Browse Device Recalls
2,729 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,729 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 2,729 FDA device recalls in 2014.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 26, 2014 | Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-... | This recall provides important new information regarding overinfusion associated with the Medtron... | Class II | Medtronic Neuromodulation |
| Feb 26, 2014 | Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique an... | Incorrect labeling on specific lots of the Intramedullary Bone Saw.The Saw Blade Assembly was ide... | Class II | Biomet, Inc. |
| Feb 26, 2014 | Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Bi... | Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was id... | Class II | Biomet, Inc. |
| Feb 26, 2014 | Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL... | Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (Product Code: NCL-L-GS... | Class II | Leica Microsystems, Inc. |
| Feb 26, 2014 | Safety glasses made with "Rage" frames manufactured between February 20, 2014... | Fifteen pairs of prescription, safety glasses did not meet required, industrial lens thickness; n... | Class II | Wal Mart Stores, Inc |
| Feb 25, 2014 | Apollo" Knee System: APOLLO PATELLA SZ0 28MM R | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... | Class II | Zimmer, Inc. |
| Feb 25, 2014 | Apollo" Knee System: PS TIB INS SZ0/16MM APOLL PS TIB INS SZ0/19MM APOLL P... | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... | Class II | Zimmer, Inc. |
| Feb 25, 2014 | Natural-Knee¿ II System: POLY ULTRA TIB LT SZ00/9M POLY ULTRA TIB LT SZ0/9M... | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... | Class II | Zimmer, Inc. |
| Feb 25, 2014 | LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inc... | Hospira identified an incorrect lower lid (set component) had been supplied and was being used du... | Class II | Hospira Inc. |
| Feb 25, 2014 | Apollo" Revision/Constrained Knee System: SZ0-16MM AK CCK TIB INSER SZ1-11M... | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... | Class II | Zimmer, Inc. |
| Feb 25, 2014 | Natural-Knee¿ II System ULTRA CONG INS LT SZA/9MM ULTRA CONG INS LT SZA/13M... | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... | Class II | Zimmer, Inc. |
| Feb 25, 2014 | Gender Solutions" Natural-Knee¿ Flex System: N-K FLEX MBACK SZ 0 PAT N-K FL... | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... | Class II | Zimmer, Inc. |
| Feb 25, 2014 | Natural-Knee¿ II Constrained Knee System NKII CCK TIB INS SZ00/0-L NKII CCK... | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... | Class II | Zimmer, Inc. |
| Feb 25, 2014 | Natural-Knee¿ II Unicompartmental Knee System: UNI ALL-POLY TIB SZ 1-7mm UN... | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... | Class II | Zimmer, Inc. |
| Feb 25, 2014 | Natural-Knee¿ Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 ... | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... | Class II | Zimmer, Inc. |
| Feb 25, 2014 | MOST Options" System (MOST) HINGED TIB INS SZ 1 16MM HINGED TIB INS SZ 4 6M... | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... | Class II | Zimmer, Inc. |
| Feb 25, 2014 | Natural-Knee¿ N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1 | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... | Class II | Zimmer, Inc. |
| Feb 25, 2014 | Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO ... | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... | Class II | Zimmer, Inc. |
| Feb 25, 2014 | Natural-Knee¿ II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM ... | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... | Class II | Zimmer, Inc. |
| Feb 25, 2014 | Natural-Knee¿ II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II... | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... | Class II | Zimmer, Inc. |
| Feb 25, 2014 | Natural-Knee¿/Apollo" Knee: M/B PAT SZ0 NATURAL-KNEE M/B PAT SZ1 NATURAL-KN... | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... | Class II | Zimmer, Inc. |
| Feb 24, 2014 | REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (wit... | DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexi... | Class II | DePuy Orthopaedics, Inc. |
| Feb 24, 2014 | ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalog... | When using multiple radiation treatment targets within a single plan, the ExacTrac v.6.0.3 might ... | Class II | Brainlab AG |
| Feb 24, 2014 | Myriad handpiece Tissue morcellator | This recall has been initiated due to a defective component within the handpiece which will caus... | Class II | Nico Corp. |
| Feb 24, 2014 | REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (wi... | DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexi... | Class II | DePuy Orthopaedics, Inc. |
| Feb 24, 2014 | REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (w... | DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexi... | Class II | DePuy Orthopaedics, Inc. |
| Feb 24, 2014 | AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Sprin... | The Lock Nut component of the Jet appliances may be missing the screw collar, which serves as a m... | Class II | Allesee Orthodontic Appliances |
| Feb 24, 2014 | REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (w... | DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexi... | Class II | DePuy Orthopaedics, Inc. |
| Feb 24, 2014 | REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (w... | DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexi... | Class II | DePuy Orthopaedics, Inc. |
| Feb 24, 2014 | REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (wi... | DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexi... | Class II | DePuy Orthopaedics, Inc. |
| Feb 21, 2014 | DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product... | Moldy smell in product | Class II | DeRoyal Industries Inc |
| Feb 21, 2014 | MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.0... | Potential for erroneous result reporting. | Class II | Medical Information Technology, Inc. |
| Feb 20, 2014 | Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1... | ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion... | Class II | ConMed Corporation |
| Feb 20, 2014 | VITROS TT4 Calibrator For the quantitative measurement of total thyroxine ... | Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results. | Class II | Ortho-Clinical Diagnostics |
| Feb 20, 2014 | PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Cat... | Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have part... | Class II | Biosense Webster, Inc. |
| Feb 19, 2014 | Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon I... | The possibility exists that an incomplete seal on the packaging compromised the sterility of the ... | Class II | Ethicon, Inc. |
| Feb 19, 2014 | Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes,... | The bar code that is printed on the Master Carton label does not correspond to the product code f... | Class III | Medefil Incorporated |
| Feb 19, 2014 | FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Dis... | Abbott Diabetes Care has identified through internal testing and investigation that all non-appli... | Class I | Abbott Diabetes Care, Inc. |
| Feb 19, 2014 | FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. S... | Abbott Diabetes Care has identified through internal testing and investigation that all non-appli... | Class I | Abbott Diabetes Care, Inc. |
| Feb 19, 2014 | Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and R... | Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, ... | Class II | Gyrus Medical, Inc |
| Feb 18, 2014 | Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J... | ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which co... | Class II | Philips Medical Systems, Inc. |
| Feb 18, 2014 | Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; I... | Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified thro... | Class III | Lin-Zhi International Inc |
| Feb 18, 2014 | HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J... | Philips HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experienc... | Class II | Philips Medical Systems, Inc. |
| Feb 18, 2014 | ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyze... | Instrument Cover Gas Spring failures. Over time, the gas spring may lose its effectiveness and f... | Class II | Siemens Healthcare Diagnostics |
| Feb 18, 2014 | Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0... | Some of the discs may not be impregnated with the antibiotic. | Class II | Remel Inc |
| Feb 18, 2014 | Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A,... | MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the... | Class II | Philips Medical Systems, Inc. |
| Feb 18, 2014 | GemStar Docking Station, used with GemStar infusion pump, in combination with... | There are two situations that may occur when using the GemStar Docking Station, List Number 13075... | Class I | Hospira Inc. |
| Feb 18, 2014 | HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M... | A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge ... | Class II | Philips Medical Systems, Inc. |
| Feb 18, 2014 | Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with ... | When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may ... | Class II | Philips Medical Systems, Inc. |
| Feb 18, 2014 | M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart M... | Wireless Link may be unable to transmit data when configured for a specific data flow. | Class II | Philips Medical Systems, Inc. |
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.