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

38351–38375 of 40449

ModerateFDA (Devices)·Z-1379-2013·2013-06-05
Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Implants
Orthopedic Alliance LLC is recalling loaner bins and sterilization trays for orthopedic implants and instruments because directions for use and surgical techniques were not provided to every physician for every surgery.
Product
Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemented,#3 2203-3030 Tibial baseplate,cemented,#4 2203-3040 Tibial baseplate, cemented, #5 2203-3050 Tibial baseplate, cemented, #6 2203-3060 Tibial insert,CR,plained,#1,9mm…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1380-2013·2013-06-05
Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays
Orthopedic Alliance LLC is recalling 57 units of loaner bins and sterilization trays because surgical instructions were not provided to every physician.
Product
UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE Patella,X-large 2401-1040 UKNEE Onset Patella, 3 pegs, x-small 2403-1010 UKNEE Onset Patella, 3 pegs, small 2403-1020 UKNEE Onset Patella, 3 pegs, medium 2403-1030 UKNEE…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1425-2013·2013-06-05
Intuitive Surgical Recalls Tip Cover Accessories for Labeling Clarification
Intuitive Surgical is recalling 50,000 boxes of Tip Cover Accessories for the da Vinci Surgical System to clarify existing labeling and related cautions.
Product
Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1392-2013·2013-06-05
Stryker Orthobiologics Aliquot Catheter Recall for Use Error Revision
Stryker Orthobiologics is recalling 27 Aliquot Catheters to revise instructions after reported breakage during vertebroplasty procedures.
Product
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1394-2013·2013-06-05
Stryker Orthobiologics Aliquot Diamond Needle Recall for Catheter Breakage
Stryker Orthobiologics is recalling 19 units of the Aliquot Diamond Needle due to reported catheter breakage during vertebroplasty procedures.
Product
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, 4", Part Number 2110-0506 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1391-2013·2013-06-05
Stryker Orthobiologics Aliquot Beveled Needle Recalled for Catheter Breakage
Stryker Orthobiologics is recalling 35 units of the Aliquot Beveled Needle because the catheter may break during removal. The issue is attributed to user error, and the correction involves updating the Directions for Use.
Product
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1407-2013·2013-06-05
Alpine Biomed Recalls Natus Dantec KEYPOINT.NET Software Due to Bug
Alpine Biomed Aps is recalling Natus neurology Dantec KEYPOINT.NET version 2.20 software due to a software bug. The recall affects 871 installed licenses distributed worldwide.
Product
Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502, 9033A071103, 9033A072102, 9031A070102, 9033A007402, 9033A071102, 9033A072103, 9033A0701, 9033A0711HA, 9033A071101, 9031A070101, 9031A006401, 9031A006501, 9033A004701, 9031A0032…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1377-2013·2013-06-05
Anspach Effort 3mm Diamond Ball Burrs Recalled for Grit Size Defect
The Anspach Effort, Inc. is recalling 1,827 3mm Diamond Ball burrs because three batches may have diamond grit larger than intended.
Product
***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1396-2013·2013-06-05
Stryker Orthobiologics Aliquot Reamer Recalled for Catheter Breakage
Stryker Orthobiologics is recalling 7 units of the Aliquot Reamer, 6" (Part Number 2110-0504) because the catheter may break during removal from the needle.
Product
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1411-2013·2013-06-05
Spinal Solutions Recalls Set Screws Due to Missing Surgical Instructions
Spinal Solutions is recalling 106 Set Screws (Item #BG3010) because directions for use and surgical techniques were not provided to every physician.
Product
Set Screw, Item #BG3010 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1423-2013·2013-06-05
Becton Dickinson Recalls BBL DrySlide Oxidase Kits Due to Packaging Error
Becton Dickinson is recalling BBL DrySlide Oxidase Kits because they were placed in incorrect packaging for distribution to laboratories.
Product
BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic aid for gram-negative bacteria.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1390-2013·2013-06-05
Stryker Orthobiologics Aliquot Delivery System Recalled for Catheter Breakage
Stryker Orthobiologics is recalling 155 units of the Aliquot Syringe Delivery System because the catheter may break during removal from the needle.
Product
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1400-2013·2013-06-05
Beckman Coulter Recalls Lactate Reagent Due to Error Messages
Beckman Coulter is recalling Lactate Reagent Lot M206209 because it may fail to report numerical values for high lactate concentrations.
