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FDA Medical Device Recalls

View 10000 FDA Medical Device Recalls on BEUDAMED, the Better Database on Medical Devices. This searchable listing aggregates recall notices issued by the U.S. Food and Drug Administration for devices removed, corrected, or returned due to safety, labeling, or performance concerns. Each record summarizes the recall reason, affected models and lots, recall class, and recommended actions for patients and providers.

Searchable filters help stakeholders identify affected manufacturers, device models, and recall classes (Class I–III) and review timelines and remediation steps. Healthcare providers and purchasers can use these records to verify whether inventory is affected and to implement recommended corrections, returns, or patient notifications.

Straight Linear Cutter 55 mm Blue Digital Loading Unit, product code SLC55B; Straight Linear Cutter 55 mm Green Digital Loading Unit, product code SLC55G; Straight Linear Cutter 55 mm Blue Reload, product code SLCR55B; Straight Linear Cutter 55 mm Green Reload, product code SLCR55G; Straight Linear 4 Row No Knife Digital Loading Unit, product code SLS55B4.

FDA Recall
Terminated ·Surgical Devices/Covidien·Product code GDW·September 23, 2009

Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 25MM, spinal implant component

FDA Recall
Terminated ·Stryker Spine·Product code KWQ·October 2, 2009

28CM ALTA EXCHANGE KIT Model: AL23SH28 XP ALTA EXCHANGE KIT 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Latex free.

FDA Recall
Terminated ·Spire Biomedical, Inc. One Patriots Park·Product code MSD·October 23, 2009

40CM DECATHLON GOLD STD KIT Models: DEC35SH40 and DEC35SH40-K DECATHLON GOLD 15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free.

FDA Recall
Terminated ·Spire Biomedical, Inc. One Patriots Park·Product code MSD·October 23, 2009

Stryker Medical transport stretcher, Stryker Medical, Portage, MI; Model 737 (also known as Model ST104). Wheeled hospital stretcher.

FDA Recall
Terminated ·Stryker Medical Div. of Stryker Corporation·Product code FPO·August 10, 2009

55CM DECATHLON STD KIT Models: DE50SH55 and DE50SH55-K 15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis.

FDA Recall
Terminated ·Spire Biomedical, Inc. One Patriots Park·Product code MSD·October 23, 2009

Norian CRS Rotary Mixer Cement 10cc sterile

FDA Recall
Terminated ·Synthes USA (HQ), Inc.·Product code GXP·September 14, 2009

24CM ALTA LR GOLD STD KIT Model: ALC19SH24 ALTA GOLD 15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free.

FDA Recall
Terminated ·Spire Biomedical, Inc. One Patriots Park·Product code MSD·October 23, 2009

36CM DECATHLON FUNNEL TIP STD KIT Model: DF31SH36 DECATHLON FUNNEL TIP 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free

FDA Recall
Terminated ·Spire Biomedical, Inc. One Patriots Park·Product code MSD·October 23, 2009

Stryker Medical transport stretcher, Stryker Medical, Portage, MI; Model 736. Wheeled hospital stretcher.

FDA Recall
Terminated ·Stryker Medical Div. of Stryker Corporation·Product code FPO·August 10, 2009