Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 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 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 10, 2015 | FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, ... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MO... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | (S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Ste... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | INTEGRAL WAND W/TUBING, STERILE, REF 24185, QTY 24/CS, STERILE EO Intended... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERIL... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Feb 27, 2015 | Lombart 90D Clear with case Visualization during diagnosis and laser therapy... | Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct l... | Class III | Volk Optical Inc |
| Feb 27, 2015 | Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL IN... | Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. | Class III | Volk Optical Inc |
| Feb 27, 2015 | Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extend... | Stryker received four customer complaints reporting that inside the box labeled part #6476-8-260 ... | Class II | Stryker Howmedica Osteonics Corp. |
| Feb 26, 2015 | LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthal... | Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels | Class II | Quest Medical, Inc. |
| Feb 25, 2015 | Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per ... | The outer carton label and package insert for the recalled product incorrectly lists Streptococcu... | Class III | Biomerieux Inc |
| Feb 25, 2015 | Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management. | Nonapproved labeling claims (Sterile) | Class II | Amerx Health Care Corp. |
| Feb 25, 2015 | Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per ... | The outer carton label and package insert for the recalled product incorrectly lists Streptococcu... | Class III | Biomerieux Inc |
| Feb 25, 2015 | Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per ... | The outer carton label and package insert for the recalled product incorrectly lists Streptococcu... | Class III | Biomerieux Inc |
| Feb 24, 2015 | LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI Syste... | Mislabeled with an incorrect expiration date | Class III | LeMaitre Vascular, Inc. |
| Feb 19, 2015 | ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a hu... | Outer shipping carton was marked with an incorrect expiry date, however inner product carton was ... | Class III | Arc Medical Inc |
| Feb 19, 2015 | Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon... | The case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as... | Class III | Richard-Allan Scientific Company |
| Feb 17, 2015 | Double Swivel Connector with Suction Port Connector, Airway (Extension) Kin... | Product is mislabeled as Double Swivel Connector with Suction Port and is actually Double Swivel ... | Class II | King Systems Corp. |
| Feb 13, 2015 | Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic... | Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed... | Class II | Exactech, Inc. |
| Feb 11, 2015 | Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves... | Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes label... | Class II | Sybron Dental Specialties |
| Feb 11, 2015 | Milestone Wand STA Handpiece for the delivery of local anesthesia to dental t... | Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the ST... | Class III | Milestone Scientific, Inc. |
| Feb 10, 2015 | G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glyc... | The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of Oct... | Class III | Tosoh Bioscience, Inc. |
| Feb 9, 2015 | CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02 | Incorrect size printed on the Milex Pessary Kit packaging label | Class II | CooperSurgical, Inc. |
| Feb 9, 2015 | T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, ... | Incorrect labeling of the expiration date | Class II | MRP, LLC dba AMUSA |
| Feb 5, 2015 | ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Cod... | Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rat... | Class II | Arrow International Inc |
| Feb 5, 2015 | Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ... | Use of the product may not provide adequate recovery and could result in false negative identific... | Class II | Remel Inc |
| Feb 4, 2015 | NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Siz... | One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed. | Class II | Zimmer Trabecular Metal Technology, Inc. |
| Jan 23, 2015 | MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Len... | Z-MAX Implant, 9mm diameter, 7mm length labeled package, catalog number Z-MAX9-7, contained a MAX... | Class II | Southern Implants, Inc |
| Jan 21, 2015 | HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with th... | Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user o... | Class II | Intuitive Surgical, Inc. |
| Jan 21, 2015 | HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use ... | Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user o... | Class II | Intuitive Surgical, Inc. |
| Jan 15, 2015 | ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the ... | There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to th... | Class II | Abbott Laboratories, Inc |
| Jan 13, 2015 | LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, ... | The labelling of units from the affected lot indicates that it contains a size 5 LMA Supreme (New... | Class II | Teleflex Medical |
| Jan 13, 2015 | KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A,... | The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument... | Class II | Medtronic Sofamor Danek USA Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601014911, REF/Catalog No. 6010... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601113111, REF/Catalog No. 601... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART CATH KIT, UPN H7496010018151, REF/Catalog N... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H9656002072121, REF/Catalog No. 60... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H965601206511, REF/Catalog No. 60120651, STERILE, ... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART, POTENTIAL REVISION TO 600604412, UPN H965P... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, 3 VALVE MANIFOLD KIT, UPN H749600411611, REF/Catalog N... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496005001131, REF/Catalog No. 60... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601900431, REF/Catalog No. 601... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H749601907851, REF/Catalog No. 60190785, STERILE, ... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, HOPKINS LEFT HEART, UPN H749601836621, REF/Catalog No.... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600309351, REF/Catalog No. 600... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600416321, REF/Catalog No. 600... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, DYE CATH LAB KIT, UPN H749601367131, REF/Catalog No. 6... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496001001111, REF/Catalog No. 60... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H965PK193168S1, REF/Catalog No. PK193168S, STERILE... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602000571, REF/Catalog No. 602... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H965601017731, REF/Catalog No. 601... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, 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.