Product
Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator, is intended for the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1428-2013·2013-06-05
Intuitive Surgical Recalls da Vinci Flush Ports for Labeling Clarification
Intuitive Surgical is recalling da Vinci instrument flush ports to clarify existing labeling and operating procedures.
Product
Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1413-2013·2013-06-05
Spinal Solutions Recalls 50 mm Rods Due to Missing Surgical Instructions
Spinal Solutions is recalling 55 units of 50 mm Rods because directions for use and surgical techniques were not provided to every physician.
Product
50 mm Rod, Item #BG1650 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1375-2013·2013-06-05
Intel-GE QuietCare Recall Issued for Duplicate Alert Functionality
Intel-GE Care Innovations LLC is recalling QuietCare monitoring systems because customers reported receiving duplicate alerts. The recall affects 1,722 units distributed in the US and Great Britain.
Product
QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1382-2013·2013-06-05
Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions
Orthopedic Alliance LLC is recalling 21 loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.
Product
Femoral head, standard, ¿26mm, +0mm Femoral head,medium, ¿26mm,+3mm Femoral head, long, ¿26mm, +6mm Femoral head, X-long, ¿26mm, +9mm Femoral head, ¿28mm, -3mm Femoral head, ¿28mm, +0mm Femoral head, ¿28mm, +5mm Femoral head, ¿28mm, +10mm Femoral head, ¿32mm, -3mm…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1417-2013·2013-06-05
Spinal Solutions Recalls Copperhead IBFD Loaner Bins Due to Missing Instructions
Spinal Solutions is recalling Copperhead IBFD loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.
Product
Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead IBFD, Large Neutral, 8mm Copperhead IBFD, Large Neutral, 9mm Copperhead IBFD, Large Neutral, 10mm Copperhead IBFD, Large Neutral, 11mm Product Usage: Spinal Solutions distributes a…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1386-2013·2013-06-05
Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions
Orthopedic Alliance LLC is recalling 26 loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician for every surgery.
Product
Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short CERAMIC Ball Head, 32 Medium CERAMIC Ball Head, 32 Long CERAMIC Ball Head, 28 Short CoCr Ball Head, 28 Medium CoCr Ball Head, 28 Long CoCr Ball Head, 28 X-Long CoCr…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1414-2013·2013-06-05
Spinal Solutions Recalls 60 mm Rods Due to Missing Surgical Instructions
Spinal Solutions is recalling 72 units of 60 mm Rods because directions for use and surgical techniques were not provided to every physician.
Product
60 mm Rod, Item #BG1660 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1412-2013·2013-06-05
Spinal Solutions Recalls 40 mm Rods Due to Missing Surgical Instructions
Spinal Solutions is recalling 63 units of 40 mm Rods because directions for use and surgical techniques were not provided to every physician.
Product
40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1381-2013·2013-06-05
Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Documentation Issues
Orthopedic Alliance LLC is recalling 30 units of loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.
Product
U2 Acetabular cup, Ti beads porous coated, ¿44mm U2 Acetabular cup, Ti beads porous coated, ¿46mm U2 Acetabular cup, Ti beads porous coated, ¿48mm U2 Acetabular cup, Ti beads porous coated, ¿50mm U2 Acetabular cup, Ti beads porous coated, ¿52mm U2 Acetabular cup, Ti beads…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1429-2013·2013-06-05
Intuitive Surgical da Vinci Si Surgeon Console Labeling Clarification
Intuitive Surgical is clarifying labeling and operating procedures for the da Vinci Si Surgeon Console to ensure accurate control of endoscopic instruments.
Product
da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1426-2013·2013-06-05
Intuitive Surgical Recalls Unapproved da Vinci Thyroidectomy Promotional Literature
Intuitive Surgical is recalling promotional literature for the da Vinci Surgical System's thyroidectomy indication because the use was not approved with a 510(k) change.
Product
Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1350-2013·2013-05-29
Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes
Progressive Medical is recalling PTFE Coated Disposable Electrosurgical Electrodes because the product coatings require 510K approval.
Product
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 33cm Length, Product number P0020, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in…
Category
Medical Device
Distribution
Distributed nationwide

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38351–38375 of 40449