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

29651–29675 of 40325

ModerateFDA (Devices)·Z-2158-2016·2016-07-20
Synthes Recalls 3.5 mm and 4.0 mm Cannulated Screws for Labeling Errors
Synthes (USA) Products LLC is recalling 3.5 mm and 4.0 mm Cannulated Screws because the labeling does not match the cleared indications for use in the United States and Canada.
Product
3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D029094, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2189-2016·2016-07-20
Synthes Low Profile Neuro Screwdriver Blade Recalled for MR Safety Labeling
Synthes (USA) Products LLC is recalling 50 units of Low Profile Neuro Screwdriver Blades because the MR Safety information etched or labeled on the devices does not meet current ASTM standards.
Product
Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short Lot # 5053859 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2199-2016·2016-07-20
Synthes 1.1mm Drill Bit Recalled for Incorrect MR Safety Labeling
Synthes (USA) Products LLC is recalling 19 units of 1.1mm Drill Bits because their MR safety labeling does not meet current ASTM standards.
Product
Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2159-2016·2016-07-20
Merge OfficePACS Software Recalled for Potential Data Loss
Merge Healthcare is recalling OfficePACS software version 3.4 because archiving failures may cause data loss at 49 medical facilities.
Product
Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
Category
Medical Device
Distribution
23 states
ModerateFDA (Devices)·Z-2195-2016·2016-07-20
Synthes Recalls 34 Stardrive Screwdrivers for MR Safety Labeling Errors
Synthes (USA) Products LLC is recalling 34 units of 1.3mm Stardrive Screwdrivers because their MR Safety labeling does not meet current ASTM standards.
Product
Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2191-2016·2016-07-20
Synthes Recalls Matrix Neuro Screwdriver Blades for MR Safety Labeling Errors
Synthes (USA) Products LLC is recalling 18 Matrix Neuro Screwdriver Blades because their MR safety labeling does not meet current ASTM standards.
Product
Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220, mfg 7/18/2007 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2153-2016·2016-07-20
Synthes 6.5 mm Cancellous Screw Recalled for Labeling Mismatch
Synthes (USA) Products LLC is recalling 6.5 mm Cancellous Screws because the labeling does not match the cleared indications for use in the United States and Canada.
Product
6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2156-2016·2016-07-20
Synthes 4.5 mm Cortex Screw Recalled for Labeling Mismatch
Synthes (USA) Products LLC is recalling 4.5 mm Cortex Screws because the labeling does not match the cleared indications for use in the United States and Canada.
Product
4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2197-2016·2016-07-20
Synthes Recalls 2.0mm Stardrive Screwdrivers for MR Safety Labeling Errors
Synthes (USA) Products LLC is recalling 79 units of 2.0mm Stardrive Screwdrivers because their MR Safety labeling does not meet current ASTM standards.
Product
Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341036, 4363819, 4427699, mfg. 3/4/2002-6/6/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2192-2016·2016-07-20
Synthes Recalls Matrix Neuro Screwdriver Blades for MR Safety Labeling Errors
Synthes (USA) Products LLC is recalling 18 Matrix Neuro Screwdriver Blades because their MR Safety labeling does not meet current ASTM standards.
Product
Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & UR80162, mfg 7/18/2007-8/2/2007 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2196-2016·2016-07-20
Synthes Recalls 1.5mm Stardrive Screwdrivers for Incorrect MR Safety Labeling
Synthes (USA) Products LLC is recalling 383 units of 1.5mm Stardrive Screwdrivers because their MR Safety information does not meet current ASTM standards.
Product
Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904305, 4427700,4589568, 4830581, 4532370, 4673943, 4871657, mfg. 2/12/2002-5/23/2005 Product Usage: The DePuy Synthes MR Safe Instruments…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2193-2016·2016-07-20
Synthes Recalls Surgical Handles for Incorrect MR Safety Labeling
Synthes (USA) Products LLC is recalling 29 surgical handles because their MR safety labels do not meet current ASTM standards.
Product
Part #311.039, Handle with Mini QC Small, Lot # 4401497, 4687440, 4687441, 5639684, 4415131,4663839, 5623098 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2201-2016·2016-07-20
Arrow Recalls Femoral Arterial Catheterization Kits Due to Labeling Error
