Browse Device Recalls
5,428 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,428 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 5,428 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 13, 2015 | ANSPACH - 4MM x 11 MM Fluted Barrel, 14 Flutes; REF M-4BA-A-G1. Cutting sh... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | Elastic Knee Support. A limb orthosis (brace) is a device intended for med... | The product does not bear the caution label regarding latex content. Potential for Allergic skin... | Class II | United Surgical Associates |
| Apr 13, 2015 | ANSPACH - Extra Coarse Diamond Ball; 8MM REF L-8DX-G1 Cutting shaping bo... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM REF L-6DRC-G1 Cutting sh... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | Elastic Ankle Support. A limb orthosis (brace) is a device intended for me... | The product does not bear the caution label regarding latex content. Potential for Allergic skin... | Class II | United Surgical Associates |
| Apr 13, 2015 | ANSPACH - Fluted Acorn, 7MM REF L-7AC-G1 Cutting shaping bone including s... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 4MM Diamond Ball, Extends 27MM; REF S-4D-L-G1 all lot numbers Cu... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - Fluted Drum, Side Cut Only; 7MM x 14MM REF L-7DRC-G1 Cutting s... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 5MM Diamond Ball, 2MM Shaft Exposure; REF S-5D-2-G1 Cutting s... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone ... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) ... | The product does not bear the caution label regarding latex content. Potential for Allergic skin... | Class II | United Surgical Associates |
| Apr 13, 2015 | ANSPACH - 8MM x 12.5MM Fluted Barrel; REF M-8BA-G1 Cutting shaping bone... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 10, 2015 | 4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine S... | During a field audit it was discovered by an employee that a 16mm Trestle Luxe Screw has been bot... | Class II | Alphatec Spine, Inc. |
| Apr 9, 2015 | Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/5... | Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. The Retail Box an... | Class II | Coloplast Manufacturing US, LLC |
| Apr 8, 2015 | ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Editi... | Baxter Corporation is conducting a field action for the ABACUS SE and ME models due to the possib... | Class II | Baxter Corporation Englewood |
| Apr 7, 2015 | HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter... | HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as con... | Class II | Catheter Research, Inc |
| Apr 1, 2015 | Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the... | If a user requests slides from the LIS or TPID, then updates a request by changing the test, the ... | Class II | Dako North America Inc. |
| Mar 30, 2015 | Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 i... | A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gaug... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Mar 26, 2015 | Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound o... | The labeling for the Iamin family of medical devices (e.g. printed and internet text) is not cons... | Class II | PhotoMedex, Inc. |
| Mar 25, 2015 | Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1:... | Accessories to the GYC-1000 laser were missing Laser Aperture labels. | Class II | Nidek Inc |
| Mar 25, 2015 | Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator S... | Accessories to the GYC-1000 laser were missing Laser Aperture labels. | Class II | Nidek Inc |
| Mar 20, 2015 | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, ... | Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in u... | Class II | Axis-Shield Diagnostics, Ltd. |
| Mar 19, 2015 | Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable... | A previous Turkish distributor over-labeled a portion of the lot with an expiration date of 2016-... | Class II | Incisive Surgical Inc |
| Mar 17, 2015 | CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage... | A drop in staining intensity over time has been observed. These lots may not meet their labeled s... | Class II | Biocare Medical, LLC |
| Mar 13, 2015 | Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile dev... | A lot of Flowable Wound Matrix that has been distributed to customers in late 2013 / early 2014 w... | Class II | Integra LifeSciences Corp. |
| Mar 13, 2015 | PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc... | Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum F... | Class II | Bard Access Systems |
| Mar 11, 2015 | Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation devi... | One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x... | Class II | X Spine Systems Inc |
| Mar 10, 2015 | LASER RESISTANT WAND - STERILE, 7/8" X 8" (2.22cm x 20.32cm), REF 24013, QT... | 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), WITH TUBING EXTENDER, STERILE, R... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | LAPAROSCOPIC TUBING SET, 3/16" ¿ X 10' (48cm x 304.8cm) WITH MALE LUER LOCK -... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO I... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/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) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX ... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm ... | 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 WITH MOTOR MODULE, REF 11113STK, 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 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 |
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.