Browse Device Recalls
1,303 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,303 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 1,303 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 14, 2020 | Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAM... | Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... | Class II | Medline Industries Inc |
| Sep 14, 2020 | Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage:... | Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... | Class II | Medline Industries Inc |
| Sep 14, 2020 | Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage:... | Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... | Class II | Medline Industries Inc |
| Sep 14, 2020 | Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NA... | Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... | Class II | Medline Industries Inc |
| Sep 14, 2020 | Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NA... | Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... | Class II | Medline Industries Inc |
| Sep 14, 2020 | Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Us... | Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... | Class II | Medline Industries Inc |
| Sep 1, 2020 | ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL T... | There have been reports of the suction catheter coming apart from the device assembly during use. | Class II | Medline Industries Inc |
| Aug 12, 2020 | Central Line Dressing Change Tray | Potential of incomplete seals impacting the sterility of the kit. | Class II | Medline Industries Inc |
| Jul 28, 2020 | Control, Calibrator Verified, Triage BNP, Model ALR88755 | Product was shipped with refrigeration (ice) instead of frozen (dry ice). | Class II | Medline Industries Inc |
| Jul 9, 2020 | Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are si... | Potential risk of brush detachment during cleaning. | Class II | Medline Industries Inc |
| Jun 30, 2020 | ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ... | There are reports of the suction catheter coming apart from the device assembly during use. | Class II | Medline Industries Inc |
| Jun 30, 2020 | ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 ... | There are reports of the suction catheter coming apart from the device assembly during use. | Class II | Medline Industries Inc |
| Mar 9, 2020 | Custom convenience kits containing Medline brand Sterile Pre-Saturated Povido... | Medline identified that there may be a potential for voids in the packaging seal and loss of ster... | Class II | Medline Industries Inc |
| Feb 10, 2020 | Medline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration... | Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... | Class II | Medline Industries Inc |
| Feb 10, 2020 | Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G... | Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... | Class II | Medline Industries Inc |
| Feb 10, 2020 | Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expirat... | Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... | Class II | Medline Industries Inc |
| Jan 21, 2020 | Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 e... | The sterile pack inside the Complete Delivery System (CDS) did not go through a complete steriliz... | Class II | Medline Industries Inc |
| Jan 21, 2020 | Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTI... | The sterile pack inside the Complete Delivery System (CDS) did not go through a complete steriliz... | Class II | Medline Industries Inc |
| Jan 7, 2020 | Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malays... | There is potential for the sterile wrap to become loose while in transit and compromise the steri... | Class II | Medline Industries Inc |
| Oct 30, 2019 | Anesthesia Pediatric Circuit 72", Model DYNJAPF6057A | The 10mm inner green inspiratory tubing is disconnected from the tee connector at the machine end... | Class II | Medline Industries Inc |
| Sep 18, 2019 | EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil p... | Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips. | Class II | Medline Industries Inc |
| Sep 6, 2019 | MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800 Product Usage: ... | The recall is being conducted due to a potential defective component on the circuit board causing... | Class II | Medline Industries Inc |
| Aug 9, 2019 | Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigati... | Samples in the identified lot were found to have incomplete or open packaging seals. | Class II | Medline Industries Inc |
| May 30, 2019 | Anti-fog solution packaged in a Tyvek peel pouch and it is placed into variou... | The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties. | Class II | Medline Industries, Inc. |
| May 28, 2019 | SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage... | Loose silicone particulate was found to be present on the shaft of the silicone catheters. | Class II | Medline Industries Inc |
| May 28, 2019 | SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usag... | Loose silicone particulate was found to be present on the shaft of the silicone catheters. | Class II | Medline Industries Inc |
| May 28, 2019 | SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage:... | Loose silicone particulate was found to be present on the shaft of the silicone catheters. | Class II | Medline Industries Inc |
| May 10, 2019 | Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets. BD code ... | This recall is a sub recall to BD s recent Class I recall for the Alaris Pump Infusion Set due to... | Class I | Medline Industries Inc |
| May 3, 2019 | Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warm... | The Vyaire enFlow disposable cartridge was recalled due to the potential for unsafe aluminum leve... | Class I | Medline Industries Inc |
| Apr 25, 2019 | Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: T... | Potential risk of brush detachment during cleaning. If brush detachment is not identified, there... | Class II | Medline Industries Inc |
| Jan 31, 2019 | Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR... | Potential for the Semi-Rigid canister lid to fragment during use. | Class II | Medline Industries Inc |
| Aug 30, 2018 | Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers... | Firm received sporadic reports of discoloration on certain lots of the product, which has been id... | Class II | MEDLINE INDUSTRIES INC |
| Jun 15, 2018 | Endoscopic Cleaning Brush, single use, sold in kits and labeled as the follow... | There is potential risk of brush detachment during cleaning. If brush detachment is not identifi... | Class II | Medline Industries Inc |
| Apr 24, 2018 | MEDLINE Sterile* Needle Counter, 100Ct. Double Magnet / Foam Block, reorder: ... | The product packaging seal has the potential to experience seal creep. This may result in gaps to... | Class II | Medline Industries Inc |
| Apr 24, 2018 | MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Magnet, reorder: DYNJNC40... | The product packaging seal has the potential to experience seal creep. This may result in gaps to... | Class II | Medline Industries Inc |
| Apr 24, 2018 | MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / ... | The product packaging seal has the potential to experience seal creep. This may result in gaps to... | Class II | Medline Industries Inc |
| Apr 24, 2018 | MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet /... | The product packaging seal has the potential to experience seal creep. This may result in gaps to... | Class II | Medline Industries Inc |
| Apr 24, 2018 | MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de... | The product packaging seal has the potential to experience seal creep. This may result in gaps to... | Class II | Medline Industries Inc |
| Apr 24, 2018 | MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC... | The product packaging seal has the potential to experience seal creep. This may result in gaps to... | Class II | Medline Industries Inc |
| Feb 1, 2018 | Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR ... | Packaged with an incorrect overwrap. | Class II | Medline Industries Inc |
| Jan 12, 2018 | BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile... | One of the cases of product might not have been sterilized. | Class II | Medline Industries, Inc. |
| Oct 23, 2017 | Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pou... | Possible open seal on top portion of the package. Could cause breach of sterility. | Class II | Medline Industries Inc |
| Oct 18, 2017 | Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (... | Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled... | Class II | Bioseal Corporation |
| Oct 16, 2017 | DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep ... | Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled ... | Class II | DeRoyal Industries Inc |
| Oct 10, 2017 | MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8 | Products labeled as sterile were distributed prior to sterilization | Class II | Medline Industries Inc |
| Oct 10, 2017 | MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHE... | Products labeled as sterile were distributed prior to sterilization | Class II | Medline Industries Inc |
| Aug 10, 2017 | Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic ba... | The locking mechanism on the belt may fail to secure/hold the strap when in locked position poten... | Class II | Medline Industries Inc |
| Aug 10, 2017 | Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic ba... | The locking mechanism on the belt may fail to secure/hold the strap when in locked position poten... | Class II | Medline Industries Inc |
| Jul 18, 2017 | Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek pla... | Product did not undergo correct sterilization procedures and may potentially be non-sterile. | Class II | Medline Industries Inc |
| Apr 12, 2017 | LASER CDS | Multiple surgical packs were assembled with a non-sterile CHG applicators labeled as "ChloraPrep"... | Class II | Medline Industries, 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.