Systems is recalling PICC and dialysis catheter kits containing Safe-Cut Safety Scalpels due to the potential for inadvertent scalpel stick injuries.
Product
Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1453-2015·2015-04-22
US Endoscopy Recalls Talon Grasping Devices Due to Detached Wire Component
US Endoscopy Group Inc is recalling 1,695 Talon Grasping Devices because a wire component on the distal grasping assembly became detached.
Product
Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract.
Category
Medical Device
Distribution
42 states
HighFDA (Devices)·Z-1447-2015·2015-04-22
Bard Monopty Disposable Core Biopsy Instruments Recalled for Activation Issues
Bard Peripheral Vascular is recalling specific Bard Monopty Disposable Core Biopsy Instruments and Kits due to potential activation-related issues.
Product
Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biopsy, Product Code: 000441; Monopty 14g x 10cm (22mm), Product Code: 121410; Monopty 14g x 10cm (11mm), Product Code: 211410. The BARD MONOPTY Disposable Core…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1450-2015·2015-04-22
CooperSurgical Recalls Wallach LL 100 Cryosurgical Units Due to Gas Line Burst Risk
CooperSurgical is recalling 255 Wallach LL 100 cryosurgical units because an internal gas line may malfunction and burst under pressure.
Product
WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1413-2015·2015-04-22
Bard ConQuest PTA Balloon Dilatation Catheter Recalled for Deflation Risk
Bard Peripheral Vascular is recalling specific lots of the ConQuest PTA Balloon Dilatation Catheter due to a risk of deflation-related issues.
Product
Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1444-2015·2015-04-22
Hardy Diagnostics Recalls HardyCHROM SS Agar Due to Color Development Issue
Hardy Diagnostics is recalling HardyCHROM SS Agar (Lot 15037) due to a report of possible lack of color development in Shigella organisms.
Product
Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2 to 8 degrees C. on receipt in dark A selective chromogenic medium for the primary screening…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1435-2015·2015-04-22
Nobel Biocare Recalls Dental Implants Due to Packaging Material Issue
Nobel Biocare is recalling 216 units of NobelReplace CC PMC NP dental implants because packaging material may leave a sticky substance on the implant surfaces.
Product
NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287.
Category
Medical Device
Distribution
Distributed nationwide

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33151–33175 of 40325