Browse Device Recalls
2,057 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,057 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 2,057 FDA device recalls in NJ.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 21, 2017 | Custom Made Implant System with Minimum Invasive Grower (MIG) component | From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to cl... | Class II | Howmedica Osteonics Corp. |
| Dec 20, 2017 | The humeral stems trials are packaged in a kit for Titan Modular Shoulder Sys... | Incidents of stem trial breakage were reported to the firm suggesting that these fractures all oc... | Class II | Integra LifeSciences Corp. |
| Dec 18, 2017 | Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size:... | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in... | Class II | Johnson & Johnson Consumer, Inc. |
| Dec 18, 2017 | COACH¿ Self-Adhering Sports Wrap (size: 3in) | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in... | Class II | Johnson & Johnson Consumer, Inc. |
| Dec 18, 2017 | Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 1in) | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in... | Class II | Johnson & Johnson Consumer, Inc. |
| Dec 18, 2017 | Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 2in) | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in... | Class II | Johnson & Johnson Consumer, Inc. |
| Dec 18, 2017 | Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size:... | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in... | Class II | Johnson & Johnson Consumer, Inc. |
| Dec 18, 2017 | COACH¿ Self-Adhering Sports Wrap (size: 2in) | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in... | Class II | Johnson & Johnson Consumer, Inc. |
| Dec 4, 2017 | Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 0456014194... | There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke m... | Class II | Konica Minolta Medical Imaging USA, Inc. |
| Dec 4, 2017 | Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 0456014194... | There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke m... | Class II | Konica Minolta Medical Imaging USA, Inc. |
| Dec 4, 2017 | Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 0456014... | There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke m... | Class II | Konica Minolta Medical Imaging USA, Inc. |
| Dec 4, 2017 | Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 0456014194... | There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke m... | Class II | Konica Minolta Medical Imaging USA, Inc. |
| Dec 1, 2017 | Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usa... | The firm made multiple changes to the product requiring the submission of a new 510(k) premarket ... | Class III | Mindray DS USA, Inc. dba Mindray North America |
| Nov 27, 2017 | DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO ... | Ethicon discovered that specific lots of DERMABOND"PRINEO"System may not dry within the specified... | Class II | Ethicon, Inc. |
| Nov 16, 2017 | ALM XTEN Surgical Light intended to provide visible illumination for the surg... | Getinge has received complaints concerning the X TEN Surgical Lights whose spring arms have broke... | Class II | GETINGE US SALES LLC |
| Oct 27, 2017 | Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes.... | The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for... | Class II | Roche Molecular Systems, Inc. |
| Oct 25, 2017 | Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated de... | Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (de... | Class II | Diagnostica Stago, Inc. |
| Oct 25, 2017 | STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated d... | Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (de... | Class II | Diagnostica Stago, Inc. |
| Oct 25, 2017 | Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated d... | Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (de... | Class II | Diagnostica Stago, Inc. |
| Oct 25, 2017 | STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automa... | Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (de... | Class II | Diagnostica Stago, Inc. |
| Oct 24, 2017 | rHead Recon Stem Implant Plasma Coated, Size 1. Orthopedic implant for replac... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead, Radial Implant 6 mm Collar, Size 1. Orthopedic implant for replacemen... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Recon Stem Implant 6mm Collar, Size 4. Orthopedic implant for replaceme... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Radio Capitellum Small, Right. Orthopedic implant for replacement of the pro... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Standard Extended Stem, 6mm Collar, Size 1. Orthopedic implant for rep... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead, Radial Implant 6 mm Collar, Size 3. Orthopedic implant for replacemen... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Lat Assembly, Rad Stem Implant,Collar 6mm,Size 3. Orthopedic implant for repl... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Stem Implant Plasma Coated, Size 1. Orthopedic implant for replacement ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Recon Stem Implant 6mm Collar, Size 2. Orthopedic implant for replaceme... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Recon Extended Stem Size 2. Orthopedic implant for replacement of the ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | radial stem implant #2 (Sterile packed). Orthopedic implant for replacement ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Stem Implant 6mm Collar, Size 3. Orthopedic implant for replacement of ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement o... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Lateral Assembly, Radial Stem Implant, Size 4. Orthopedic implant for replace... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Lateral Assembly, Radial Stem Implant, Size 3. Orthopedic implant for replace... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Lat Assembly, Rad Stem Implant,Collar 6mm,Size 4. Orthopedic implant for repl... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | radial head implant #2 (Sterile packed). Orthopedic implant for replacement ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Radial Head Assy Size #2, Rad. Orthopedic implant for replacement of the pro... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Radial Head Assy Size #3, Rad. Orthopedic implant for replacement of the pro... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Lat Assembly, Rad Stem Implant,Collar 6mm, Size1. Orthopedic implant for repl... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Recon Stem Implant non-coated, Size 3. Orthopedic implant for replacem... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | radial stem implant #4 (Sterile packed). Orthopedic implant for replacement ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | radial head implant #3 (Sterile packed). Orthopedic implant for replacement ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Standard Extended Stem, 6mm Collar, Size 3. Orthopedic implant for rep... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Lateral Assembly, Radial Stem Implant, Size 2. Orthopedic implant for replace... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Stem Implant 6mm Collar, Size 1. Orthopedic implant for replacement of ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Lateral Assembly, Radial Head Implant, Size 2. Orthopedic implant for replace... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Recon Stem Implant non-coated, Size 4. Orthopedic implant for replaceme... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.