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

29726–29750 of 40449

HighFDA (Devices)·Z-2184-2016·2016-07-20
Stryker Target Nano Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.
Product
Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035452560 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2168-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may have reduced their stretch resistance, potentially leading to increased coil stretching.
Product
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL Number:M0035431510 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2204-2016·2016-07-20
Stryker Recalls 5.0mm Round Fluted Burs Due to Corrosion Risk
Stryker Instruments is voluntarily recalling specific lots of 5.0mm Round Fluted Burs because tarnishing or corrosion may cause inflammation requiring surgery.
Product
5.0mm Round Fluted Bur, Super Long
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2161-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.
Product
Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number: M0035421030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2167-2016·2016-07-20
Stryker Target Nano Coils Recalled for Reduced Stretch Resistance
Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may have reduced their stretch resistance, potentially leading to increased coil stretching.
Product
Target Detachable Coils: TARGET HELICAL NANO 1 MM X 3 CM MODEL Number:M0035431030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2190-2016·2016-07-20
Synthes Recalls Neuro Screwdriver Blades for Incorrect MR Safety Labeling
Synthes (USA) Products LLC is recalling 26 neuro screwdriver blades because their MR safety labels do not meet current ASTM standards.
Product
Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, Lot # 5053374, mfg 7/27/2005 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-2202-2016·2016-07-20
Arrow Femoral Arterial Line Catheterization Kit Recalled for Labeling Error
Arrow International Inc. is recalling 50 units of Femoral Arterial Line Catheterization Kits due to shipping carton labeling errors.
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-2152-2016·2016-07-20
Synthes 6.5 mm Cannulated Screw Recalled for Labeling Mismatch
Synthes (USA) Products LLC is recalling 6.5 mm Cannulated Screws because the labeling does not match the cleared indications for use in the United States and Canada.
Product
6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, 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-2198-2016·2016-07-20
Synthes Recalls 2.0mm Stardrive Screwdriver for Incorrect MR Safety Labeling
Synthes (USA) Products LLC is recalling 36 units of 2.0mm Stardrive Screwdrivers because their MR safety labeling does not meet current ASTM standards.
Product
Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2002 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-2154-2016·2016-07-20
Synthes Recalls 7.0 mm and 7.3 mm Cannulated Screws for Labeling Errors
Synthes (USA) Products LLC is recalling 7.0 mm and 7.3 mm Cannulated Screws because the labeling does not match the cleared indications for use in the United States and Canada.
Product
7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D068620, Plate, 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-2144-2016·2016-07-20
Merge Healthcare Recalls OfficePACS Software Due to Data Loss Risk
Merge Healthcare is recalling OfficePACS software versions 4.0 through 4.2 because a defect in the archiving function may cause potential data loss.
Product
Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2194-2016·2016-07-20
Synthes Recalls 1.3mm Stardrive Screwdrivers for Incorrect MR Safety Labeling
Synthes (USA) Products LLC is recalling 75 units of 1.3mm Stardrive Screwdrivers because their MR Safety labeling does not meet current ASTM standards.
Product
Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 4427697, mfg. 2/28/2002-6/6/2002 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-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

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29726–29750 of 40449