Browse Device Recalls
2,437 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,437 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 2,437 FDA device recalls in 2013.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 26, 2013 | Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Mod... | Incorrect size was printed on the outer product packaging. | Class II | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Numbe... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Proc... | LEEP RediKit Products (for use in Loop Electrosurgical Excision Procedures) have Xylocaine (Lidoc... | Class II | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Nu... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| 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 26, 2013 | CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number... | Device with Sample Interference Notes (SIN) enabled not cleared for US marketing. | Class III | Siemens Healthcare Diagnostics Inc |
| Feb 26, 2013 | TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered ... | In certain situations a software problem with the TotalCare SpO2RT¿ 2 bed may occur that can lead... | Class II | Hill-Rom, Inc. |
| Feb 26, 2013 | INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Us... | INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interprete... | Class II | Intio Inc |
| Feb 25, 2013 | MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Prod... | Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets inclu... | Class II | Baxter Healthcare Corp. |
| Feb 25, 2013 | Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 ... | Glucose test strips reports no result message when tested | Class II | Nova Biomedical Corporation |
| Feb 25, 2013 | Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214 | Glucose test strips reports no result message when tested | Class II | Nova Biomedical Corporation |
| Feb 25, 2013 | ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular... | The tabs on the reamer extension device have broken. DePuy is notifying surgeons of the issue to ... | Class II | DePuy Orthopaedics, 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 | CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. ... | Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets inclu... | Class II | Baxter Healthcare Corp. |
| Feb 25, 2013 | Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 Th... | Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range. | Class II | Nipro Diagnostics, Inc. |
| Feb 25, 2013 | MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for ... | Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets inclu... | Class II | Baxter Healthcare Corp. |
| 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 25, 2013 | MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5... | Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets inclu... | Class II | Baxter Healthcare Corp. |
| Feb 25, 2013 | GOPump Elastometric infusion PumpKit with/ and without accesssories all conta... | Received 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became... | Class I | Symbios Medical Products, LLC |
| Feb 24, 2013 | Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used fo... | Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots. | Class II | Clinical Diagnostic Solutions |
| Feb 23, 2013 | Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. How... | Stryker received reports from the field indicating that the handle detached from the cam of the B... | Class II | Stryker Howmedica Osteonics Corp. |
| Feb 22, 2013 | Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: ... | The Trial Head may come loose from the implant stem during manipulation of the arm during surgery... | Class II | Synthes USA HQ, Inc. |
| Feb 22, 2013 | Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000... | The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3 Tubular Plate w/Collar), was released to th... | Class II | Synthes USA HQ, Inc. |
| Feb 22, 2013 | Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) Th... | Siemens Healthcare Diagnostics has initiated a voluntary field action for Dimension(R) PHOS Flex(... | Class II | Siemens Healthcare Diagnostics, 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 21, 2013 | Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used... | Siemens has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 21, 2013 | Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff wit... | Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 Frenc... | Class II | Bard Access Systems |
| Feb 21, 2013 | OsteoSelect DBM Putty Product Usage: Orthopedic bone filler | The firm's retesting procedure was not validated. | Class II | Bacterin International, Inc. |
| Feb 21, 2013 | Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff wi... | Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 Frenc... | Class II | Bard Access Systems |
| 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 | 3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterio... | Manufacturing residue may be present on the cervical screws. Use of this product may result in p... | Class II | Genesys Orthopedic Systems, 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 |
| Feb 20, 2013 | 14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Spinal Solutions, LLC |
| Feb 20, 2013 | Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distrib... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Spinal Solutions, 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.