Browse Device Recalls
4,606 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,606 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 4,606 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 20, 2013 | HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400IS... | HORIBA Medical is informing all ABX PENTRA 400 Analyzer with I.S.E. Module customers that there a... | Class II | Horiba Instruments, Inc dba Horiba Medical |
| Mar 19, 2013 | Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Med... | A defect on the master-side connector block of the pneumatic tool changer could introduce a tilt ... | Class II | Accuray Incorporated |
| Mar 18, 2013 | TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02... | Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The b... | Class II | Loma Vista Medical |
| Mar 18, 2013 | Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray... | The recall was initiated because Shimadzu Corporation has identified a potential issue in certain... | Class II | Shimadzu Medical Systems |
| Mar 15, 2013 | IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model I... | Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information... | Class II | Intuitive Surgical, Inc. |
| Mar 15, 2013 | IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da ... | Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information... | Class II | Intuitive Surgical, Inc. |
| Mar 14, 2013 | The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For... | Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect ... | Class II | Synvasive Technology Inc |
| Mar 13, 2013 | Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories... | Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable conn... | Class II | Masimo Corporation |
| Mar 11, 2013 | All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - M... | The Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead o... | Class I | Lifescan Inc |
| Mar 8, 2013 | APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas L... | Spinal Solutions is recalling the APLIF system because it is not supported by adequate testing an... | Class II | Spinal Solutions, LLC |
| Mar 8, 2013 | Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bra... | Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a p... | Class II | Ormco/Sybronendo |
| Mar 7, 2013 | Orthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers: BG... | Orthopedic Alliance is recalling Blue & Gold Implants and Instruments because the Blue & Gold sys... | Class II | Orthopedic Alliance LLC |
| Mar 6, 2013 | Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-20... | Customer complaint investigation confirmed the issue of false skipped wells and false susceptible... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 6, 2013 | The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Ca... | The Alere Cholestech LDX¿ hsCRP cassette (PN 12-807) may have increased imprecision relative to ... | Class II | Alere San Diego, Inc. |
| Mar 6, 2013 | Alaris PC unit model 8015 with software version 9.12 Product Usage: The... | The recall was initiated because Carefusion has identified potential risk associated with bolus p... | Class II | Carefusion Corporation |
| Mar 6, 2013 | Alaris PC unit model 8015 with software version 9.12 Product Usage: The A... | The recall was initiated because Carefusion has received reports of a communication error on the ... | Class I | Carefusion Corporation |
| Mar 6, 2013 | Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitr... | The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT A... | Class II | Alere San Diego, Inc. |
| Mar 5, 2013 | 1488 HD 3-Chip Camera; Model Number 1488-610-122 - HD 3-Chip Camera Head wit... | In certain operating room environments, a colored screen image occurs with the 1488 Cameras that ... | Class II | Stryker Endoscopy |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | 20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Ca... | Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a cathet... | Class II | Biosense Webster, Inc. |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | 1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline C... | In certain operating room environments, a colored screen image occurs with the 1488 Cameras that ... | Class II | Stryker Endoscopy |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | 1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usa... | In certain operating room environments, a colored screen image occurs with the 1488 Cameras that ... | Class II | Stryker Endoscopy |
| Feb 26, 2013 | IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog ... | Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control in... | Class III | Alere San Diego, Inc. |
| Feb 25, 2013 | LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: ... | When OneTouch¿ Ultra and OneTouch¿ Select test strips are tested with Ultra and Select control so... | Class II | Lifescan Inc |
| Feb 25, 2013 | LifeScan brand OneTouch¿ Select Control Solution, Part Number/Model #: 021689... | When OneTouch¿ Ultra and OneTouch¿ Select test strips are tested with Ultra and Select control so... | Class II | Lifescan Inc |
| Feb 22, 2013 | Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 3... | Kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite... | Class II | Kerr/Pentron, DBA Kerr Corporation and Pentron ... |
| Feb 22, 2013 | Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CS... | Aperio initiated this recall because the User Guides incorrectly state the devices had been clear... | Class II | Aperio Technologies Inc |
| Feb 20, 2013 | 60 mm Rod, Item #BG1660 Product Usage: Spinal Solutions distributes a var... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Spinal Solutions, LLC |
| Feb 20, 2013 | Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, c... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Orthopedic Alliance LLC |
| Feb 20, 2013 | Femoral head, standard, ¿26mm, +0mm Femoral head,medium, ¿26mm,+3mm Femoral... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Orthopedic Alliance LLC |
| Feb 20, 2013 | Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Orthopedic Alliance LLC |
| Feb 20, 2013 | 50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a v... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Spinal Solutions, LLC |
| Feb 20, 2013 | 50 mm Rod, Item #BG1650 Product Usage: Spinal Solutions distributes a var... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Spinal Solutions, LLC |
| Feb 20, 2013 | 40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a var... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Spinal Solutions, LLC |
| Feb 20, 2013 | Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm C... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Spinal Solutions, LLC |
| Feb 20, 2013 | Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr can... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Orthopedic Alliance LLC |
| Feb 20, 2013 | Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Orthopedic Alliance LLC |
| Feb 20, 2013 | Zweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard ... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Orthopedic Alliance LLC |
| Feb 20, 2013 | U2 Acetabular cup, Ti beads porous coated, ¿44mm U2 Acetabular cup, Ti beads... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Orthopedic Alliance LLC |
| Feb 20, 2013 | Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-302... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Orthopedic Alliance LLC |
| Feb 20, 2013 | 12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Spinal Solutions, LLC |
| Feb 20, 2013 | UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Orthopedic Alliance LLC |
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.