Arrow International Inc is recalling 50 femoral arterial catheterization kits because some shipping cartons contained the wrong product model.
Product
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2157-2016·2016-07-20
Synthes Recalls 4.5 mm Cannulated Screws Due to Labeling Errors
Synthes (USA) Products LLC is recalling 4.5 mm Cannulated Screws because the labeling does not match the cleared indications for use in the United States and Canada.
Product
4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2155-2016·2016-07-20
Synthes 4.0 mm Cortex Screw Recalled for Labeling Mismatch
Synthes (USA) Products LLC is recalling 4.0 mm Cortex Screws because the labeling does not match the cleared indications for use in the United States and Canada.
Product
4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2203-2016·2016-07-20
Roche Recalls Influenza Quality Control Kits Due to Incorrect Expiration Dates
Roche Molecular Systems is recalling 194 cobas Liat Influenza A/B Quality Control Kits because they are labeled with incorrect expiration dates.
Product
cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
Category
Medical Device
Distribution
16 states
LowFDA (Devices)·Z-2143-2016·2016-07-20
Ortho-Clinical enGen Laboratory Automation System Software Recall
Ortho-Clinical Diagnostics is recalling 30 enGen Laboratory Automation Systems due to a software error that displays incorrect interpretive text for certain test results.
Product
enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2145-2016·2016-07-20
Ortho VITROS AFP Reagent Pack Recall Due to Calibration Failure
Ortho Clinical Diagnostics is recalling specific lots of VITROS AFP Reagent Packs because they may fail to calibrate, potentially affecting test results.
Product
VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2122-2016·2016-07-13
Medtronic Recalls Cytosponge Cell Collection Kits Due to Detachment Reports
Medtronic is recalling Cytosponge Cell Collection Kits after two reports of the device detaching from the removal string during withdrawal from the esophagus.
Product
Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. Item code CYTO-KIT-R Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the…
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-1908-2016·2016-07-13
Hummingbird Med Recalls Hummi Micro Draw Blood Transfer Devices
Hummingbird Med is recalling 62,400 Hummi Micro Draw Blood Transfer Devices distributed in California due to insertion difficulties.
Product
ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection from peripheral arterial line catheters.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2134-2016·2016-07-13
Karl Storz Image1 SPIES X-LINK Camera Control Unit Recall
Karl Storz Endoscopy is recalling Image1 SPIES X-LINK Camera Control Units due to potential electrical interference when used with specific camera heads and mediastinoscopes.
Product
Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116 & TH115, and DC1 Video Mediastinoscope
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-2124-2016·2016-07-13
Esaote G-scan Brio MRI System Recalled for Table Fracture Risk
Esaote S.p.A. is recalling G-scan Brio MRI systems because dynamic loading forces from larger patients can fracture the patient table's extremity portion.
Product
Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2131-2016·2016-07-13
GE Healthcare Recalls Discovery MR750w MRI Scanners Due to Burn Risk
GE Healthcare is recalling 471 Discovery MR750w MRI scanners because a small area of the patient bore can become warm enough to cause a serious burn if proper padding is not used.
Product
GE Healthcare, Discovery MR750w
Category
Medical Device
Distribution
38 states
HighFDA (Devices)·Z-2129-2016·2016-07-13
Medtronic PoleStar MRI System Components Recalled for Electrical Shock Risk
Medtronic Navigation is recalling PoleStar MRI system components due to misplaced ground pins that may cause electrical shock to users.
Product
PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller Product The PoleStar Surgical MRI System is intended for use as an intraoperative imaging device to produce MRI images of sections of the head selected by the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2082-2016·2016-07-13
Medtronic 0-arm Imaging mobile x-ray system recall for battery damage risk
Medtronic is recalling 0-arm Imaging mobile x-ray systems because replacement batteries may be damaged during shipment, creating a risk of failure.
Product
Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028
Category
Medical Device
Distribution
Distributed nationwide

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