Browse Device Recalls

2,093 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,093 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 2,093 FDA device recalls in NJ.

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DateProductReasonClassFirm
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.
Oct 24, 2017 radial head 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 rHead Stem Implant Plasma Coated, Size 4. 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 Radio Capitellum, Recon Head, Size #2. 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 Radio Capitellum Large, Left Orthopedic implant for replacement of the prox... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 #2 Bipolar radial head Implant (Sterile packed). 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 2. 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 rHead Recon Extended Stem Size 1. 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 rHead Standard Extended Stem, 6mm Collar, 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 Lateral Assembly, Radial Head 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 rHead Stem Implant 6mm Collar, Size 4.Orthopedic implant for replacement of t... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 #3 Bipolar radial head Implant (Sterile packed). 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 Plasma Coated, Size 2. 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 Radio Capitellum, Recon Head, Size #4. 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 rHead, Radial Implant 6 mm Collar, Size 4. Orthopedic implant for replacemen... 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.