Browse Device Recalls
86 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 86 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 86 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 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 |
| Dec 14, 2016 | 10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for:... | Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... | Class II | MEDLINE INDUSTRIES INC |
| Dec 14, 2016 | 16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for:... | Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... | Class II | MEDLINE INDUSTRIES INC |
| Dec 14, 2016 | 12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medl... | Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... | Class II | MEDLINE INDUSTRIES INC |
| Dec 14, 2016 | 16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: ... | Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... | Class II | MEDLINE INDUSTRIES INC |
| Dec 14, 2016 | 14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medl... | Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... | Class II | MEDLINE INDUSTRIES INC |
| Nov 23, 2016 | Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in ... | Medline Industries, Inc is recalling Unna Z Unna Boot Bandage 3X10 and Unna Z Unna Boot Bandage... | Class II | Medline Industries Inc |
| Aug 10, 2016 | Rigid Suction Canister 3000 CC and 2000 CC. | Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure dur... | Class II | Medline Industries Inc |
| May 11, 2016 | Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of... | There is 5 mL printed next to the increment on the medicine cups instead of 10 mL. The cup... | Class II | Medline Industries Inc |
| Aug 3, 2015 | Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Wee... | The print plate artwork for this lot was found to state: Central Line <34 Weeks Kit displaying ... | Class II | Medline Industries Inc |
| Jul 8, 2015 | Medline Electrical Clipper with Charging base The Electrical Surgical Cli... | Charging base of surgical clippers overheats and smokes. | Class II | Medline Industries Inc |
| Mar 20, 2014 | Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrap... | This lot did not go through the correct sterilization procedures. This product may potentially be... | Class II | Medline Industries Inc |
| Nov 4, 2013 | Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap;... | There is a potential that the specified mucus specimen traps are not sterile. Use of the affected... | Class II | Medline Industries Inc |
| Nov 8, 2012 | Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescr... | The non-sterile Waste Bag component in the custom pack was attached to the outside of the pack in... | Class II | Medline Industries Inc |
| Sep 20, 2012 | Medline Total Knee CDS; a single patient prescription procedure pack and disp... | The Back Table Cover component in the custom pack was placed in the non-sterile portion of the pa... | 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.